A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment (STAGE) (STAGE)
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| ClinicalTrials.gov Identifier: NCT00406419 |
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Recruitment Status :
Terminated
(Based on analysis of results and consideration of available treatments, the overall benefit to risk profile of ocrelizumab was not favorable in RA.)
First Posted : December 4, 2006
Last Update Posted : May 15, 2017
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Sponsor:
Genentech, Inc.
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Genentech, Inc.
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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 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Rheumatoid Arthritis | Drug: methotrexate Drug: ocrelizumab Drug: placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1015 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment |
| Actual Study Start Date : | December 2006 |
| Actual Primary Completion Date : | October 2009 |
| Actual Study Completion Date : | April 2015 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Rheumatoid arthritis
| Arm | Intervention/treatment |
|---|---|
| Experimental: 1 |
Drug: methotrexate
Oral repeating dose Drug: ocrelizumab Intravenous repeating dose (200mg) |
| Experimental: 2 |
Drug: methotrexate
Oral repeating dose Drug: ocrelizumab Intravenous repeating dose (500mg) |
| Placebo Comparator: 3 |
Drug: methotrexate
Oral repeating dose Drug: placebo Intravenous repeating dose |
Primary Outcome Measures :
- Percentage of patients with ACR 20 response [ Time Frame: Weeks 24 and 48 ]
Secondary Outcome Measures :
- Proportion of patients with a major clinical response [ Time Frame: Week 48 ]
- The proportion of patients achieving Disease Activity Score (DAS28) remission [ Time Frame: Weeks 24 and 48 ]
- Change in DAS28 from baseline [ Time Frame: Weeks 24 and 48 ]
- EULAR response rates [ Time Frame: Weeks 24 and 48 ]
- Proportion of patients achieving an ACR50 response [ Time Frame: Weeks 24 and 48 ]
- Proportion of patients achieving an ACR70 response [ Time Frame: Weeks 24 and 48 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00406419
Locations
| United States, California | |
| Trial Information Support Line | |
| South San Francisco, California, United States, 94080 | |
Sponsors and Collaborators
Genentech, Inc.
Roche Pharma AG
Investigators
| Study Director: | Wolfgang Dummer, M.D. | Genentech, Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Genentech, Inc. |
| ClinicalTrials.gov Identifier: | NCT00406419 History of Changes |
| Other Study ID Numbers: |
ACT3985g WA20494 |
| First Posted: | December 4, 2006 Key Record Dates |
| Last Update Posted: | May 15, 2017 |
| Last Verified: | May 2017 |
Keywords provided by Genentech, Inc.:
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anti-CD20 stage CD20 RA |
Additional relevant MeSH terms:
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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 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 |