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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: 19 February 2015
Main ID:  NCT00036374
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 Juvenile Rheumatoid Arthritis
Scientific title: A Randomized, Double-Blind Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate for the Treatment of Patients With Polyarticular Juvenile Rheumatoid Arthritis
Date of first enrolment: October 2001
Target sample size: 123
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00036374
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
Contacts
Name:     Centocor, Inc. Clinical Trial
Address: 
Telephone:
Email:
Affiliation:  Centocor, Inc.
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients must have a diagnosis of juvenile rheumatoid arthritis (JRA) with
polyarticular JRA for at least 6 months, systemic JRA with a polyarticular course and
no systemic symptoms (including fever, rash,hepatosplenomegaly, and serositis) for 1
year prior to study entry, or pauciarticular JRA with a polyarticular course for at
least 6 months prior to study entry. The patient should have had at least 6 months of
persistent synovitis before screening.

- The patient must have at least 5 joints with active arthritis (ie, presence of
swelling, or if no swelling is present, limitation of motion accompanied by pain,
tenderness, or both) at the time of enrollment, with at least 3 of these active
joints having limitation of motion accompanied by pain, tenderness, or both

- The patient must be at least 4 years of age, but less than 18 years (ie, after the
4th but before the 18th birthday), with onset of disease before age 16.

Exclusion Criteria:

- Patient must not be pregnant, nursing, or planning a pregnancy within 6 months after
the last study infusion

- Patient must not be incapacitated, largely or wholly bedridden, or confined to a
wheelchair, or have little or no ability for age-appropriate self care

- Patient must not have a rheumatic disease other than JRA or any current systemic
inflammatory condition (for example, Lyme disease,fibromyalgia, enthesitis-related
arthritis, psoriatic arthritis, systemic lupus erythematosus, infectious or reactive
arthritis, Reiter's syndrome, or parvovirus infection)



Age minimum: 4 Years
Age maximum: 18 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis, Juvenile
Intervention(s)
Drug: Infliximab
Primary Outcome(s)
The proportion of patients with improvements in the Juvenile Rheumatoid Arthritis core set criteria at Week 14 in the placebo group with that in the 3 mg/kg infliximab plus concomitant methotrexate therapy group.
Secondary Outcome(s)
To evaluate pharmacokinetics (rate of movement in the body and then the clearance)of infliximab over a maximum time period of 52 wks; to evaluate the safety profile of infliximab in patients with JRA
Secondary ID(s)
CR004774
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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