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

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Rituximab — DRUG
  Participants will receive rituximab 1 gram IV on Days 1 and 15 of each course of retreatment.
• Methotrexate — DRUG
  Participants will receive methotrexate 10-25 mg/week orally or parenterally.
• Methylprednisolone — DRUG
  Participants will receive methylprednisolone 100 mg IV 30 minutes prior to each rituximab infusion.
• Folic Acid — DRUG
  Participants will receive folic acid \>= 5 mg/week or equivalent.

Study Details

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.

Key Dates

Start date

Aug 31, 2002

Status verified

Jan 2017

Primary completion

Dec 31, 2012

Completion

Dec 31, 2012

Study Design

Enrollment

465 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Rituximab
  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.

Primary Outcome Measure

Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response After First Course [ Time Frame: 24 weeks after first course of rituximab (up to approximately 26 weeks) ]

Locations (42)

Find similar trials in Birmingham, AL

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