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 — KIN-ATTACK-FMF

FMF Clinical Trial

Official title:
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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

KIN-ATTACK-FMF will be the first randomized prospective study comparing the efficacy of on-demand anakinra versus standard of care treatment in patients with colchicine resistant symptoms of FMF who refuse continuous daily therapy. Familial Mediterranean fever (FMF) is the most common monogenic autoinflammatory disease (100,000 people worldwide and 7500 in France). It causes monthly recurrent febrile abdominal pain with a biological inflammatory syndrome. To prevent FMF attacks and development of inflammatory amyloidosis (IA) daily oral colchicine is the first line recommended treatment. 10 to 15% of patients are resistant to colchicine: persistence of 1attack/month over a period of 3 months (in spite of taking the maximum tolerated dose of colchicine daily). Subcutaneous anti-interleukin 1 biotherapies were recently allowed in France combined to daily oral colchicine for colchicine resistant FMF: anakinra (short-acting anti-IL1 drug, daily) or canakinumab (long acting monoclonal anti IL1 antibody, every 2 months). These treatments cost respectively 30 and 12,000 euros/injection. If abdominal attacks are controlled by colchicine, patients still suffer from lower limb pains, particularly erysipelas like erythema and exertional myalgias, which are very disabling and require use of analgesics or anti-inflammatory. However, in the referral center, 20% of colchicine resistant FMF patients don't receive chronic anti IL1 treatment, despite an indication. Main reasons are: 1-they do not want to inject themselves every day (for anakinra); 2-women of childbearing age are afraid about the impact of biotherapies on their fetus; 3-some do not want to ask for 100% coverage because of the biotherapy cost; 4- the authorization for anti IL1 in FMF is very recent and they want more certainty about its effectiveness. The hypothesis of the study is that on-demand use of Anakinra from onset of attack until 24 hours of remission (during 7 days maximum) associated with chronic daily colchicine as background treatment in case of attack could stop it, thus reducing its length and pain compared to standard of care treatment which includes only classical antalgics with colchicine in patients refusing chronic daily anti IL1 treatment. In the experimental arm, patients receive 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. In the control arm, patients receive analgesics associated with daily colchicine. 50 participants should be included in the study during a period of 24 months with a 6 months participation period (treatment + follow up) It's a Multicenter national study including 11 centers. ;

Study Design

Related Conditions & MeSH terms

Brucellosis
Familial Mediterranean Fever
FMF
Hereditary Autoinflammatory Diseases

Clinical Trial Details

NCT number	NCT06336733
Study type	Interventional
Source	Assistance Publique - Hôpitaux de Paris
Contact	Léa SAVEY
Phone	0033 1 56 01 67 91
Email	lea.savey@aphp.fr
Status	Not yet recruiting
Phase	Phase 3
Start date	March 2024
Completion date	September 15, 2026

View Details

See also
Status	Clinical Trial	Phase
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Recruiting	`NCT03210610` - Colchicine Levels in the Serum of FMF (Familial Mediterranean Fever) Patients
Not yet recruiting	`NCT05292768` - Are Mast Cells Involved in Autoinflammatory Diseases
Enrolling by invitation	`NCT04402255` - Pilates Based Exercises in Patients With Behçet and Familial Mediterranean Fever.	N/A
Completed	`NCT02466217` - Phenomics in Autoimmune and Inflammatory Diseases
Recruiting	`NCT05980780` - The Effect of Video Game on Children With Familial Mediterranean Fever	N/A
Completed	`NCT05398536` - Kinesiophobia in Familial Mediterranean Fever
Not yet recruiting	`NCT06047938` - FMF and Atheroscelerosis
Recruiting	`NCT05092776` - Efficacy and Safety of RPH-104 for Resolution and Prevention of Recurring Attacks in Adult Subjects With Familial Mediterranean Fever With Resistance to or Intolerance of Colchicine	Phase 2
Enrolling by invitation	`NCT04403438` - Familial Mediterranean Fever and Behçet: Analysis Before and After Covid19 Pandemic

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.