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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anakinra | Protein / enzyme biologic | 100 mg | Subcutaneous |