Phase 3 clinical study of MRA in patients with systemic juvenile idiopathic arthritis (sJIA)
Phase 3
- Conditions
- sJIA
- Registration Number
- JPRN-jRCT2080220017
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Inclusion criteria
1. Patients with sJIA diagnosed according to the revised 1997 ILAR (the International league of associations for Rheumatology) criteria
2. 2 and over Age and below 20
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method [Open label phase] Efficacy: JIA core set improvement. [Double blind phase] Efficacy: The main efficacy endpoint in the double blind withdrawal phase is the portion of patients maintaining JIA core set improvement. Safety: Frequency and severity of adverse events and adverse drug reactions
- Secondary Outcome Measures
Name Time Method