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

Roche

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: Tocilizumab; Drug: Permitted DMARDs

Study type: Interventional

Funder types: Industry

Identifiers

NCT00531817

ML21136

Details and patient eligibility

About

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.

Enrollment: 619 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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619 participants in 2 patient groups, including a placebo group

Tocilizumab 8 mg/kg + DMARDs

Experimental group

Treatment:

Drug: Tocilizumab

Drug: Permitted DMARDs

Placebo + DMARDs

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Permitted DMARDs