A Study to Evaluate Ocrelizumab Compared With Placebo in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy

NCT ID: NCT00673920

Last Updated: 2020-12-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 314 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-24
• Study Completion Date: 2009-10-26

Brief Summary

This study will evaluate the efficacy and safety of ocrelizumab, compared to placebo, in patients with active rheumatoid arthritis who have an inadequate response to methotrexate therapy. Patients will be randomized 2:2:1 to receive 1) infusions of ocrelizumab 200mg iv on Days 1 and 15, 2) infusions of ocrelizumab 400mg iv on Day 1 and placebo iv on Day 15, or 3) infusions of placebo iv on Days 1 and 15. At the end of the placebo-controlled treatment period at 24 weeks, patients in groups 1 and 3 will be re-randomized to receive either a single infusion of 400mg iv ocrelizumab or 2 infusions of 200mg iv ocrelizumab, and group 2 will receive a second single infusion of 400mg iv ocrelizumab. All patients will receive a stable dose of concomitant methotrexate (7.5-25mg/week) throughout the study. The anticipated time on study treatment is 1-2 years. Target number of patients to be enrolled in this trial is 300.

Conditions

Rheumatoid Arthritis

Keywords

RA

Study Design

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

Study Groups

Placebo

Participants received matching placebo:

• on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)
• on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)

Group Type: PLACEBO_COMPARATOR

Methotrexate

Intervention Type: DRUG

Oral or parenteral repeating dose

Placebo

Intervention Type: DRUG

Intravenous repeating dose

Ocrelizumab 400mg

Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.

Group Type: EXPERIMENTAL

Methotrexate

Intervention Type: DRUG

Oral or parenteral repeating dose

Ocrelizumab

Intervention Type: DRUG

Ocrelizumab was administered as a slow intravenous (iv) infusion during each course as either 200 mg on Day 1 and Day 15 (OCR 200×2) or as 400 mg given on Day 1 (OCR 400×1).

Ocrelizumab was administered in combination with Methotrexate.

Ocrelizumab 200mg

Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.

Group Type: EXPERIMENTAL

Methotrexate

Intervention Type: DRUG

Oral or parenteral repeating dose

Ocrelizumab

Intervention Type: DRUG

Ocrelizumab was administered as a slow intravenous (iv) infusion during each course as either 200 mg on Day 1 and Day 15 (OCR 200×2) or as 400 mg given on Day 1 (OCR 400×1).

Ocrelizumab was administered in combination with Methotrexate.

Ocrelizumab 200mg/ Ocrelizumab 200mg

Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2

Group Type: EXPERIMENTAL

Methotrexate

Intervention Type: DRUG

Oral or parenteral repeating dose

Ocrelizumab

Intervention Type: DRUG

Ocrelizumab was administered as a slow intravenous (iv) infusion during each course as either 200 mg on Day 1 and Day 15 (OCR 200×2) or as 400 mg given on Day 1 (OCR 400×1).

Ocrelizumab was administered in combination with Methotrexate.

Ocrelizumab 200mg/ Ocrelizumab 400mg

Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2

Group Type: EXPERIMENTAL

Methotrexate

Intervention Type: DRUG

Oral or parenteral repeating dose

Ocrelizumab

Intervention Type: DRUG

Ocrelizumab was administered as a slow intravenous (iv) infusion during each course as either 200 mg on Day 1 and Day 15 (OCR 200×2) or as 400 mg given on Day 1 (OCR 400×1).

Ocrelizumab was administered in combination with Methotrexate.

Ocrelizumab 400mg/ Ocrelizumab 400mg

Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2

Group Type: EXPERIMENTAL

Methotrexate

Intervention Type: DRUG

Oral or parenteral repeating dose

Ocrelizumab

Intervention Type: DRUG

Ocrelizumab was administered as a slow intravenous (iv) infusion during each course as either 200 mg on Day 1 and Day 15 (OCR 200×2) or as 400 mg given on Day 1 (OCR 400×1).

Ocrelizumab was administered in combination with Methotrexate.

Placebo/ Ocrelizumab 200mg

Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2

Group Type: EXPERIMENTAL

Methotrexate

Intervention Type: DRUG

Oral or parenteral repeating dose

Ocrelizumab

Intervention Type: DRUG

Ocrelizumab was administered as a slow intravenous (iv) infusion during each course as either 200 mg on Day 1 and Day 15 (OCR 200×2) or as 400 mg given on Day 1 (OCR 400×1).

Ocrelizumab was administered in combination with Methotrexate.

Placebo

Intervention Type: DRUG

Intravenous repeating dose

Placebo/ Ocrelizumab 400mg

Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2

Group Type: EXPERIMENTAL

Methotrexate

Intervention Type: DRUG

Oral or parenteral repeating dose

Ocrelizumab

Intervention Type: DRUG

Ocrelizumab was administered as a slow intravenous (iv) infusion during each course as either 200 mg on Day 1 and Day 15 (OCR 200×2) or as 400 mg given on Day 1 (OCR 400×1).

Ocrelizumab was administered in combination with Methotrexate.

Placebo

Intervention Type: DRUG

Intravenous repeating dose

Interventions

Methotrexate

Oral or parenteral repeating dose

Intervention Type: DRUG

Ocrelizumab

Ocrelizumab was administered as a slow intravenous (iv) infusion during each course as either 200 mg on Day 1 and Day 15 (OCR 200×2) or as 400 mg given on Day 1 (OCR 400×1).

Ocrelizumab was administered in combination with Methotrexate.

Intervention Type: DRUG

Placebo

Intravenous repeating dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult patients, ≥ 18 years of age
• Active rheumatoid arthritis
• Inadequate treatment with any DMARD other than methotrexate

Exclusion Criteria

• Rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis
• Concurrent treatment with any DMARD other than methotrexate
• Previous treatment with any cell-depleting therapies
• Any surgical procedure in past 12 weeks, or planned within 48 weeks after baseline

• 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.

Countries

United States

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

WA20496

Identifier Type: -

Identifier Source: secondary_id

ACT4394g

Identifier Type: -

Identifier Source: org_study_id