A Study of Combination Treatment With MabThera (Rituximab) and RoActemra (Tocilizumab) Versus RoActemra in Patients With Rheumatoid Arthritis With an Incomplete Response to Methotrexate

• Status: Terminated
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This 2 part study will investigate the safety, tolerability and efficacy of MabT hera in combination with RoActemra in patients with active rheumatoid arthritis despite a stable dose of methotrexate. In Part 1 of the study, patients will be randomized to receive either MabThera 0.5g iv or placebo on days 1 and 15, follo wed by RoActemra at one of the ascending doses between 2mg/kg and 8mg/kg at week s 4, 8 and 12 (MabThera arm) or 8mg/kg (placebo arm). In Part 2, additional pati ents will be randomized to one of 2 groups to receive MabThera 0.5g on days 1 an d 15 followed by the selected dose (from Part 1)of RoActemra at weeks 4, 8 and 1 2, or placebo on days 1 and 15 followed by RoActemra 8mg/kg at weeks 4,8 and 12.

All patients will then be eligible to receive extension treatment withRoActemra every 4 weeks. The anticipated time on study treatment is 12 months, and the tar get sample size is <100 individuals.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• adult patients, 18-65 years of age;

• rheumatoid arthritis, functional status I-III;

• SJC>=4 (28 joint count) and TJC>=4 (28 joint count) at screening and baseline;

• RF and/or anti-CCP positive;

• may have failed up to 1 approved anti-TNF agent (infliximab, etanercept or adalimumab);

• inadequate response to methotrexate, at a dose of 7.5-25mg weekly for at least 12 weeks, at a stable dose for past 4 weeks.

Exclusion Criteria:

• rheumatic autoimmune disease other than rheumatoid arthritis, or significant systemic involvement secondary to rheumatoid arthritis;

• history of, or current, inflammatory joint disease other than rheumatoid arthritis;

• diagnosis of juvenile idiopathic arthritis and/or rheumatoid arthritis before age 16;

• significant cardiac or pulmonary disease;

• previous treatment with any biologic agent for rheumatoid arthritis (other than infliximab, etanercept or adalimumab).