2023-504756-96-00招募中3 期
Therapeutic approach in Colchicine-resistant Recurrent pEricarditis in children: an open-label randomized trial comparing Anakinra vs sTEroids
Giannina Gaslini Institute For Scientific Hospitalization And Care15 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2023年10月23日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 15
- 主要终点
- Complete response of disease flare at day 7
研究概览
简要总结
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.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Complete response of disease flare at day 7
Complete response of disease flare at day 7
Lack of relapse at month 3
Lack of relapse at month 3
次要结局
- Time to achieve a complete control of the flare
- Time to flare after treatment tapering
- Number of flares at follow up
- Behavior of acute phase reactants during 6 months of observation
- Quality of life
- Safety (registration of side effects occurred during the whole period of the study)
- Number of day of hospitalization
- Transcriptomic study
研究者
Roberta Caorsi
Scientific
Giannina Gaslini Institute For Scientific Hospitalization And Care
研究点 (15)
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