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Study Comparing Anakinra and Prednisone for Children with Colchicine-Resistant Recurrent Pericarditis

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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 a condition called recurrent pericarditis, which is a repeated inflammation of the thin sac-like covering of the heart. This condition can occur without a known cause or as a result of heart procedures and does not respond well to common treatments like colchicine and non-steroidal anti-inflammatory drugs (NSAIDs). The trial is specifically for children who have experienced a relapse of pericarditis and have not had success with these initial treatments.

The study will compare two treatments: Anakinra, which is given as an injection under the skin, and Prednisone, a type of steroid taken in tablet form. Anakinra is a medication that helps reduce inflammation by blocking certain proteins in the body, while Prednisone is a corticosteroid that also helps to reduce inflammation and suppress the immune system. The main goal of the study is to determine if Anakinra is more effective than steroids in controlling the disease and preventing further flare-ups in children who have not responded to first-line treatments.

Participants in the study will receive either Anakinra or Prednisone for a period of up to 24 weeks. The study will monitor the response to treatment, including the complete response of disease flare at day 7 and the lack of relapse at month 3. Other aspects such as the time it takes to control the flare, the number of flare-ups during follow-up, and the overall quality of life will also be observed. Safety will be closely monitored throughout the study to record any side effects. The study aims to provide valuable information on the effectiveness and safety of these treatments for children with recurrent pericarditis.

The research process

The trial runs in 6 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, the patient must have a diagnosis of recurrent pericarditis that is not responsive to colchicine and NSAIDs. The patient should be between 8 months and less than 18 years old.

    Written informed consent from a parent or legal guardian, and child assent if appropriate, are required before any assessments are performed.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm the diagnosis of pericarditis relapse and to ensure eligibility for the trial.

  3. Step 3

    Treatment allocation

    The patient will be randomly assigned to receive either anakinra or steroids as part of the treatment plan.

    Anakinra is administered as a subcutaneous injection using a pre-filled syringe containing 100 mg/0.67 ml solution.

  4. Step 4

    Treatment administration

    If assigned to the anakinra group, the patient will receive the medication through subcutaneous injection. The dosage and frequency will be determined by the study protocol.

    If assigned to the steroid group, the patient will receive prednisone orally. The dosage and frequency will be determined by the study protocol.

  5. Step 5

    Monitoring and follow-up

    The patient's response to treatment will be monitored, with a primary focus on achieving a complete response to the disease flare by day 7 and preventing relapse by month 3.

    Secondary outcomes include the time to achieve complete control of the flare, the time to flare after treatment tapering, and the number of flares during follow-up.

  6. Step 6

    Observation period

    The patient will be observed for a period of 6 months to monitor the behavior of acute phase reactants, quality of life, and safety, including any side effects.

    The number of days of hospitalization and a transcriptomic study will also be part of the observation.

Who can join the trial?

4 criteria

  • Patients must be **male or female** and aged from **8 months to less than 18 years**.
  • A **written informed consent** from a parent or legal guardian is required. If suitable, the child must also agree to participate.
  • The patient must have a **relapse of pericarditis**, which means the condition has returned after being diagnosed with **acute pericarditis**. This can be either **idiopathic** (unknown cause) or due to **invasive cardiac procedures** (medical procedures involving the heart).
  • The patient must have an **inadequate response** or **intolerance** to **non-steroidal anti-inflammatory drugs (NSAIDs)** or **colchicine**. This means the medications did not work well or caused side effects that the patient could not tolerate.

Who cannot join the trial?

5 criteria

  • Patients who have not experienced a return of symptoms after the first treatment with colchicine and NSAIDs (non-steroidal anti-inflammatory drugs).
  • Patients who have not been diagnosed with **recurrent pericarditis**. This is a condition where the sac around the heart becomes inflamed repeatedly.
  • Patients who are responding well to colchicine and NSAIDs after the first return of symptoms.
  • Patients who are not intolerant to colchicine. Intolerance means they cannot take the medication due to side effects or other issues.
  • Patients who are not within the age range of 8 months to less than 18 years.
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Investigated drugs

  • Anakinra

    is a medication used in this trial to treat children with recurrent pericarditis who do not respond to other treatments. It works by blocking a specific protein in the body that causes inflammation, helping to reduce symptoms and prevent future episodes of the disease.

  • Steroids

    are another treatment option in this trial. They are used to reduce inflammation and suppress the immune system, which can help control the symptoms of recurrent pericarditis in children. The trial aims to compare the effectiveness of steroids with anakinra in managing the condition.

What is already known about the treatment

Anakinra – Anakinra is administered through subcutaneous injection and is currently being studied for its effectiveness in treating recurrent pericarditis in children who do not respond to standard treatments like colchicine and NSAIDs. It is an approved medication in medical literature for other inflammatory conditions and is being evaluated for this specific use. The main therapeutic indication is to control disease symptoms and prevent further flares in pediatric patients. Anakinra works by blocking the activity of interleukin-1, a protein involved in inflammatory responses, thereby reducing inflammation. It is classified as an interleukin-1 receptor antagonist.

Investigated diseases

Recurrent Pericarditis – Recurrent pericarditis is a condition characterized by repeated episodes of inflammation of the pericardium, the thin sac-like membrane surrounding the heart. It can be idiopathic, meaning the cause is unknown, or secondary to invasive cardiac procedures. The disease often presents with chest pain, fever, and a pericardial friction rub, which is a specific sound heard with a stethoscope. In some cases, it does not respond to standard treatments like colchicine and nonsteroidal anti-inflammatory drugs (NSAIDs) after the first relapse. The inflammation can lead to fluid accumulation around the heart, causing discomfort and other symptoms. The condition can be challenging to manage, especially in patients who do not respond to initial treatments.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2023-504756-96-00Protocol codeThe CREATE TrialEstimated enrolment48 patientsSponsorIRCCS Istituto Giannina Gaslini

sourced from the EU Clinical Trials Register and site verification

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