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 |
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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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 |

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
|
- Percentage of patients with ACR 20 response [ Time Frame: Weeks 24 and 48 ]
- 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, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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
United States, California | |
Trial Information Support Line | |
South San Francisco, California, United States, 94080 |
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.:
anti-CD20 stage CD20 RA |
Additional relevant MeSH terms:
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 |