Using intravenous pulse steroids to treat refractory juvenile idiopathic arthritis
The Efficacy of Intravenous Pulse in Attaining Remission in Refractory Juvenile Idiopathic Arthritis
This study is testing if giving high doses of steroids through an IV can help kids with tough-to-treat juvenile idiopathic arthritis feel better when other medications haven't worked.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 215 (estimated) |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Sponsor | Sohag University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06463379 on ClinicalTrials.gov |
What this trial studies
This phase 3 interventional study evaluates the effectiveness of intravenous pulse steroids, specifically 125 mg of methylprednisolone administered over two consecutive days, in achieving remission or low disease activity in patients with refractory juvenile idiopathic arthritis (JIA) who remain active despite treatment with two disease-modifying antirheumatic drugs (DMARDs). Participants will be assessed at baseline and monthly for three months using the Juvenile Arthritis Disease Activity Score (JADAS) and the American College of Rheumatology Pediatric response criteria. The study aims to determine if this treatment can lead to significant improvements in disease activity.
Who should consider this trial
Good fit: Ideal candidates for this study are children and adolescents with refractory juvenile idiopathic arthritis who have not responded adequately to two DMARDs.
Not a fit: Patients with other connective tissue diseases or endocrine disorders such as thyroid disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with refractory juvenile idiopathic arthritis, potentially leading to remission or improved disease management.
How similar studies have performed: While the use of pulse steroids is a known treatment approach, this specific study's focus on refractory juvenile idiopathic arthritis represents a targeted investigation that may yield novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients still active despite administration o 2 DMARDs Exclusion Criteria: * Other connective tissue diseases * Endocrine disorders such as Thyroid disorders.
Where this trial is running
Cairo
- Al-Azhar University — Cairo, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.