Study on Anakinra and Colchicine for Painful Attacks in Familial Mediterranean Fever Patients Resistant to Colchicine Therapy

3 1 1 1

What is this study about?

This clinical trial is focused on studying Familial Mediterranean Fever (FMF), a genetic condition that causes recurrent episodes of fever and inflammation, often leading to pain in the abdomen, chest, or joints. The study is investigating the effectiveness of a treatment using Anakinra, a medication given as an injection, for patients who experience painful attacks despite being on long-term treatment with Colchicine, a standard medication for FMF. Some patients may not want to take daily injections, so this study looks at using Anakinra only when needed during an attack.

The purpose of the study is to evaluate how well Anakinra works in reducing the symptoms of FMF attacks in patients who are resistant to Colchicine and prefer not to have continuous daily therapy. Participants will continue their regular Colchicine treatment and will have the option to use Anakinra during an attack or when they anticipate an attack due to known triggers. The study will compare this approach to the standard care, which involves taking pain relief medications as needed along with daily Colchicine.

Throughout the study, participants will be monitored over a period of six months to assess the number of painful days they experience each month. The study will also look at the overall quality of life and any side effects, such as skin reactions at the injection site. The goal is to determine if on-demand Anakinra can provide better management of FMF symptoms compared to the current standard treatment.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age and diagnosis of Familial Mediterranean Fever (FMF).

Participants must have a history of FMF attacks despite maximum daily doses of colchicine and must refuse daily anakinra injections.

2 initial treatment phase

Participants continue their regular daily dose of colchicine (1 mg tablet, taken orally).

During an FMF attack, participants may receive anakinra (100 mg solution for injection) administered subcutaneously from the start of symptoms until 24 hours after symptoms resolve, for a maximum of 7 days.

3 monitoring and assessment

The primary goal is to evaluate the number of painful days per month over a 6-month period.

Secondary assessments include the total days of FMF attack treatment, severity of attacks, and quality of life scores.

4 safety evaluation

Safety is monitored by recording any local skin reactions at injection sites and other adverse events.

Participants are observed for any erythema or swelling at the injection sites.

5 completion of the trial

The trial is expected to conclude by June 15, 2026.

Final assessments will include a review of the efficacy and safety data collected throughout the study.

Who Can Join the Study?

  • Must be older than 6 years, with no upper age limit.
  • Must have a confirmed diagnosis of Familial Mediterranean Fever (FMF) based on specific international criteria and have two clear genetic mutations related to FMF.
  • Must show resistance to Colchicine, meaning they continue to have FMF attacks despite taking the maximum daily dose of Colchicine. This is defined as having one or more attacks per month over a 3-month period.
  • FMF attacks are identified by symptoms such as joint pain (arthritis), chest pain, stomach pain, muscle pain (myalgia), or skin rashes that look like erysipelas, lasting 1 to 4 days.
  • Must refuse daily injections of a medication called Anakinra.
  • Must have full health insurance coverage.
  • Must not have signs of inflammation in the body between FMF attacks.
  • Must provide written consent to participate, either by themselves or through their legal representatives.

Who Cannot Join the Study?

  • Patients who are not diagnosed with Familial Mediterranean Fever (FMF). FMF is a genetic condition that causes repeated episodes of fever and inflammation.
  • Patients who are not resistant to Colchicine. Colchicine is a medication used to treat FMF, and being resistant means it does not work effectively for the patient.
  • Patients who are not willing to refuse continuous daily therapy. This means patients must be open to trying a different treatment approach instead of taking medication every day.
  • Patients who are not between the ages of 4 and 18 years old. The study is only for children and teenagers within this age range.
  • Patients who are not able to understand or follow the study procedures. This means they must be able to follow instructions and understand what the study involves.
  • Patients who are not able to provide consent or do not have a legal guardian to provide consent on their behalf. Consent is necessary to participate in the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France

Other Sites

Site Name City Country Status
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Hopital Tenon Paris France
Robert Debre University Hospital Paris France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Aaxzfmumsm Pgqnmwrp Hyxmjean Da Mtccuiool Marseille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
15.01.2024

Trial locations

Investigated drugs:

Colchicine is a medication used daily in this trial to help manage symptoms of familial Mediterranean fever (FMF). It is typically used to reduce inflammation and prevent attacks in patients with FMF. In this study, it is given to patients who are resistant to its effects but continue to take it as part of their treatment plan.

Anakinra is used on-demand in this trial for patients experiencing painful FMF attacks. It is an injectable medication that helps reduce inflammation and is administered from the early signs of an attack until symptoms improve, for a maximum of seven days. It can also be used to prevent an attack if a known trigger is present.

Antalgics are pain-relieving medications used on-demand in this trial to help manage pain during FMF attacks. They are part of the standard care treatment and are used alongside daily colchicine to provide relief from the discomfort associated with FMF attacks.

Familial Mediterranean Fever – Familial Mediterranean Fever (FMF) is a genetic disorder characterized by recurrent episodes of fever and inflammation in the abdomen, chest, or joints. These episodes, known as attacks, can last from a few hours to several days and often occur without warning. The inflammation is caused by a defect in the MEFV gene, which leads to an overactive inflammatory response. Symptoms typically begin in childhood or adolescence and may include fever, abdominal pain, chest pain, and swollen joints. Over time, repeated inflammation can lead to complications such as amyloidosis, where protein builds up in organs. FMF is more common in people of Mediterranean descent, including those of Turkish, Arab, Armenian, and Jewish ancestry.

Trial ID:
2023-506721-11-00
NCT ID:
NCT06336733
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Venetoclax plus drug combination versus drug combination alone in children with relapsed acute myeloid leukemia

    Recruiting

    3 1 1 1
    Austria Belgium Czechia Denmark Finland France +8
  • A study to evaluate the efficacy and safety of depemokimab and salbutamol sulfate in patients with chronic obstructive pulmonary disease and type 2 inflammation.

    Recruiting

    3 1 1
    Belgium Bulgaria Denmark France Germany Greece +6