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A Randomized, Double-blind, Parallel Group Study of Safety and the Effect on Clinical Outcome of Tocilizumab Subcutaneous (sc) Versus Placebo sc in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis
This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the reduction in disease activity and the safety of tocilizumab (RoActemra/Actemra) in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs) in patients with active, moderate to severe rheumatoid arthritis. In the double-blind part of the study, patients will be randomized to receive either 162 mg tocilizumab or placebo subcutaneously every 2 weeks for 24 weeks using a pre-filled syringe. In the open-label part of the study, patients will be randomized to receive 162 mg tocilizumab subcutaneously every 2 weeks from Week 24 to Week 96 using a pre-filled syringe or an auto-injector.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Peoria, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Fullerton, California, United States
San Diego, California, United States
San Leandro, California, United States
West Hills, California, United States
Trumbull, Connecticut, United States
Boca Raton, Florida, United States
Start Date
March 1, 2011
Primary Completion Date
May 1, 2012
Completion Date
November 1, 2013
Last Updated
July 29, 2015
656
ACTUAL participants
Tocilizumab 162 mg
DRUG
Placebo
DRUG
Lead Sponsor
Hoffmann-La Roche
NCT07484243
NCT06647069
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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