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A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab

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ClinicalTrials.gov Identifier: NCT00808210
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 15, 2008
Results First Posted : November 6, 2020
Last Update Posted : November 6, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This is a Phase II, randomized, active-controlled, double-blind, double-dummy, parallel-group, multicenter study in the United States enrolling patients with active RA. The study will enroll approximately 290 patients at approximately 130 sites.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Infliximab Drug: Methotrexate Drug: Methylprednisolone Drug: Ocrelizumab Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A PHASE II RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN COMBINATION WITH METHOTREXATE, COMPARED TO INFLIXIMAB PLUS METHOTREXATE IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS CURRENTLY RESPONDING INADEQUATELY TO ETANERCEPT OR ADALIMUMAB
Actual Study Start Date : March 5, 2009
Actual Primary Completion Date : November 14, 2012
Actual Study Completion Date : November 14, 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ocrelizumab 200mg
Participants received two intravenous (IV) infusions of 200 mg ocrelizumab administered on Day 1 and Day 15 and placebo IV infliximab infusions administered on Day 1, Day 15, Week 6, and Week 14. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
Drug: Methotrexate
Oral or parenteral repeating dose

Drug: Methylprednisolone
Intravenous repeating dose

Drug: Ocrelizumab
Intravenous repeating dose

Drug: Placebo
Intravenous repeating dose

Active Comparator: Infliximab 5mg/kg
Participants received four IV infusions of 5 mg/kg infliximab administered on Day 1, Day 15, Week 6, and Week 14 and placebo ocrelizumab infusions administered on Day 1 and Day 15. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
Drug: Infliximab
Intravenous repeating dose

Drug: Methotrexate
Oral or parenteral repeating dose

Drug: Methylprednisolone
Intravenous repeating dose

Drug: Placebo
Intravenous repeating dose




Primary Outcome Measures :
  1. Change From Baseline in DAS28(ESR) at Week 20 [ Time Frame: Week 20 ]

Secondary Outcome Measures :
  1. Percentage of Participants With Clinical Response of 20% According to ACR Criteria [ Time Frame: Baseline up to 30 months ]
  2. Percentage of Participants With Clinical Response of 50% According to ACR Criteria [ Time Frame: Baseline up to 30 months ]
  3. Percentage of Participants With Clinical Response of 70% According to ACR Criteria [ Time Frame: Baseline up to 30 months ]
  4. European League Against Rheumatism (EULAR) Response Rates [ Time Frame: Baseline up to 30 months ]
  5. Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score [ Time Frame: Baseline up to 30 months ]
  6. Change in Fatigue Visual Analog Scale Score (VAS) [ Time Frame: Baseline up to 30 months ]
  7. Percentage of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to 30 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >= 18 years
  • Current treatment for RA on an outpatient basis
  • Active disease
  • Currently receiving 50 mg etanercept subcutaneously (SC) every week or 40 mg adalimumab SC every other week.
  • Considered by Investigator to be a primary non-responder to their first anti-TNFα treatment for efficacy reasons

Exclusion Criteria:

  • Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
  • History of, or current, inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or other overlap syndrome)
  • Previous treatment with a any biologic therapy for RA (including investigational products with the exception of etanercept or adalimumab
  • Treatment with more than one prior anti-TNFα therapy

Information from the National Library of Medicine

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): NCT00808210


Locations
Show Show 53 study locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Genentech, Inc.
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00808210    
Other Study ID Numbers: ACT4562g
GA00931
First Posted: December 15, 2008    Key Record Dates
Results First Posted: November 6, 2020
Last Update Posted: November 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Keywords provided by Genentech, Inc.:
RA
Arthritis
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methylprednisolone
Methotrexate
Infliximab
Ocrelizumab
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
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents