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

NCT ID: NCT00485589

Last Updated: 2020-11-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 613 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-11
• Study Completion Date: 2013-08-29

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Intravenous repeating dose

Ocrelizumab 200 mg

Participants received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.

Group Type: EXPERIMENTAL

Methotrexate

Intervention Type: DRUG

Oral repeating dose

Ocrelizumab

Intervention Type: DRUG

Intravenous repeating dose

Ocrelizumab 500 mg

Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.

Group Type: EXPERIMENTAL

Methotrexate

Intervention Type: DRUG

Oral repeating dose

Ocrelizumab

Intervention Type: DRUG

Intravenous repeating dose

Interventions

Methotrexate

Oral repeating dose

Intervention Type: DRUG

Ocrelizumab

Intravenous repeating dose

Intervention Type: DRUG

Placebo

Intravenous repeating dose

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wolfgang Dummer, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

References

Emery P, Rigby W, Tak PP, Dorner 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.

Reference Type: DERIVED

PMID: 24498318 (View on PubMed)

Other Identifiers

WA20497

Identifier Type: -

Identifier Source: secondary_id

ACT3984g

Identifier Type: -

Identifier Source: org_study_id