Clinical Research Directory
Browse clinical research sites, groups, and studies.
Therapeutic Approach in Colchicine-resistant Recurrent pEricarditis in Children
Sponsor: Istituto Giannina Gaslini
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.
Official title: Therapeutic Approach in Colchicine-resistant Recurrent pEricarditis in Children: an Open-label Randomized Trial Comparing Anakinra vs sTEroids
Key Details
Gender
All
Age Range
8 Months - 18 Years
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2023-06-01
Completion Date
2026-05-31
Last Updated
2023-04-10
Healthy Volunteers
No
Conditions
Interventions
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 Therefore, if a relapse does not occur, the treatment will be withdrawn at week 24.
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 If a relapse does not occur, the treatment will be withdrawn in a period of time of 10 weeks.