Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2)

EULAR response was assessed at the end of Month 6 by the Disease Activity Score using the 28 tender and swollen joint count calculated with erythrocyte sedimentation rate values (DAS28-ESR). A good response was defined as a decrease >1.2 units and a final DAS28-ESR < 3.2 units, while a moderate response was defined as a decrease > 1.2 units and final DAS28-ESR >= 3.2 units, OR a decrease of 0.6 to 1.2 units AND final DAS28-ESR <= 5.1 units

The number of participants experiencing DAS28-ESR remission was evaluated at the start of study Month 11 and the end of study Month 12. The DAS28-ESR is expressed on a unit on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR <2.6.

The mean change from baseline in the mean number of swollen joints was calculated at study Month 2, Month 4, and Month 6 by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week). A total of 28 joints were evaluated.

The mean change from baseline in the number of swollen joints was calculated by participant baseline background DMARD treatment regimen at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.

The mean change from baseline in the number of swollen joints by participant baseline concomitant corticosteroid treatment was calculated at study Month 2, Month 4, and Month 6 . A total of 28 joints were evaluated.

The mean change from baseline in the mean number of swollen joints by the number of baseline participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.

The mean change from baseline in the mean number of swollen joints was calculated by the participant duration of disease at study Month 2, Month 4, and Month 6. The participant duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. A total of 28 joints were evaluated.

The mean change from baseline in the number of swollen joints by participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6 by the participant's level of baseline disease activity, as measured by DAS28-ESR. A total of 28 joints were evaluated. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.

The change from baseline in the mean number of swollen joints was calculated by the participant baseline level of RF at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.

The change from baseline in the mean number of swollen joints was calculated by the participant baseline level of anti-CCP at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.

The change from baseline in the mean number of swollen joints was calculated by the baseline participant smoking status at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.

The change from baseline in the mean number of swollen joints was calculated by the baseline participant eligibility for anti-TNF treatment at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.

The mean change from baseline in the number of swollen joints was calculated by the participant baseline expectation of treatment outcome at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).

The mean change from baseline in the number of swollen joints was calculated by the physician experience level at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis.

The mean change from baseline in the number of swollen joints was calculated by the physician experience level with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.

The mean change from baseline in the number of swollen joints was calculated by the baseline number of patients the physician treats with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The number of patients treated with biologics is defined as the number of patients treated by the physician in the last month with biologics for rheumatoid arthritis.

The mean change from baseline in the number of swollen joints was calculated by the physician's expectation of treatment outcome at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The physician's expectation of treatment outcomes was assessed at the start of Month 4 at which time physicians were asked to rate their expectations of treatment outcome in each participant as: high disease activity, moderate disease activity, low disease activity, or remission.

The mean change from baseline in the number of tender joints was calculated by participant concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.

The mean change from baseline in the number of tender joints was calculated by participant background DMARD treatment at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.

The mean change from baseline in the number of tender joints was calculated by participant baseline concomitant steroid treatment at study Month 2, Month 4, and Month 6. A total 28 joints were evaluated.

The mean change from baseline in the number of tender joints was calculated by the number of participant DMARD failures at baseline at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated.

The mean change from baseline in the number of tender joints was calculated by the participant duration of disease at study Month 2, Month 4, and Month 6. Duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. A total of 28 joints were evaluated.

The mean change from baseline in the number of tender joints was calculated by the participant baseline level of disease activity, as measured by DAS28, at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.

The change from baseline in the mean number of tender joints was calculated by the participant baseline level of RF at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.

The mean change from baseline in the number of tender joints was calculated by the participant baseline level of anti-CCP at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.

The mean change from baseline in the number of tender joints was calculated by the baseline participant smoking status at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.

The mean change from baseline in the number of tender joints was calculated by the baseline participant eligibility for anti-TNF treatment at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.

The mean change from baseline in the number of tender joints was calculated by the participant baseline expectation of treatment outcome at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).

The mean change from baseline in the number of tender joints was calculated by the physician experience level at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis.

The mean change from baseline in the number of tender joints was calculated by the physician experience level with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.

The mean change from baseline in the number of tender joints was calculated by the baseline number of patients the physician treats with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The number of patients treated with biologics is defined as the number of patients treated by the physician in the last month with biologics for rheumatoid arthritis.

The mean change from baseline in the number of tender joints. was calculated by the physician's expectation of treatment outcome at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The physician's expectation of treatment outcomes was assessed at the start of Month 4 at which time physicians were asked to rate their expectations of treatment outcome in each participant as: high disease activity, moderate disease activity, low disease activity, or remission.

The mean change from baseline in participant global assessment of disease activity was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a visual analogue scale (VAS; 0mm [best] -100mm [worst]) with increasing scores indicating increased level of disease.

The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.

The mean change from baseline in the participant global assessment of disease activity by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.

The mean change from baseline in the participant global assessment of disease activity score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.

The mean change from baseline in the participant global assessment of disease activity by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.

