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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

8 criteria

  • 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 trial?

6 criteria

  • 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.
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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.

What is already known about the treatment

Anakinra – Anakinra is administered through subcutaneous injection and is currently being studied for its effectiveness in treating Familial Mediterranean Fever (FMF) attacks in patients who are resistant to colchicine and prefer not to take continuous daily therapy. It is primarily used to manage symptoms during FMF attacks by reducing inflammation. Anakinra works by blocking the activity of interleukin-1, a protein in the body that contributes to inflammation. It is classified as an interleukin-1 receptor antagonist.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506721-11-00Estimated enrolment50 patientsSponsorAssistance Publique Hopitaux De Paris

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