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Therapeutic approach in Colchicine-resistant Recurrent pEricarditis in children: an open-label randomized trial comparing Anakinra vs sTEroids
EU CTIS ID: 2023-504756-96-00
What this study is testing
Main objective of this study is to demonstrate that anakinra is more effective than steroids to control the disease and prevent further flares in paediatric (from 8 months to < 18 years) patients with RP not responding to first line treatment with NSAIDS and colchicine at the proper dosage, or in case of colchicine intolerance.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and female patients, from 8 months to less than 18 years
- 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
You likely can't join if
- Pericarditis secondary to a known infection (viral, bacterial, mycobacterial)
- 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: Neutropenia (absolute neutrophil count <1000/mmc), Thrombocytopenia (platelets <100.000/mmc) or Severe anaemia (Hb < 7.5 mg/dl)
- 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
- Presence of laboratory or echocardiographic findings of myopericarditis
See the full eligibility criteria
- Male and female patients, from 8 months to less than 18 years
- 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
- Pericarditis secondary to a known infection (viral, bacterial, mycobacterial)
- 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: Neutropenia (absolute neutrophil count <1000/mmc), Thrombocytopenia (platelets <100.000/mmc) or Severe anaemia (Hb < 7.5 mg/dl)
- 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
- Presence of laboratory or echocardiographic findings of myopericarditis
- 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
- Pericarditis in a patient with a previous diagnosis of any neoplasm and without complete recovery from at least one year
- Patients fulfilling diagnostic criteria for an autoimmune systemic disease
- Patients with a previous diagnosis of a genetically confirmed autoinflammatory disease
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.