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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.
Last refreshed on: 19 February 2015
Main ID:  NCT00236028
Date of registration: 07/10/2005
Prospective Registration: No
Primary sponsor: Centocor, Inc.
Public title: A Safety and Efficacy Study for Infliximab (Remicade) With Methotrexate in Patients With Early Rheumatoid Arthritis
Scientific title: A Randomized, Double-blind, Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate Compared With Methotrexate Alone for the Treatment of Patients With Early Rheumatoid Arthritis
Date of first enrolment: November 2004
Target sample size: 607
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Name:     Centocor, Inc. Clinical Trial
Affiliation:  Centocor, Inc.
Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of rheumatoid arthritis for at least 3 months and less than or equal to 3
years before screening

- Active disease at the time of screening and pre-infusion of the drug

Exclusion Criteria:

- Pregnant, nursing, or planning a pregnancy within 18 months of enrollment

- Incapacitated, largely or wholly bedridden, or confined to a wheelchair, or had
little or no ability for self care

- Rheumatic disease other than rheumatoid arthritis or any current systemic
inflammatory condition

Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Drug: Infliximab
Primary Outcome(s)
Improvement from baseline in clinical signs and symptoms, prevention of structural damage, and prevention of physical disability evaluated at week 54.
Secondary Outcome(s)
Safety assessments throughout the study.
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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