Status:
COMPLETED
Long-term Treatment Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)
Lead Sponsor:
Chugai Pharmaceutical
Conditions:
Polyarticular Juvenile Idiopathic Arthritis
Eligibility:
All Genders
2-19 years
Phase:
PHASE3
Brief Summary
This is an open-label, extension, Phase III study to evaluate the long-term safety, efficacy and PK of MRA in patients with pJIA who participated in Study MRA318JP.
Eligibility Criteria
Inclusion
- Inclusion criteria
- Of the patients who received three infusions with MRA in the previous study and for whom a last observation was conducted
- the patients who did not have problems with safety in the previous study"
- Exclusion criteria
- Patients who were not enrolled by 3 months after completion of the previous study
- Patients who received any of the following since completion of the previous study until initiation of treatment in the present study
- DMARDs or immunosuppressants
- Intravenous and intramuscular injection of corticosteroids
- Plasma exchange therapy
- Other drugs and therapies that may affect evaluation of drug efficacy
Exclusion
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00144625
Start Date
February 1 2005
End Date
June 1 2009
Last Update
December 23 2009
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