A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment (STAGE)
This study is ongoing, but not recruiting participants.
Sponsor:
Genentech, Inc.
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00406419
First received: November 30, 2006
Last updated: January 6, 2014
Last verified: January 2014
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: methotrexate Drug: ocrelizumab Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
rheumatoid arthritis
MedlinePlus related topics:
Rheumatoid Arthritis
U.S. FDA Resources
Further study details as provided by Genentech, Inc.:
Primary Outcome Measures:
- Percentage of patients with ACR 20 response [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of patients with a major clinical response [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
- The proportion of patients achieving Disease Activity Score (DAS28) remission [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
- Change in DAS28 from baseline [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
- EULAR response rates [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
- Proportion of patients achieving an ACR50 response [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
- Proportion of patients achieving an ACR70 response [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
| Enrollment: | 1015 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | December 2014 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00406419
Please refer to this study by its ClinicalTrials.gov identifier: 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. |
More Information
Additional Information:
No publications provided by Genentech, Inc.
Additional 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 |
| Study First Received: | November 30, 2006 |
| Last Updated: | January 6, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Genentech, Inc.:
|
anti-CD20 stage CD20 RA |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Methotrexate Abortifacient Agents Abortifacient Agents, Nonsteroidal Antimetabolites Antimetabolites, Antineoplastic |
Antineoplastic Agents Antirheumatic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunologic Factors Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Physiological Effects of Drugs Reproductive Control Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 01, 2015