Health Condition 1: null- Non Systemic-Onset Juvenile Idiopathic Arthritis Health Condition 2: M080- Unspecified juvenile rheumatoid arthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Children (age 1-16 years) diagnosed as non-systemic JIA as per ILAR criteria with any one of the following: 1. More than 5 active joint count 2. Involving Hip or Cervical joint
Exclusion criteria
Exclusion criteria: 1. Pretreatment with Methotrexate for >12 weeks in the preceding 12 months 2. Taken systemic steroids ( > 2mg/kg/day) for > 7 days in the preceding 6 months 3. Concurrent serious systemic infections requiring hospitalization and/ or intravenous antibiotics 4. Uncontrolled hypertension 5. Known cases of Diabetes mellitus 6. Evidence of Active Tuberculosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Children achieving American College Of Rheumatology Pediatrics 70 (ACR 70) response.Timepoint: 16 weeks after initiation of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Need for bridge steroids or Intra-articular corticosteroidsTimepoint: Anytime from initiation of therapy to 16 weeks after initiation of therapy;Number of children with adverse events in each groupsTimepoint: Anytime from initiation of therapy to 16 weeks after initiation of therapy;Proportion of Children achieving American College Of Rheumatology Pediatrics 30 and 50 (ACR 30 and ACR 50) response.Timepoint: 16 weeks after initiation of therapy | — |
Countries
India
Contacts
Division of Pediatric Rheumatology Department of Pediatrics AlIMS, New Delhi