drugset / Trial / NCT05805930
Therapeutic Approach in Colchicine-resistant Recurrent pEricarditis in Children
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to demonstrate that anakinra provides more rapid disease control than steroids in the first month of treatment in the event of recurrent pericarditis and is more effective in preventing further exacerbations in patients aged between eight months and eighteen years of age with idiopathic or post-procedural pericarditis, unresponsive to first-line treatment with NSAIDs and colchicine at the appropriate dosage, or in case of colchicine intolerance. The efficacy of the two treatments will be evaluated by the capacity and timing of the two therapies to determine a complete control (clinical, laboratory and instrumental) of the disease and the absence of recurrences.
Timeline
- Start
- 2023-06-01
- Primary completion
- 2025-06-01
- Completion
- 2026-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anakinra | Protein / enzyme biologic | 2 mg/kg | — |
| Comparator | Prednisone | Other / unclassified | 1 mg/kg | — |