Therapeutic approach in Colchicine-resistant Recurrent pEricarditis in children: an open-label randomized trial comparing Anakinra vs sTEroids

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504756-96-00

Acronym

The CREATE Trial

Enrollment

Registered

2023-10-23

Start date

2024-03-22

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent pericarditis, idiopathic or secondary to invasive cardiac procedures, not responsive to colchicine and NSAIDs after the first relapse.

Brief summary

Complete response of disease flare at day 7, Lack of relapse at month 3

Detailed description

Time to achieve a complete control of the flare, Time to flare after treatment tapering, Number of flares at follow up, Behavior of acute phase reactants during 6 months of observation, Quality of life, Safety (registration of side effects occurred during the whole period of the study), Number of day of hospitalization, Transcriptomic study

Interventions

DRUGPREDNISONE

DRUGKineret 100 mg/0.67 ml solution for injection in pre-filled syringe.

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Complete response of disease flare at day 7, Lack of relapse at month 3	—

Secondary

Measure	Time frame
Time to achieve a complete control of the flare, Time to flare after treatment tapering, Number of flares at follow up, Behavior of acute phase reactants during 6 months of observation, Quality of life, Safety (registration of side effects occurred during the whole period of the study), Number of day of hospitalization, Transcriptomic study	—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026