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A Randomized, Double-blind Study of the Effect of Tocilizumab on Reduction in Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to DMARD Therapy
This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to current DMARD therapy. Patients will be randomized to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Mesa, Arizona, United States
Paradise Valley, Arizona, United States
Peoria, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Los Angeles, California, United States
Palm Desert, California, United States
Palo Alto, California, United States
San Jose, California, United States
Start Date
April 1, 2005
Primary Completion Date
December 1, 2007
Completion Date
December 1, 2007
Last Updated
November 2, 2016
1,220
ACTUAL participants
Placebo
DRUG
tocilizumab [RoActemra/Actemra]
DRUG
Lead Sponsor
Hoffmann-La Roche
NCT06647069
NCT07484243
Data Source & Attribution
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