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A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate (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.)
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00485589
First received: June 11, 2007
Last updated: June 25, 2010
Last verified: June 2010
History of Changes
  Purpose

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 Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Change from baseline in the modified total Sharp score [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health Assessments Questionnaire - Disability Index (HAQ-DI) score [ Time Frame: Week 104 ] [ Designated as safety issue: No ]
  • Proportion of patients with a major clinical response [ Time Frame: Weeks 52 and 104 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving Disease Activity Score (DAS28) remission [ Time Frame: Weeks 24, 52, and 104 ] [ Designated as safety issue: No ]
  • Change in DAS28 from baseline [ Time Frame: Weeks 24, 52, and 104 ] [ Designated as safety issue: No ]
  • EULAR response rates [ Time Frame: Weeks 24, 52, and 104 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving an ACR20/ACR50/ACR70/ACR90 response [ Time Frame: Weeks 24, 52, and 104 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: June 2007
Estimated Primary Completion Date: December 2011 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00485589

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

Additional Information:
Ex-U.S. Study Information (Ex-US this trial is sponsored/managed by Hoffmann-La Roche)  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00485589     History of Changes
Other Study ID Numbers: ACT3984g, WA20497
Study First Received: June 11, 2007
Last Updated: June 25, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
FILM
RA
anti-CD20
CD20

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013