drugset / Trial / NCT06336733

Randomized Controlled Trial in Patients on Long-term Colchicine With Colchicine-resistant Familial Mediterranean Fever (FMF) to Evaluate the Efficacy of On-demand Anakinra Treatment for Painful Attacks in Patients Who Refuse Continuous Daily Therapy

NCT06336733

Phase 3 Recruiting 50 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupOpen-labelTreatment

Summary

To evaluate the efficacy on clinical symptoms in case of FMF attack among FMF patients resistant to Colchicine of * on demand anakinra treatment (100 mg/d from the prodromal phase of the attack until 24 hours of remission (during 7 days maximum) associated with daily colchicine. * compared to analgesic associated with daily colchicine in patients refusing continuous anti-IL-1 treatment.

Timeline

Start
2024-06-04
Primary completion
2026-12-04
Completion
2026-12-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Anakinra Protein / enzyme biologic 100 mg Subcutaneous