Therapeutic Approach in Colchicine-resistant Recurrent pEricarditis in Children (NCT05805930) | Clinical Trial Compass
Not Yet RecruitingPhase 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 range8 Months – 18 Years
SexALL
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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.
✕. 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
What they're measuring
1
Number of participants with complete response to treatment
✕. 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.