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A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment (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.)
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00406419
First received: November 30, 2006
Last updated: June 25, 2010
Last verified: June 2010
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Genentech:

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 ]

Estimated Enrollment: 1000
Study Start Date: December 2006
Estimated Primary Completion Date: June 2010 (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
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
Roche Pharma AG
Investigators
Study Director: Wolfgang Dummer, M.D. Genentech
  More Information

Additional Information:
Ex-U.S. Study Information (Ex-US this trial is sponsored/managed by Hoffmann-La Roche)  This link exits the ClinicalTrials.gov site

No publications provided by Genentech

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00406419     History of Changes
Other Study ID Numbers: ACT3985g, WA20494
Study First Received: November 30, 2006
Last Updated: June 25, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
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
 Pharmacologic Actions
Therapeutic Uses
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

ClinicalTrials.gov processed this record on May 23, 2013