Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Percentage of Participants Who Achieved Low Disease Activity (LDA) at 6 Months After Inflectra Initiation |
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. |
6 Months (from the retrospective data collected from the CorEvitas RA registry) |
|
| Secondary |
Percentage of Participants Who Achieved Clinical Remission at 6 Months After Inflectra Initiation |
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. |
6 Months (from the retrospective data collected from the CorEvitas RA registry) |
|
| Secondary |
Change From Baseline in CDAI at 6 Months After Inflectra Initiation |
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. |
Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry) |
|
| Secondary |
Change From Baseline in Health Assessment Questionnaire (HAQ) at 6 Months After Inflectra Initiation |
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. |
Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry) |
|
| Secondary |
Change From Baseline in Participant Pain Assessment at 6 Months After Inflectra Initiation |
Participant pain was measured on a VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). |
Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry) |
|
| Secondary |
Change From Baseline in Participant Fatigue Assessment at 6 Months After Inflectra Initiation |
Participant fatigue was measured on a VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. |
Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry) |
|
| Secondary |
Percentage of Participants With a Modified American College of Rheumatology 20 Percent (%) (mACR20) Response at 6 Months After Inflectra Initiation |
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). |
6 Months (from the retrospective data collected from the CorEvitas RA registry) |
|
| Secondary |
Percentage of Participants With mACR50 at 6 Months After Inflectra Initiation |
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). |
6 Months (from the retrospective data collected from the CorEvitas RA registry) |
|
| Secondary |
Percentage of Participants With mACR70 at 6 Months After Inflectra Initiation |
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). |
6 Months (from the retrospective data collected from the CorEvitas RA registry) |
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