Therapeutic Approach in Colchicine-resistant Recurrent pEricarditis in Children (NCT05805930) | Clinical Trial Compass
UnknownPhase 3
Therapeutic Approach in Colchicine-resistant Recurrent pEricarditis in Children
48 participantsStarted 2023-06-01
Plain-language summary
The purpose of this study is to demonstrate that anakinra provides more rapid disease control than steroids in the first month of treatment in the event of recurrent pericarditis and is more effective in preventing further exacerbations in patients aged between eight months and eighteen years of age with idiopathic or post-procedural pericarditis, unresponsive to first-line treatment with NSAIDs and colchicine at the appropriate dosage, or in case of colchicine intolerance. The efficacy of the two treatments will be evaluated by the capacity and timing of the two therapies to determine a complete control (clinical, laboratory and instrumental) of the disease and the absence of recurrences.
Who can participate
Age range
8 Months – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and female patients.
. Parent or legal guardian written informed consent and child assent, if appropriate, are required before any assessment is performed.
. Diagnosis of relapse of pericarditis in a patient with previous diagnosis of acute pericarditis (idiopathic or secondary to invasive cardiac procedures).
. Inadequate response or intolerance to non-steroidal anti-inflammatory drugs or colchicine
Exclusion criteria
. Pericarditis secondary to a known infection (viral, bacterial, mycobacterial).
. Pericarditis in a patient with a previous diagnosis of any neoplasm and without complete recovery from at least one year.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with complete response to treatment
. Pericarditis in the context of a systemic disease.
. Patients fulfilling diagnostic criteria for an autoimmune systemic disease
. Patients with a previous diagnosis of a genetically confirmed autoinflammatory disease
. Any conditions or significant medical problems, which in the opinion of the investigator places the patient at unacceptable risk for immunomodulatory therapy.
. Main alteration in the blood count
. Presence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B or Hepatitis C infections.