Trial of oral drug Tofacitinib in juvenile spondyloarthritis
Phase 4
- Conditions
- Health Condition 1: M081- Juvenile ankylosing spondylitis
- Registration Number
- CTRI/2022/12/048330
- Lead Sponsor
- Sanjay Gandhi Postgraduate Institute off Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Children with JIA-ERA with total disease duration <5 years and who are above 5 years and below 18 years of age with BASDAI >4 and elevated ESR >30 or CRP >6 mg/L while on NSAIDS and Methotrexate for at least 3 months.
Exclusion Criteria
Those with active TB/infections, transaminitis ( >3 times ULN), any organ damage, cancer, <5 years of age, inactive disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients achieving ASAS 20 response at week 16 <br/ ><br>Proportions of patients achieving clinically important improvement in ASDAS-CRP (Decrease of 1.1 from baseline) at week 16.Timepoint: 0, 8, 16 weeks
- Secondary Outcome Measures
Name Time Method Delta BASFI, BASDAI 50 response, jsPADA, BASMI, BASFI, CRP, cytokine levelsTimepoint: 16 weeks