Pfizer
Collegeville, Pennsylvania, 19426, United States
NCT Number: NCT05375942
This is a retrospective observational study looking at the characteristics and outcomes of participants taking Inflectra using the CorEvitas Rheumatoid Arthritis Registry.
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Notify Me18 year and older
All sexes
Observational
Collegeville, Pennsylvania, 19426, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 6 Months (from the retrospective data collected from the CorEvitas RA registry)
Clinical disease activity index (CDAI) was the numerical sum of 4 outcome parameters: tender and swollen joint count based on a 28-joint assessment, participant global assessment and physician global assessment assessed on 0 to 10 millimeter (mm) visual analogue scale (VAS) where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). Total score for CDAI ranged from 0 to 76 with higher score indicating greater disease activity. Participants who achieved LDA had CDAI score less than or equal to (<=)10. Participants with moderate or high disease activity (CDAI greater than [>]10) at baseline were analyzed for this outcome measure.
Time frame: 6 Months (from the retrospective data collected from the CorEvitas RA registry)
CDAI was the numerical sum of 4 outcome parameters: tender and swollen joint count based on a 28-joint assessment, participant global assessment and physician global assessment assessed on 0 to 10 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). Total score for CDAI ranged from 0 to 76 with higher score indicating greater disease activity. Participants who achieved clinical remission had a CDAI score <=2.8. Participants with low, moderate or high disease activity (CDAI>2.8) at baseline were analyzed for this outcome measure.
Time frame: Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry)
CDAI was the numerical sum of 4 outcome parameters: tender and swollen joint count based on a 28-joint assessment, participant global assessment and physician global assessment assessed on 0 to 10 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). CDAI total score = 0 to 76, higher scores=greater affection due to disease activity. CDAI <2.8 indicated disease remission, 2.8 to <10 indicated low disease activity, 10 to <22 indicated moderate disease activity, and >=22 indicated high disease activity.
Time frame: Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry)
HAQ: participant-reported questionnaire for the assessment of rheumatoid arthritis. It comprised of 20 questions in 8 categories of activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and activities over past week. Each activity was assessed on a 4-point Likert scale from 0 to 3, where 0 = without difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning.
Time frame: Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry)
Participant pain was measured on a VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst).
Time frame: Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry)
Participant fatigue was measured on a VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.
Time frame: 6 Months (from the retrospective data collected from the CorEvitas RA registry)
mACR20 response: >= 20% improvement in tender and swollen joint count and 20% improvement in two of the following four criteria: 1) participant assessment of pain (scored from 0 mm to 100 mm, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function).
Time frame: 6 Months (from the retrospective data collected from the CorEvitas RA registry)
mACR50 response: >= 50% improvement in tender and swollen joint count and 50% improvement in two of the following four criteria: 1) participant assessment of pain (scored from 0 mm to 100 mm, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function).
Time frame: 6 Months (from the retrospective data collected from the CorEvitas RA registry)
mACR70 response: >= 70% improvement in tender and swollen joint count and 70% improvement in two of the following four criteria: 1) participant assessment of pain (scored from 0 mm to 100 mm, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function).
Pfizer
Industry
Characteristics and 6-month Outcomes Among Real-World Rheumatoid Arthritis Patients Initiating Inflectra
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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