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
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).
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Percentage of participants who achieve 20% improvement from baseline according to the American College of Rheumatology core set disease activity index [ACR20]
12 weeks
No
Clinical Sciences & Operations
Study Director
Sanofi
United States: Food and Drug Administration
ACT11575
NCT01217814
November 2010
September 2011
Name | Location |
---|---|
Investigational Site Number 840026 | Freehold, New Jersey 07728 |
Investigational Site Number 840043 | New York, New York 11201 |
Investigational Site Number 840025 | Jackson, Tennessee 38305 |
Investigational Site Number 840038 | Austin, Texas 78705 |