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 (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00485589
First received: June 11, 2007
Last updated: June 28, 2013
Last verified: June 2013

June 11, 2007
June 28, 2013
June 2007
April 2011   (final data collection date for primary outcome measure)
Change from baseline in the modified total Sharp score [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Modified Sharp score of hand and feet radiographs
Complete list of historical versions of study NCT00485589 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Health Assessments Questionnaire - Disability Index (HAQ-DI) score
  • SF-36 and FACIT Fatigue Scale scores
  • Modified Brief Pain Inventory (BPI), disease status and activity limitation questions on the eCRF
  • Percentage of patients with clinical response of 20%, 50%, and 70% according to ACR criteria (ACR20, ACR50, and ACR70) and the components of this outcome
  • Disease activity scores (DAS28)
  • European League Against Rheumatism (EULAR) response rates
  • Incidence of adverse events graded according to the NCI CTC AE (Version 3.0)
  • Incidence of clinical laboratory abnormalities
  • Incidence of human anti-ocrelizumab antibodies (HAHA)
Not Provided
Not Provided
 
A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate (FILM)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: methotrexate
    Oral repeating dose
  • Drug: ocrelizumab
    Intravenous repeating dose
  • Drug: placebo
    Intravenous repeating dose
  • Experimental: 1
    Interventions:
    • Drug: methotrexate
    • Drug: ocrelizumab
  • Placebo Comparator: 2
    Interventions:
    • Drug: methotrexate
    • Drug: placebo
Emery P, Rigby W, Tak PP, Dörner T, Olech E, Martin C, Millar L, Travers H, Fisheleva E. Safety with ocrelizumab in rheumatoid arthritis: results from the ocrelizumab phase III program. PLoS One. 2014 Feb 3;9(2):e87379. doi: 10.1371/journal.pone.0087379. eCollection 2014.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
613
Not Provided
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00485589
ACT3984g, WA20497
Not Provided
Genentech
Genentech
Roche Pharma AG
Study Director: Wolfgang Dummer, M.D. Genentech
Genentech
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP