A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety and efficacy of rituximab combined with MTX in participants with active rheumatoid arthritis (RA) who have had an inadequate response to anti-Tumor Necrosis (TNF) alpha therapy. The anticipated time in the study is up to 2 years and the target sample size is 500 participants. Eligible participants may receive re-treatment with rituximab under a separate protocol WA17531.

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

Details

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

Criteria

Inclusion Criteria:

• Adult participants 18-80 years of age with active RA for at least 6 months;

• Received treatment for RA on an outpatient basis and experienced an inadequate response or intolerance to treatment with at least 1 anti-TNF alpha therapy (etanercept, infliximab or adalimumab);

• Must have received MTX for a minimum of 12 weeks, with the last 4 weeks, prior to screening at a stable dose;

• Participants with swollen joint count (SJC) and tender joint count (TJC) of at least 8 joints at screening and at randomization;

• Radiographic evidence of at least 1 joint with a definite erosion due to RA;

• Participants of reproductive potential must be using reliable contraceptive methods.

Exclusion Criteria:

• Bone or joint surgery within 8 weeks prior to screening or joint surgery planned within 24 weeks of randomization;

• Class IV functional status of RA;

• Previous treatment within 6 months with intravenous gamma globulin, or the Prosorba column;

• Intraarticular or parenteral corticosteroids within 4 weeks prior to screening visit;

• With a live vaccine within 4 weeks prior to randomization;

• Previous treatment with rituximab or other cell-depleting therapies;

• Concurrent treatment with any disease-modifying anti-rheumatic drug (except for MTX) or any anti-TNF alfa factor or other biologic therapy;

• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies;

• Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders;

• Known contraindications to receiving rituximab;

• Known active bacterial, viral, fungal, mycobacterial or other infection;

• History of recurrent significant infection or history of recurrent bacterial infections;

• Primary or secondary immunodeficiency (history of, or currently active);

• History of cancer, including solid tumors and hematologic malignancies (except basal cell or squamous cell carcinoma of the skin that have been excised and cured);

• Women who are pregnant or breast-feeding;

• History of alcohol, drug or chemical abuse within 6 months prior to screening;

• Neuropathies and neurovasculopathies which might interfere with pain evaluation;

• Participants with poor peripheral venous access;

• Intolerance or contraindications to oral or intravenous corticosteroids.