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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00485589
Recruitment Status : Terminated (Based on analysis of results and consideration of available treatments, the overall benefit to risk profile of ocrelizumab was not favorable in RA.)
First Posted : June 13, 2007
Last Update Posted : May 11, 2017
Roche Pharma AG
Information provided by (Responsible Party):
Genentech, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: methotrexate Drug: ocrelizumab Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 613 participants
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
Actual Study Start Date : June 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. Health Assessments Questionnaire - Disability Index (HAQ-DI) score [ Time Frame: Week 104 ]
  2. Proportion of patients with a major clinical response [ Time Frame: Weeks 52 and 104 ]
  3. Proportion of patients achieving Disease Activity Score (DAS28) remission [ Time Frame: Weeks 24, 52, and 104 ]
  4. Change in DAS28 from baseline [ Time Frame: Weeks 24, 52, and 104 ]
  5. EULAR response rates [ Time Frame: Weeks 24, 52, and 104 ]
  6. Proportion of patients achieving an ACR20/ACR50/ACR70/ACR90 response [ Time Frame: Weeks 24, 52, and 104 ]
  7. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00485589

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Genentech, Inc. Identifier: NCT00485589     History of Changes
Other Study ID Numbers: ACT3984g
First Posted: June 13, 2007    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017
Keywords provided by Genentech, Inc.:
Additional relevant MeSH terms:
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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