The mean change from baseline in the participant global assessment of disease activity by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.

The mean change from baseline in the participant global assessment of disease activity by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.

The mean change from baseline in the participant global assessment of disease activity by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.

The mean change from baseline in the participant global assessment of disease activity by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.

The mean change from baseline in the participant global assessment of disease activity by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.

The mean change from baseline in the participant global assessment of disease activity by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).

The mean change from baseline in the participant global assessment of disease activity by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.

The mean change from baseline in the participant global assessment of disease activity by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.

The mean change from baseline in the participant global assessment of disease activity by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.

The mean change from baseline in the participant global assessment of disease activity by the physician's expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.

The change from baseline in participant serum ESR was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6.

The mean change from baseline in participant serum ESR by concomitant DMARD background treatment was calculated at study Month 2, Month 4, and Month 6. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.

The mean change from baseline in serum ESR by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6.

The mean change from baseline in participant serum ESR by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6.

The mean change from baseline in the participant serum ESR by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis.

The mean change from baseline in participant serum ESR by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.

The mean change from baseline in participant serum ESR by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6.

The mean change from baseline in ESR by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6.

The mean change from baseline in participant serum ESR by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.

The mean change from baseline in participant serum ESR by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6.

The mean change from baseline in participant serum ESR by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).

The mean change from baseline in participant serum ESR by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.

The mean change from baseline in participant serum ESR by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.

The mean change from baseline in participant serum ESR by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.

The mean change from baseline in participant serum ESR by the physician's expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.

The change from baseline in participant serum CRP was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6.

The mean change from baseline in participant serum CRP by concomitant DMARD background treatment was calculated at study Month 2, Month 4, and Month 6. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.

The mean change from baseline in serum CRP by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6.

The mean change from baseline in participant serum CRP by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6.

The mean change from baseline in the participant serum CRP by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis.

The mean change from baseline in participant serum CRP by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. DAS28-ESR scores of > 3.2 to <=5.1 indicate moderate disease activity and DAS28-ESR scores of > 5.1 indicate high disease activity.

The mean change from baseline in participant serum CRP by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6.

The mean change from baseline in CRP by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6.

The mean change from baseline in participant serum CRP by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.

The mean change from baseline in participant serum CRP by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6.

The mean change from baseline in participant serum CRP by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).

The mean change from baseline in participant serum CRP by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.

The mean change from baseline in participant serum CRP by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.

The mean change from baseline in participant serum CRP by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.

The mean change from baseline in participant serum CRP by the physician's expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.

The mean change from baseline in physician global assessment of disease activity was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.

The mean change from baseline in the physician global assessment of disease by concomitant DMARD background treatment was evaluated at Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.

The mean change from baseline in the physician global assessment of disease activity by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.

The mean change from baseline in the physician global assessment of disease activity score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.

The mean change from baseline in the physician global assessment of disease activity by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.

The mean change from baseline in the physician global assessment of disease activity by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.

The mean change from baseline in the physician global assessment of disease activity by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.

The mean change from baseline in the physician global assessment of disease activity by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.

The mean change from baseline in the physician global assessment of disease activity by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.

The mean change from baseline in the physician global assessment of disease activity by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.

The mean change from baseline in the physician global assessment of disease activity by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] -100mm [worst]) with increasing scores indicating increased level of disease. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).

The mean change from baseline in the physician global assessment of disease activity by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.

The mean change from baseline in the physician global assessment of disease activity by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.

The mean change from baseline in the physician global assessment of disease activity by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.

The mean change from baseline in the physician global assessment of disease activity by the baseline physician expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.

The mean change from baseline in the DAS28-ESR was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission.

The DAS28-ESR measures disease burden using patient global health (self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX+sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide.

The mean change from baseline in the DAS28-ESR by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR <3.2 = low disease activity, and DAS28-ESR <2.6 = remission.

The mean change from baseline in the DAS28-ESR score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed on a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission.

The mean change from baseline in the DAS28-ESR score by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed on a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR >5.1 = high disease activity, DAS28-ESR <3.2 = low disease activity, and DAS28-ESR <2.6 = remission.

The mean change from baseline in the DAS28-ESR score by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR with increasing scores indicating increased level of disease burden. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.

The mean change from baseline in the DAS28-ESR by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. Increasing scores indicate increased burden of disease. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission.

The mean change from baseline in the DAS28-ESR score by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. Increasing scores indicate increased burden of disease. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission.

The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.

The mean change from baseline in the DAS28-ESR score by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission.

The mean change from baseline in the DAS28-ESR score by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).

The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.

The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.

The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.

The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.

The mean change from baseline in the DAS28-CRP was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.

The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts & swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP >5.1 =high disease activity, DAS28-CRP <3.2=low disease activity, and DAS28-CRP <2.6=remission. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 =leflunomide.

The mean change from baseline in the DAS28-CRP by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.

The mean change from baseline in the DAS28-CRP score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.

