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

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What is this study about?

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.

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 initial assessment

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

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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Ospedale Vito Fazzi Lecce	Lecce	Italy
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
ASST Fatebenefratelli Sacco	Milan	Italy
Azienda Ospedaliera Universitaria Meyer IRCCS	Florence	Italy
ARNAS Civico Di Cristina Benfratelli	Palermo	Italy
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo	Trieste	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
IRCCS Istituto Giannina Gaslini	Genoa	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Adkfbmj Olbwywzqalb Uyhewnrnuizre Srlqdq	Siena	Italy
Apwtnli Oewnyejsfwk Usymzwugustgx Cslzxiukquxm Dngue Swvjrc E Dztkt Slixife Dd Tndmyj	Turin	Italy
Alpzptu Ugtsz Svuqqmjgf Lruheb Dd Bijgwna	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.07.2023

Trial locations

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.

Investigated diseases:

Pericarditis

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 ID:

2023-504756-96-00

Protocol code:

The CREATE Trial

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?