Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA)

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the long-term safety and efficacy of repeat treatment courses of rituximab, in combination with methotrexate in a disease-modifying anti-rheumatic drug (DMARD) inadequate responder population of participants who were previously randomized into studies WA16291 (NCT02693210) or WA17043/U2644g (NCT00074438). The study permits multiple re-treatments until the protocol-defined end-of-treatment date (31 December 2011). Participants will then enter a safety follow-up (SFU) period of at least 48 weeks. This will provide at least 7 years follow-up data on all participants initially randomized into WA16291 or WA17043/U2644g. Approximately 600 participants will potentially be eligible to enter this open label extension study from their respective feeder studies.

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

Details

• Lead Sponsor: Hoffmann-La Roche
• Collaborator: Genentech, Inc.
• Treatments: Folic Acid; Methotrexate; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Rituximab

Criteria

Inclusion Criteria:

• participants with active RA

• completed 24 weeks of treatment in WA16291 or WA17043

• eligible for re-treatment, based on clinical symptoms (Disease Activity Score in 28 joints >=2.6)

• females of childbearing potential using reliable contraception

Exclusion Criteria:

• participants who participated in rituximab studies WA16291 or WA17043 but withdrew into the safety follow-up phases of these trials

• previous rituximab non-responders

• current treatment with any other disease-modifying drug (apart from methotrexate), or any anti-tumor necrosis factor alfa, anti-interleukin-1, or other biologic therapies

• participants with known active infection of any kind

• evidence of any new or uncontrolled concomitant disease or development of any new contraindications which would preclude repeat treatment with rituximab

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

• female participants who are pregnant or breastfeeding