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A clinical trial to study the benefits and side effects of addition of Pulse steroids (Dexamethasone) to standard treatment in patients with juvenile idiopathic arthritis.

Efficacy of Pulse Dexamethasone in addition to standard therapy versus standard therapy alone in children with Juvenile Idiopathic Arthritis: A double blind randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/08/015151
Enrollment
60
Registered
2018-08-01
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Non Systemic-Onset Juvenile Idiopathic Arthritis Health Condition 2: M080- Unspecified juvenile rheumatoid arthritis

Interventions

Intervention1: Intravenous Dexamethasone: Intravenous Dexamethasone 3mg/kg/day (maximum: 100 mg) in 100ml of 5% dextrose over 3 hours, for 3 days 6 weekly for the total of 3 pulses in addition to stan

Sponsors

Department of Pediatrics
Lead Sponsor

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

MeasureTime frame
Proportion of Children achieving American College Of Rheumatology Pediatrics 70 (ACR 70) response.Timepoint: 16 weeks after initiation of therapy

Secondary

MeasureTime 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

Public ContactDr Umang Bhardwaj

Division of Pediatric Rheumatology Department of Pediatrics AlIMS, New Delhi

drnarendrabagri@yahoo.co.in9013545665

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 13, 2026