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

Roche

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Rituximab; Drug: Methylprednisolone; Drug: Methotrexate; Drug: Folic Acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT02093026

WA16855

U2653g (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 465 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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465 participants in 1 patient group

Rituximab

Experimental group

Description:

Participants will receive rituximab 1 gram intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants will receive methotrexate 10-25 milligrams per week (mg/week) orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid greater than or equal to (\>=) 5 mg/week or equivalent. Participants will receive retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment will be based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab will be continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever is sooner.

Treatment:

Drug: Methotrexate

Drug: Methylprednisolone

Drug: Folic Acid

Drug: Rituximab