A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate (FILM)

Last updated: October 11, 2020
Sponsor: Genentech, Inc.
Overall Status: Terminated

Phase

3

Condition

Rheumatoid Arthritis

Joint Injuries

Dermatomyositis (Connective Tissue Disease)

Treatment

N/A

Clinical Study ID

NCT00485589
ACT3984g
WA20497
  • Ages > 18
  • All Genders

Study Summary

This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in combination with methotrexate in patients with active rheumatoid arthritis who are naive to methotrexate. Patients will be randomized to receive placebo, ocrelizumab 200mg i.v. or ocrelizumab 500mg i.v. on Days 1 and 15. Repeat courses of i.v. treatment will be administered at weeks 24, 52 and 76. All patients will receive concomitant methotrexate (7.5 mg escalating to 20mg p.o. weekly). The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Age ≥ 18
  • Rheumatoid arthritis for 3 months-5 years
  • Naive to methotrexate
  • If receiving steroids or NSAIDs, must be on a stable dose for 4 weeks prior tobaseline

Exclusion

Exclusion criteria:

  • Rheumatic autoimmune disease or inflammatory joint disease other than RA
  • Prior receipt of any biologic therapy for RA
  • Concurrent treatment with any DMARD

Study Design

Total Participants: 613
Study Start date:
June 11, 2007
Estimated Completion Date:
August 29, 2013