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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:  NCT00269867
Date of registration: 22/12/2005
Prospective Registration: No
Primary sponsor: Centocor, Inc.
Public title: Infliximab Plus Methotrexate for the Treatment of Rheumatoid Arthritis
Scientific title: A Placebo-Controlled, Double-Blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment
Date of first enrolment: March 1997
Target sample size: 428
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Name:     Centocor, Inc. Clinical Trial
Affiliation:  Centocor, Inc.
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with active Rheumatoid Arthritis despite treatment with methotrexate

- Diagnosed with Rheumatoid Arthritis at least 6 months prior to screening

- Having active disease at the time of screening and pre-infusion as defined by having
at least 6 or more swollen joints and 6 or more tender joints

- Using methotrexate for at least 3 months prior to study enrollment

Exclusion Criteria:

- Patients having any systemic inflammatory condition

- Having Lyme disease or a rheumatic disease other than Rheumatoid Arthritis

- Who have used Disease-Modifying Antirheumatic Drugs (DMARDs) other than methotrexate
within 4 weeks prior to screening

- Who have used corticosteroids within 4 weeks prior to screening

- Having received previous administration of infliximab

Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Drug: Infliximab 10 mg/kg
Drug: Infliximab 3 mg/kg
Drug: Placebo
Primary Outcome(s)
Change from baseline in ACR20 response at week 30; Change in modified van der Heijde-Sharp Score [Time Frame: Baseline and Week 30]
Secondary Outcome(s)
safety [Time Frame: up to Week 54]
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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