drugset / Trial / NCT05805930

Therapeutic Approach in Colchicine-resistant Recurrent pEricarditis in Children

NCT05805930

Phase 3 Unknown 48 enrolled Gaslini Institute
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

EvaluationDrugModalityDoseRoute
Subject Anakinra Protein / enzyme biologic 2 mg/kg
Comparator Prednisone Other / unclassified 1 mg/kg

Indications