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

This study has been terminated.
(Based on analysis of results and consideration of available treatments, the overall benefit to risk profile of ocrelizumab was not favorable in RA.)
Roche Pharma AG
Information provided by (Responsible Party):
Genentech, Inc. Identifier:
First received: June 11, 2007
Last updated: May 10, 2017
Last verified: May 2017
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.

Condition Intervention Phase
Rheumatoid Arthritis Drug: methotrexate Drug: ocrelizumab Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab in Combination With Methotrexate (MTX) Compared to MTX Alone in Methotrexate- Naive Patients With Active Rheumatoid Arthritis

Resource links provided by NLM:

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Change from baseline in the modified total Sharp score [ Time Frame: Week 52 ]

Secondary Outcome Measures:
  • Health Assessments Questionnaire - Disability Index (HAQ-DI) score [ Time Frame: Week 104 ]
  • Proportion of patients with a major clinical response [ Time Frame: Weeks 52 and 104 ]
  • Proportion of patients achieving Disease Activity Score (DAS28) remission [ Time Frame: Weeks 24, 52, and 104 ]
  • Change in DAS28 from baseline [ Time Frame: Weeks 24, 52, and 104 ]
  • EULAR response rates [ Time Frame: Weeks 24, 52, and 104 ]
  • Proportion of patients achieving an ACR20/ACR50/ACR70/ACR90 response [ Time Frame: Weeks 24, 52, and 104 ]
  • Proportion of patients with a reduction of at least 0.25 units in the HAQ-DI score from baseline [ Time Frame: Weeks 24 and 52 ]

Enrollment: 613
Actual Study Start Date: June 2007
Study Completion Date: August 2013
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: methotrexate
Oral repeating dose
Drug: ocrelizumab
Intravenous repeating dose
Placebo Comparator: 2 Drug: methotrexate
Oral repeating dose
Drug: placebo
Intravenous repeating dose


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 to baseline

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00485589

Sponsors and Collaborators
Genentech, Inc.
Roche Pharma AG
Study Director: Wolfgang Dummer, M.D. Genentech, Inc.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Genentech, Inc. Identifier: NCT00485589     History of Changes
Other Study ID Numbers: ACT3984g
Study First Received: June 11, 2007
Last Updated: May 10, 2017

Keywords provided by Genentech, Inc.:

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors processed this record on September 20, 2017