Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX

mTSS: sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score).

mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.

ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender joints count (TJC) or swollen joints count (SJC) and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of the Health Assessment Questionnaire [HAQ]), and 5) C-reactive protein (CRP).

BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.

BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.

mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score).

mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.

mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). A increase of less than or equal to (≤)0.5 in mTSS is considered to be no progression in the mTSS.

Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. An increase of ≤0.5 in Erosion Score is considered to be 'no worsening' in the Erosion Score.

Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280.

JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168.

Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. Change = score at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.

JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.

ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.

ACR20 response: ≥20% improvement in TJC or SJC and ≥20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.

ACR50 response: ≥50% improvement in TJC or SJC and ≥50% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.

Sixty-eight (68) joints were assessed by a blinded joint assessor to determine the number of joints considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 68 joints to be assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal (IP), proximal interphalangeals (PIP II, III, IV, V), distal interphalangeals (DIP II, III, IV, V); lower extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).

Sixty-eight (68) joints were assessed by a blinded joint assessor to determine the number of joints considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 68 joints to be assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).

Sixty-six (66) joints were assessed by a blinded joint assessor for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 66 joints assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).

Sixty-six (66) joints were assessed by a blinded joint assessor for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 66 joints assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).

Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm=no pain and 100 mm=most severe pain.

Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm=no pain and 100 mm=most severe pain.

Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm=very good and 100 mm=very bad.

Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm=very good and 100 mm=very bad.

Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly.

Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly.

CRP measured in milligrams per liter (mg/L)

Change from Baseline in CRP measured in mg/L.

DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) less than or equal to (≤)3.2 implied low disease activity, greater than (>)3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) less than (<)2.6 = remission.

DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeter/hour [mm/hour]) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.

DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.

DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.

DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.

DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.

DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.

DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.

DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from baseline [BL]), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).

DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from BL), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).

ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.

ACR20 response: ≥20% improvement in TJC or SJC and ≥20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.

ACR50 response: ≥50% improvement in TJC or SJC and ≥50% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.

ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.

DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.

DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time).

WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time).

WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0 [no loss] to 100 [complete loss of work]).

WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0 [no loss] to 100 [complete loss of work]).

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.

RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.

RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.

RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.

RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.

RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.

RA-HCRU assessed healthcare (HC) usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done, and work missed were reported.

RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done, and work missed were reported.

Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.

RA-HCRU assessed HC usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.

RA-HCRU assessed HC usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.

RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.

RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.

RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.

RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.

RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home HC services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.

RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home HC services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.

Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.

Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.

MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported

Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.

Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.

Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.

FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status

FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status