Therapeutic Approach in Colchicine-resistant Recurrent pEricarditis in Children (CREATE)
Pericarditis
About this trial
This is an interventional treatment trial for Pericarditis
Eligibility Criteria
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 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. 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. Administration of any investigational drug or implantation of investigational device, or participation in another trial, within 30 days before screening. 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. Live vaccinations within 1 months prior to the start of the trial and during the trial. Pregnancy, confirmed by a positive hCG laboratory test. 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. -
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm 1: Steroids
Arm 2: Anakinra
Treatment with prednisone will be initiated at a dosage of 1 mg/kg/day (maximum 50 mg/day) in twice daily administration for 14 days. In case of complete response to treatment, prednisone will be reduced from day 14, otherwise it will be continued at 1 mg/kg/day until day 28 (week 4). Patients with complete response at day 28 will continue the study entering part 2, in which therapy will be progressively tapered. In part 2, prednisone will be tapered progressively by 0.1-0.15 mg/kg/day of prednisone (or 5 mg in patients on the maximum dose of 50 mg/day) from current treatment every week until the break. If there is no relapse, treatment will be discontinued over a 10-week period. Patients will then be evaluated every 4 weeks until the end of the study (week 24).
Treatment with anakinra will be initiated at a dose of 2 mg/kg/day (maximum dose 100 mg/day) as a single daily dose and maintained until day 28 (week 4). Patients who achieve a complete treatment response at week 4 (day 28) will continue the study into Part 2. Patients without a complete treatment response will drop out of the study. In Part 2 patients will continue daily anakinra treatment through week 12. The treatment will then be progressively reduced through the reduction of one weekly administration of the drug. The reductions will be made every 2 weeks until the interruption. Therefore, if no relapse occurs, treatment will be discontinued at week 24.