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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:  NCT00036387
Date of registration: 09/05/2002
Prospective Registration: No
Primary sponsor: Centocor, Inc.
Public title: A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Rheumatoid Arthritis.
Scientific title: A Randomized, Double-blind Trial of the Safety of Anti-TNF Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid Arthritis on Standard Disease-modifying Anti-Rheumatic Drug Background Therapy.
Date of first enrolment: October 2001
Target sample size: 347
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
United States
Name:     Centocor, Inc. Clinical Trial
Affiliation:  Centocor, Inc.
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients must have a diagnosis of Rheumatoid Arthritis at least 3 months before

- If the patient is of childbearing potential, must have been using adequate birth
control measures

- Patients must be receiving MTX for =3 months before randomization and at a stable
dose(=25 mg/week) for =4 weeks before randomization

Exclusion Criteria:

- Patients must not be pregnant, nursing, or planning a pregnancy within 18 months of

- Patients must not have rheumatic disease other than Rheumatoid Arthritis or had any
systemic inflammatory condition

- Patients must not be confined to a wheelchair

- Patients must not be treated with any approved or investigational biologic agent
except for approved vaccines for immunizations

Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Arthritis, Rheumatoid
Drug: Infliximab
Primary Outcome(s)
The proportion of patients with serious infections occurring over the first 22 weeks of the trial
Secondary Outcome(s)
The proportion of patients with infections & atypical/opportunistic infections. The duration of most frequently reported infections. Proportion of patients achieving ACR 20 criteria at 22 weeks. Effect of 1.5 mg/kg dose increment in reducing disease
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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