The mean change from baseline in the DAS28-CRP score by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.

The mean change from baseline in the DAS28-CRP score by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP with increasing scores indicating increased burden of disease. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-CRP > 5.1 = high disease activity, DAS28-CRP < 3.2 to < =5.1 = low disease activity, and DAS28-CRP <2.6 = remission.

The mean change from baseline in the DAS28-CRP by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.

The mean change from baseline in the DAS28-CRP score by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.

The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.

The mean change from baseline in the DAS28-CRP score by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.

The mean change from baseline in the DAS28-CRP score by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).

The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.

The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.

The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.

The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.

The mean change from baseline in the SDAI was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).

The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide.

The mean change from baseline in the SDAI by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0 cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).

The mean change from baseline in the SDAI by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).

The mean change from baseline in the SDAI by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).

The mean change from baseline in the SDAI by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease with increasing scores indicating increased burden of disease. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).

The mean change from baseline in the SDAI by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).

The mean change from baseline in the SDAI by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).

The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).

The mean change from baseline in the SDAI by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).

The mean change from baseline in the SDAI by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).

The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.

The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.

The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.

The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.

EULAR response was assessed at the end of Month 2, Month 4, and Month 6 by the Disease Activity Score using the 28 tender and swollen joint count calculated with erythrocyte sedimentation rate values (DAS28-ESR). A good response would was defined as a decrease >1.2 units and a final DAS28-ESR < 3.2 units, while a moderate response was defined as a decrease > 1.2 units and final DAS28-ESR >= 3.2 units, OR a decrease of 0.6 to 1.2.

DAS28-CRP EULAR response is defined as a good or moderate response that results in a DAS28-CRP >=0.6.

The number of participants achieving low disease activity or remission was calculated by the DAS28-ESR, DAS28-CRP, and SDAI at study Month 2, Month 4, and Month 6. Low disease activity by DAS28-ESR was defined as >= 2.6 to 3.2, and remission was defined as a DAS28-ESR <2.6. Low disease activity by DAS28-CRP was defined as DAS28-CRP >=2.6 to 3.2, and remission was defined as DAS28-CRP >2.6. Low disease activity by SDAI was defined as SDAI >5.0 to <=20, and remission was defined as SDAI <=5.0.

The mean change from baseline the disability index of the HAQ was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst)with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).

The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide.

The mean change from baseline in the HAQ-DI by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).

The mean change from baseline in the HAQ-DI by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).

The mean change from baseline in the HAQ-DI by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).

The mean change from baseline in the HAQ-DI by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.

The mean change from baseline in the HAQ-DI by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).

The mean change from baseline in the HAQ-DI by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).

The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.

The mean change from baseline in the HAQ-DI by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).

The mean change from baseline in the HAQ-DI by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).

The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.

The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.

The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a scores ranging from 0 (best) to 3 (best) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.

The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.

The number of participants that achieved minimal or absence of functional impairment as assessed by the HAQ at study Month 2, Month 4, and Month 6 was calculated. Minimal or absence of functional impairment was defined as a HAQ score of <=0.5. The HAQ evaluates participants on a scale of 0 to 3, with 0=with no difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do.

Concomitant MTX dose was defined as low < 10mg/wk, medium >= 10 to < 15 mg/week, and and high >=15 mg/week. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.

The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. DMARD Combination 1=MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2=MTX + leflunomide; Combination 3=MTX +sulfasalazine; Combination 4=MTX + hydrochloroquine, chloroquine, chloroquine phosphate+sulfasalazine; Combination 5=leflunomide.

The mean change from baseline in the EQ-5D by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.

The mean change from baseline in the EQ-5D by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.

The mean change from baseline in the EQ-5D by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.

The mean change from baseline in the EQ-5D by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.

The mean change from baseline in the EQ-5D by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.

The mean change from baseline in the EQ-5D by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.

The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.

The mean change from baseline in the EQ-5D by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.

The mean change from baseline in the EQ-5D by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).

The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.

The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.

The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.

The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant indicates their health state by ticking the box against the most appropriate statement. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.

The number of participants achieving PASS was evaluated at study Month 2, Month 4, and Month 6 was calculated. PASS is participant self-evaluation tool that uses a VAS 0mm (best) - 100mm (worst), with a score <=31 representing an acceptable PASS.

The DAS28-ESR is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR, and participant assessment of disease activity measure on a visual analogue scale. The DAS28-ESR has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Minimum score=0 (best) to maximum score=10 (worst). The DAS28-ESR area under the curve can be calculated from the DAS28-ESR score versus time curve to provide an assessment of changes in disease activity over time.

The area under the DAS28-ESR score versus time curve was computed using the trapezoidal rule and using raw DAS28-ESR score values at Part-2 Baseline, end of Month 12, and at least 2 intermediate time points. The DAS28-ESR area under the curve was then averaged over the total duration (months) and expressed as units on a scale.

Remission was defined as achievement of a DAS28-ESR < 2.6.