Status:
COMPLETED
Long-term Treatment 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
An open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with sJIA who were participated in Studies MRA011JP or MRA316JP
Eligibility Criteria
Inclusion
- Inclusion criteria (MRA011JP patients)
- Of the patients who received the three infusions of MRA at the same dose in the main evaluation period in the previous study and are currently in the continued treatment period
- the patients in whom it is confirmed that the drug is effective and there are no problems with safety (MRA316JP patients)
- Patients who proceed to the blind period and in whom the last observations are done after study completion or withdrawal
- Patients who receive the three infusions in the open-label period and do not meet the criteria for transition to the blind period
- Exclusion criteria
- Patients who were not enrolled by 3 months after completion of the previous study
- Patients who have been treated with infliximab or etanercept from completion of the previous study until the start of treatment in this study
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00144612
Start Date
July 1 2004
End Date
June 1 2009
Last Update
December 23 2009
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