Therapeutic Approach in Colchicine-resistant Recurrent pEricarditis in Children: an Open-label Randomized Trial Comparing Anakinra vs sTEroids

CREATE

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.

2023-06-01

2025-06-01

2026-05-31

Not yet recruiting

Early phase I

48

Inclusion Criteria: 1. Male and female patients. 2. Parent or legal guardian written informed consent and child assent, if appropriate, are required before any assessment is performed. 3. Diagnosis of relapse of pericarditis in a patient with previous diagnosis of acute pericarditis (idiopathic or secondary to invasive cardiac procedures). 4. Inadequate response or intolerance to non-steroidal anti-inflammatory drugs or colchicine Exclusion Criteria: 1. Pericarditis secondary to a known infection (viral, bacterial, mycobacterial). 2. Pericarditis in a patient with a previous diagnosis of any neoplasm and without complete recovery from at least one year. 3. Pericarditis in the context of a systemic disease. 1. Patients fulfilling diagnostic criteria for an autoimmune systemic disease 2. Patients with a previous diagnosis of a genetically confirmed autoinflammatory disease 4. Any conditions or significant medical problems, which in the opinion of the investigator places the patient at unacceptable risk for immunomodulatory therapy. 5. Main alteration in the blood count 6. Presence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B or Hepatitis C infections. 7. Evidence of active or latent tuberculosis (TB) determined by positive QuantiFERON (QFT-TB G In-Tube) test or positive Purified Protein Derivative (PPD) test (≥5 mm induration) within 2 months prior to randomization. 8. Administration of any investigational drug or implantation of investigational device, or participation in another trial, within 30 days before screening. 9. Use of steroids at the dosage of 1 mg/kg/day of prednisone or equivalent for at least 5 days in the 30 days before randomization. 10. Live vaccinations within 1 months prior to the start of the trial and during the trial. 11. Pregnancy, confirmed by a positive hCG laboratory test. 12. Female adolescents (≤18 years of age) of childbearing potential who do not agree to abstinence or, if sexually active, do not agree to the use of contraception. -

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 48, 'type': 'ESTIMATED'}}

2023-04-10