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A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment (STAGE)

NCT ID: NCT00406419

Last Updated: 2020-11-27

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1015 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-27

Study Completion Date

2015-04-22

Brief Summary

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This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in combination with methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients will be randomized to receive placebo, 200mg of intravenous ocrelizumab or 500mg of i.v. ocrelizumab on Days 1 and 15. A repeat course of i.v. treatment will be administered at Weeks 24 and 26. All patients will receive 7.5mg - 25mg/week concomitant methotrexate at a stable dose. The anticipated time on study treatment is 1-2 years. Target sample size is 1000.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Keywords

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anti-CD20 stage CD20 RA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo × 2 IV + MTX

Participants received two intravenous (IV) infusion matching placebo to ocrelizumab on Day 1 and Day 15. A repeat course was administered at Weeks 24 and 26. Methotrexate 7.5-25 milligram (mg) was administered weekly.

Group Type PLACEBO_COMPARATOR

Methotrexate

Intervention Type DRUG

Methotrexate tablet was administered orally at a dose 7.5-25 mg

Placebo

Intervention Type DRUG

Matching placebo to ocrelizumab was administered via IV infusion

Ocrelizumab 200 mg × 2 IV + MTX

Participants received two IV infusion of ocrelizumab 200 mg on Day 1 and Day 15. A repeat course was administered at Weeks 24 and 26. Methotrexate 7.5-25 mg was administered weekly.

Group Type EXPERIMENTAL

Methotrexate

Intervention Type DRUG

Methotrexate tablet was administered orally at a dose 7.5-25 mg

ocrelizumab

Intervention Type DRUG

Ocrelizumab was administered via IV infusion at a dose specified in arm description

Ocrelizumab 500 mg × 2 IV + MTX

Participants received two IV infusion of ocrelizumab 500 mg on Day 1 and Day 15. A repeat course was administered at Weeks 24 and 26. Methotrexate 7.5-25 mg was administered weekly.

Group Type PLACEBO_COMPARATOR

Methotrexate

Intervention Type DRUG

Methotrexate tablet was administered orally at a dose 7.5-25 mg

ocrelizumab

Intervention Type DRUG

Ocrelizumab was administered via IV infusion at a dose specified in arm description

Interventions

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Methotrexate

Methotrexate tablet was administered orally at a dose 7.5-25 mg

Intervention Type DRUG

ocrelizumab

Ocrelizumab was administered via IV infusion at a dose specified in arm description

Intervention Type DRUG

Placebo

Matching placebo to ocrelizumab was administered via IV infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients, ≥18 years of age
* Rheumatoid arthritis for ≥ 3 months
* Inadequate clinical response to methotrexate at a dose of 7.5-25mg/week for ≥ 12 weeks

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 (other than methotrexate)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roche Pharma AG

INDUSTRY

Sponsor Role collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wolfgang Dummer, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

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Trial Information Support Line

South San Francisco, California, United States

Site Status

Countries

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United States

References

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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)

Rigby W, Tony HP, Oelke K, Combe B, Laster A, von Muhlen CA, Fisheleva E, Martin C, Travers H, Dummer W. Safety and efficacy of ocrelizumab in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a forty-eight-week randomized, double-blind, placebo-controlled, parallel-group phase III trial. Arthritis Rheum. 2012 Feb;64(2):350-9. doi: 10.1002/art.33317.

Reference Type DERIVED
PMID: 21905001 (View on PubMed)

Other Identifiers

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WA20494

Identifier Type: -

Identifier Source: secondary_id

ACT3985g

Identifier Type: -

Identifier Source: org_study_id