Rheumatoid Arthritis Clinical Trial
Official title:
A Randomized, Double-blind, Parallel-group, Placebo- and Active Calibrator-controlled Study Assessing the Clinical Benefit of SAR153191 Subcutaneous (SC) on Top of Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis (RA) Who Have Failed Previous TNF-α Antagonists
Primary Objective:
- Demonstrate that sarilumab (SAR153191/REGN88) on top of methotrexate [MTX] is superior in
efficacy to placebo for the relief of signs and symptoms of Rheumatoid Arthritis [RA], in
patients with active RA who have failed up to 2 Tumor Necrosis Factor α [TNF-α] antagonists.
Secondary Objectives:
- Assess the safety of sarilumab;
- Document the pharmacokinetic profile of sarilumab.
The duration of the study period for each participant was approximately 22 weeks; including
up to 4 weeks screening period, 12-week double-blind treatment period and 6-week safety
follow-up period.
Participants who completed the 12-week treatment period were offered enrollment in a
separate long-term extension study (LTS11210/NCT01146652).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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