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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Rheumatoid Arthritis	Drug: methotrexate; Drug: ocrelizumab; Drug: placebo	Phase 3

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Percentage of patients with ACR 20 response [ Time Frame: Weeks 24 and 48 ]

Secondary Outcome Measures :

1. Proportion of patients with a major clinical response [ Time Frame: Week 48 ]
2. The proportion of patients achieving Disease Activity Score (DAS28) remission [ Time Frame: Weeks 24 and 48 ]
3. Change in DAS28 from baseline [ Time Frame: Weeks 24 and 48 ]
4. EULAR response rates [ Time Frame: Weeks 24 and 48 ]
5. Proportion of patients achieving an ACR50 response [ Time Frame: Weeks 24 and 48 ]
6. Proportion of patients achieving an ACR70 response [ Time Frame: Weeks 24 and 48 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	December 4, 2006
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