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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT00808210
Date of registration: 11/12/2008
Prospective Registration: Yes
Primary sponsor: Genentech, Inc.
Public title: 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
Scientific 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
Date of first enrolment: March 5, 2009
Target sample size: 28
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT00808210
Study type:  Interventional
Study design:  Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Clinical Trials
Address: 
Telephone:
Email:
Affiliation:  Genentech, Inc.
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Infliximab
Drug: Methotrexate
Drug: Methylprednisolone
Drug: Ocrelizumab
Drug: Placebo
Primary Outcome(s)
Change From Baseline in DAS28(ESR) at Week 20 [Time Frame: Week 20]
Secondary Outcome(s)
Change in Fatigue Visual Analog Scale Score (VAS) [Time Frame: Baseline up to 30 months]
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score [Time Frame: Baseline up to 30 months]
European League Against Rheumatism (EULAR) Response Rates [Time Frame: Baseline up to 30 months]
Percentage of Participants With Adverse Events (AEs) [Time Frame: Baseline up to 30 months]
Percentage of Participants With Clinical Response of 20% According to ACR Criteria [Time Frame: Baseline up to 30 months]
Percentage of Participants With Clinical Response of 50% According to ACR Criteria [Time Frame: Baseline up to 30 months]
Percentage of Participants With Clinical Response of 70% According to ACR Criteria [Time Frame: Baseline up to 30 months]
Secondary ID(s)
ACT4562g
GA00931
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 06/11/2020
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00808210
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