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A Randomized, Double-blind, Parallel Group Study of the Safety and Effect on Clinical Outcome of Tocilizumab SC Versus Tocilizumab IV, in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Active Rheumatoid Arthritis
This randomized, double-blind, parallel group study compares the efficacy and safety of subcutaneous (sc) versus intravenous (iv) administration of tocilizumab in participants with moderate to severe active rheumatoid arthritis. Participants were randomized to receive either tocilizumab 162 mg sc weekly plus iv placebo every 4 weeks, or tocilizumab 8 mg/kg iv every 4 weeks plus sc placebo weekly during the double-blind period from baseline to Week 24. The double-blind period was followed by a 72-week open-label treatment with some switching of sc and iv administration. No placebo was administered in the open-label phase. Participants continued on their stable dose of disease-modifying antirheumatic drugs (DMARDs) throughout the study. Anticipated time on study treatment was 2 years.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Huntsville, Alabama, United States
Tuscaloosa, Alabama, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Long Beach, California, United States
Los Angeles, California, United States
Upland, California, United States
Van Nuys, California, United States
Denver, Colorado, United States
Bridgeport, Connecticut, United States
Start Date
September 1, 2010
Primary Completion Date
January 1, 2012
Completion Date
August 1, 2013
Last Updated
June 20, 2016
1,262
ACTUAL participants
tocilizumab SC
DRUG
tocilizumab IV
DRUG
placebo to tocilizumab SC
DRUG
placebo to tocilizumab IV
DRUG
Disease-modifying antirheumatic drugs (DMARDs)
DRUG
Lead Sponsor
Hoffmann-La Roche
NCT07484243
NCT06647069
Data Source & Attribution
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