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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 October 2017
Main ID:  NCT00207714
Date of registration: 13/09/2005
Prospective Registration: No
Primary sponsor: Centocor, Inc.
Public title: An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis
Scientific title: A Randomized, Double-blind, Dose-ranging Trial of CNTO 148 Subcutaneous Injection Compared With Placebo in Subjects With Active Rheumatoid Arthritis Despite Treatment With Methotrexate
Date of first enrolment: November 2003
Target sample size: 172
Recruitment status: Completed
Study type:  Interventional
Study design:   
Phase:  Phase 2
Countries of recruitment
Name:     Centocor, Inc. Clinical Trial
Affiliation:  Centocor, Inc.
Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of RA according to the American College of Rheumatology criteria for at
least 3 months prior to screening

- Have active Rheumatoid Arthritis at the time of screening and at baseline, as defined
by 6 or more swollen joints and 6 or more tender joints and additional laboratory

Exclusion Criteria:

- Have other inflammatory diseases, including but not limited to ankylosing spondylitis,
systemic lupus erythematosus, Lyme disease

- Received disease-modifying antirheumatic drugs ([DMARDs] eg, D penicillamine,
hydroxychloroquine, chloroquine, oral or parenteral gold, interleukin [IL]-1 receptor
antagonist [anakinra], azathioprine, sulphasalazine, agents other than MTX) within 4
weeks prior to the first study dose

Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Drug: Golimumab
Drug: Infliximab
Drug: MTX
Drug: Placebo
Primary Outcome(s)
Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16 [Time Frame: Week 16]
Secondary Outcome(s)
Summary of ACR-N, Index of Improvement at Week 16 [Time Frame: Week 16]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Centocor BV
Ethics review
Results available: Yes
Date Posted: 07/08/2012
Date Completed:
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