A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis

Completed · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

This 2-arm study assessed the safety and efficacy of tocilizumab versus placebo, both in combination with disease modifying antirheumatic drugs (DMARDs), in regard to reduction in signs and symptoms, in patients with moderate to severe active rheumatoid arthritis with an inadequate response to DMARDs. Patients were randomized in a ratio of 2:1 to receive either tocilizumab 8 mg/kg intravenously (IV) or placebo IV every 4 weeks. All patients also received stable antirheumatic therapy, including permitted DMARDs. The anticipated time on study treatment was 3-12 months and the target sample size was 500+ individuals.

Key facts

Study ID

NCT00531817

Run by

Hoffmann-La Roche

People needed

619

Starts

2007-10-01

Expected to finish

2011-03-01

Last updated by the study team

2012-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients, ≥18 years of age
• Active rheumatoid arthritis of >6 months duration
• Received permitted DMARDs each at a stable dose for at least 7 weeks prior to baseline

You may not qualify if…

• Rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis
• Major surgery within 8 weeks prior to screening or planned within 6 months following randomization
• Unsuccessful treatment with a biologic agent, including an anti-TNF agent
• Previous treatment with tocilizumab

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Birmingham, Alabama, United States
• Study site — Montgomery, Alabama, United States
• Study site — Lake Havasu City, Arizona, United States
• Study site — Paradise Valley, Arizona, United States
• Study site — Peoria, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — Beverly Hills, California, United States
• Study site — Escondido, California, United States
• Study site — La Jolla, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Pasadena, California, United States
• Study site — Santa Maria, California, United States
• Study site — Santa Monica, California, United States
• Study site — Upland, California, United States
• Study site — Van Nuys, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Whittier, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Trumbull, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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