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

This study has been terminated.
(Based on analysis of results and consideration of available treatments, the overall benefit to risk profile of ocrelizumab was not favorable in RA.)
Roche Pharma AG
Information provided by (Responsible Party):
Genentech, Inc. Identifier:
First received: November 30, 2006
Last updated: November 17, 2015
Last verified: November 2015
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 (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

Resource links provided by NLM:

Further study details as provided by Genentech, Inc.:

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 ]

Enrollment: 1015
Study Start Date: December 2006
Study Completion Date: April 2015
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


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)
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Please refer to this study by its identifier: NCT00406419

United States, California
Trial Information Support Line
South San Francisco, California, United States, 94080
Sponsors and Collaborators
Genentech, Inc.
Roche Pharma AG
Study Director: Wolfgang Dummer, M.D. Genentech, Inc.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Genentech, Inc. Identifier: NCT00406419     History of Changes
Other Study ID Numbers: ACT3985g
Study First Received: November 30, 2006
Last Updated: November 17, 2015

Keywords provided by Genentech, Inc.:

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors processed this record on April 27, 2017