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.)

Sponsor:

Collaborator:

Roche Pharma AG

Information provided by (Responsible Party):

Genentech, Inc.

ClinicalTrials.gov Identifier:

NCT00406419

First received: November 30, 2006

Last updated: November 17, 2015

Last verified: November 2015

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:

Genetics Home Reference related topics: rheumatoid arthritis

MedlinePlus related topics: Arthritis Rheumatoid Arthritis

Drug Information available for: Methotrexate Methotrexate sodium

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
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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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

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

Emery P, Rigby W, Tak PP, Dörner T, Olech E, Martin C, Millar L, Travers H, Fisheleva E. Safety with ocrelizumab in rheumatoid arthritis: results from the ocrelizumab phase III program. PLoS One. 2014 Feb 3;9(2):e87379. doi: 10.1371/journal.pone.0087379. eCollection 2014.

Rigby W, Tony HP, Oelke K, Combe B, Laster A, von Muhlen CA, Fisheleva E, Martin C, Travers H, Dummer W. Safety and efficacy of ocrelizumab in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a forty-eight-week randomized, double-blind, placebo-controlled, parallel-group phase III trial. Arthritis Rheum. 2012 Feb;64(2):350-9. doi: 10.1002/art.33317.


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:	November 17, 2015
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 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

ClinicalTrials.gov processed this record on September 28, 2016

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