Therapeutic Approach in Colchicine-resistant Recurrent pEricarditis in Children

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

June 1, 2023

Primary Completion Date

June 1, 2025

Study Completion Date

May 31, 2026

Conditions
Pericarditis
Interventions
DRUG

Anakinra

: Patients will continue daily treatment with anakinra up to week 12. Treatment will be then progressively tapered through the reduction of an administration of the drug per week. Reductions will be performed every 2 weeks up to discontinuation. Therefore, if a relapse does not occur, the treatment will be withdrawn at week 24.

DRUG

Prednisone

Steroids will be progressively tapered with a reduction of 0,1-0,15 mg/kg/day of prednisone (or 5 mg in patients in treatment with the maximum dosage of 50 mg/day) from the ongoing treatment every week up to discontinuation. If a relapse does not occur, the treatment will be withdrawn in a period of time of 10 weeks.

All Listed Sponsors
lead

Istituto Giannina Gaslini

OTHER

NCT05805930 - Therapeutic Approach in Colchicine-resistant Recurrent pEricarditis in Children | Biotech Hunter | Biotech Hunter