Status:
COMPLETED
Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)
Lead Sponsor:
Chugai Pharmaceutical
Conditions:
Systemic Juvenile Idiopathic Arthritis
Eligibility:
All Genders
2-19 years
Phase:
PHASE3
Brief Summary
This is an open-label, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with pJIA.
Eligibility Criteria
Inclusion
- Inclusion criteria
- Patients who are diagnosed with rheumatoid factor (RF) positive or negative polyarthritic or oligoarthritic JIA according to the ILAR standards (1997)
- Patients aged at least 2 years old and less than 20.
- Patients aged less than 16 years old at time of onset
- Exclusion criteria
- Patients with Class IV Steinbrocker functional disorder at evaluation within 2 weeks before initiation of treatment with the investigational product
- Patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept, within 12 weeks before initiation of treatment with the investigational product
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00144664
Start Date
November 1 2004
End Date
October 1 2005
Last Update
July 30 2008
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