Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06336733
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-03-15
Brief 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
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
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
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KIN-ATTACK-FMF
Brief 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 mgd 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
on demand anakinra treatment 100 mgd 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
Detailed 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 100000 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 1attackmonth 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 12000 eurosinjection
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 dont 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 mgd 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
Its a Multicenter national study including 11 centers
Familial Mediterranean fever FMF is the most common monogenic autoinflammatory disease 100000 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 1attackmonth 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 12000 eurosinjection
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 dont 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 mgd 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
Its a Multicenter national study including 11 centers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None