Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis
Status:
Completed
Trial end date:
2019-07-31
Target enrollment:
Participant gender:
Summary
Primary Objective:
To assess the effect of sarilumab in combination with conventional synthetic
Disease-Modifying Anti-Rheumatic Drug (csDMARD) and/or monotherapy on participant-reported
impact of disease, using the rheumatoid arthritis impact of disease (RAID) questionnaire, in
participants with moderately to severely active rheumatoid arthritis (RA) and inadequate
response or intolerance to current csDMARD or tumor necrosis factor (TNF) inhibitors.
Secondary Objectives:
- To assess the change of the RAID score from baseline (to Week 4, Week 12, and Week 24)
in participants with moderately to severely active RA and inadequate response or
intolerance to current csDMARD or TNF inhibitors, treated with sarilumab in combination
with csDMARD and/or monotherapy.
- To assess the effect of sarilumab in combination with csDMARD and/or monotherapy on
other participant-reported outcomes (global assessment of disease activity, disability,
morning stiffness, fatigue, anxiety/depression, mood disorders, and physical activities)
in participants with moderately to severely active RA and inadequate response or
intolerance to current csDMARD or TNF inhibitors.
- To assess the efficacy of sarilumab in combination with csDMARD and/or monotherapy using
disease activity score-28 for RA with erythrocyte sedimentation rate (DAS28-ESR) and
clinical disease activity index in participants with moderately to severely active RA
and inadequate response or intolerance to current csDMARD or TNF inhibitors.
- To assess the safety of sarilumab in combination with csDMARD and/or monotherapy in
participants with moderately to severely active RA and inadequate response or
intolerance to current csDMARD or TNF inhibitors.