The Efficacy of Intravenous Pulse in Attaining Remission in Refractory Juvenile Idiopathic Arthritis
- Conditions
- Refractory Juvenile Idiopathic Arthritis (Despite 2 DMARDs Still Active)
- Interventions
- Drug: Solumedrol
- Registration Number
- NCT06463379
- Lead Sponsor
- Sohag University
- Brief Summary
Interventional phase 3 study aiming to unravel the value of pulse steroids in achieving remission or low disease activity in refractory active JIA
- Detailed Description
First group will receive 2 consecutive days intravenous pulse of 125 mg methylprednisolone.
Second group will not receive additional drugs. Assessment was done at baseline and every month for 3 months for both groups using Juvenile Arthritis Disease Activity Score (JADAS) and the American College of Rheumatology Pediatric 30, 50, and 70 response criteria (ACR Pedi. 30, 50, 70).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 215
- Patients still active despite administration o 2 DMARDs
- Other connective tissue diseases
- Endocrine disorders such as Thyroid disorders.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description without pulse Solumedrol 107 patients will not receive any additional medications. pulse steroid Solumedrol 108 patients will receive 125 mg solumedrol intravenous pulse for 2 consecutive days plus their concomitant medication.
- Primary Outcome Measures
Name Time Method remission or low disease activity 3 months patients will be assessed at baseline and every month for 3 months using Juvenile Arthritis Disease Activity Score (JADAS) for disease activity American College of Rheumatology Pediatric 30, 50, and 70 (ACR Pedi. 30, 50, 70) for disease activity
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Al-Azhar University
🇪🇬Cairo, Egypt