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

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:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00808210
First received: December 11, 2008
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
Rheumatoid Arthritis
Drug: infliximab
Drug: methotrexate
Drug: methylprednisolone
Drug: ocrelizumab
Drug: sham
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Difference between treatment groups in the mean change from baseline in DAS28(ESR) [ Time Frame: Week 20 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with clinical response of 20%, 50%, and 70% according to ACR criteria (i.e., ACR20, ACR50, and ACR70) [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • European League Against Rheumatism (EULAR) response rates [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) score [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: March 2009
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: methotrexate
Oral or parenteral repeating dose
Drug: methylprednisolone
Intravenous repeating dose
Drug: ocrelizumab
Intravenous repeating dose
Drug: sham
Intravenous repeating dose
Active Comparator: B Drug: infliximab
Intravenous repeating dose
Drug: methotrexate
Oral or parenteral repeating dose
Drug: methylprednisolone
Intravenous repeating dose
Drug: sham
Intravenous repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: NCT00808210

  Show 129 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00808210     History of Changes
Other Study ID Numbers: ACT4562g, GA00931
Study First Received: December 11, 2008
Last Updated: September 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
RA
Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Infliximab
Methylprednisolone Hemisuccinate
Prednisolone
Methylprednisolone
Methylprednisolone acetate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
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

ClinicalTrials.gov processed this record on September 16, 2014