Ignite Creation Date:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2026-04-21 @ 2:36 PM
Study NCT ID:
NCT02219828
Status:
COMPLETED
Last Update Posted:
2015-12-18
First Post:
2014-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AnakInRa for Treatment of Recurrent Idiopathic Pericarditis (AIRTRIP)
Sponsor:
Massimo Imazio
Organization:
Study Overview
Official Title:
AnakInRa for Treatment of Recurrent Idiopathic Pericarditis
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AIR TRIP
Brief 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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2013-001849-13 | EUDRACT_NUMBER | None | View |