NCT02219828

AnakInRa for Treatment of Recurrent Idiopathic Pericarditis (AIRTRIP)

AnakInRa for Treatment of Recurrent Idiopathic Pericarditis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Massimo Imazio · Academic / Other
• Sex: All
• Age: 5 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Recent findings suggest that recurrent pericarditis (RP) may be a previously unrecognized autoinflammatory disease. The pivotal pathogenic role of interleukin (IL)-1 in RP has been shown by the achievement of complete responses after treatment with the recombinant IL-1-receptor antagonist, anakinra. Anakinra is the recombinant form of IL-1Ra. The proposed study is designed to demonstarate the efficacy of anakinra in RP.

Detailed description

This is a 8-month, multicenter (3 Italian centers), randomized, double-blind, placebo-controlled, multicenter, medication-withdrawal study to evaluate the efficacy, tolerability, and safety of anakinra in adults and children with idiopathic recurrent pericarditis (RP).

Conditions

• Idiopathic Recurrent Pericarditis

Interventions

Type	Name	Description
DRUG	Anakinra	2mg/Kg daily sc up to 100mgday as maximum dose
DRUG	Placebo	Placebo

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-07-01
• Completion: 2015-10-01
• First posted: 2014-08-19
• Last updated: 2015-12-18

Locations

3 sites across 1 country: Italy