A Study of Tocilizumab and Methotrexate in Combination or as Monotherapy in Treatment-Naïve Patients With Early Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized, double-blind, placebo-controlled study will compare the efficacy with regard to sustained remission and safety of tocilizumab and methotrexate, in combination or as monotherapy, in treatment-naïve patients with early rheumatoid arthritis. Patients will be randomized to receive either tocilizumab (8mg/kg iv every 4 weeks) plus weekly methotrexate (po in ascending doses), or tocilizumab (8mg/kg iv every 4 weeks) plus placebo, or methotrexate plus placebo. Anticipated time on study treatment is 2 years, and target sample size is 300.

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

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• adult patients, >/=18 years of age

• early rheumatoid arthritis (disease symptoms <1 year) according to ACR criteria

• disease activity DAS28 >2.6

• body weight Exclusion Criteria:

• rheumatic autoimmune disease other than RA

• current inflammatory joint disease other than RA

• previous treatment with any DMARD or biologic drug used in the treatment of RA

• intra-articular, parenteral or oral glucocorticoids used for the arthritis