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
Condition(s) studied
Investigational drug(s) / intervention(s)
ANAKINRA: On demand Anakinra 100 mg/j from the prodromal phase of the attack until 24 hours of remission (during 7 days maximum) + colchicine + on demand analgesics
Study 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.
Eligibility
Primary outcome measure(s)
- Mean number of FMF-attacks per month at 6 months of treatment. — At Months 0 (baseline), Month 1, Month 3 and Month 6
* FMF attacks is defined by a painful (consensual definition) manifestation during 12 to 72 hours, in either : * abdomen (with features consistent with a diagnosis of peritonitis), * chest (with features consistent with a diagnosis of pleuritis), * joints (with features consistent with a diagnosis of lower extremity large joint monoarthritis), * skin (with features consistent with a diagnosis of erysipeloid rash) * The painful manifestation can be (or not) accompanied by fever of ≥ 38°C Patients will be asked to note the number of days of pain of each inflammatory attack on a diary.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Service de Médecine interne Hopital Tenon | Paris | France | Recruiting |
On this site
📄 Kineret (anakinra) drug profile →More Assistance Publique - Hôpitaux de Paris trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06336733 on ClinicalTrials.gov ↗ ← All trials in France