Status:
COMPLETED
Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)
Lead Sponsor:
Chugai Pharmaceutical
Conditions:
Systemic Juvenile Idiopathic Arthritis
Eligibility:
All Genders
2-19 years
Phase:
PHASE3
Brief Summary
This is a double-blind, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with sJIA.
Eligibility Criteria
Inclusion
- Inclusion criteria
- Patients diagnosed as having systemic JIA based on the International League of Associations for Rheumatology criteria (1997)
- Patients between 2 and 19 years of age
- Patients who are under 16 years of age at onset
- Patients who have been treated with corticosteroids (continued treatment for 3 months or longer at a dose of ≥0.2 mg/kg as prednisolone equivalent) but who failed to respond adequately or in whom treatment could not be continued or the dose could not be increased due to adverse drug reactions
- Exclusion criteria
- Patients who have been treated with infliximab or etanercept within 12 weeks before treatment with the investigational product
- Patients who have received the following treatments within 4 weeks before treatment with the investigational product
- Surgical treatment (e.g., operation)
- Plasma exchange therapy"
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00144599
Start Date
May 1 2004
End Date
October 1 2005
Last Update
July 30 2008
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