A Study of Tocilizumab and Methotrexate Treatment Strategies (Adding Tocilizumab to Methotrexate Versus Switching to Tocilizumab) in Patients With Active Rheumatoid Arthritis With Inadequate Response to Prior Methotrexate Treatment

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This 2 arm study will compare 2 treatment strategies based on tocilizumab in combination with methotrexate or placebo in patients with moderate to severe rheumatoid arthritis. Patients receiving methotrexate treatment will be randomized to receive either a) tocilizumab 8 mg intravenous (iv) every 4 weeks + methotrexate orally (po) weekly or b) tocilizumab 8 mg iv every 4 weeks + placebo po weekly. After the first 24 weeks of blinded treatment, treatment adjustments (increase or decrease of treatment intensity) may be introduced at intervals, based on response. The anticipated time on study treatment is up to 3 years, and the target sample size is approximately 470 patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Antirheumatic Agents; Methotrexate

Criteria

Inclusion Criteria:

• adult patients, ≥ 18 years of age;

• moderate to severe active rheumatoid arthritis (Disease Activity Score (DAS28) > 4.4);

• inadequate response to methotrexate;

• on a stable dose of ≥ 15mg/week methotrexate for at least 6 weeks.

Exclusion Criteria:

• prior treatment with a biologic;

• Rheumatoid arthritis (RA) functional class IV;

• known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections;

• evidence of active malignant disease.