DRKS00040482进行中（未招募）不适用
PharmocogenOmics for minimized Risk and better Efficacy in Children on high-dose Steroid Treatment - PhORECaST
Universitätsklinikum Carl Gustav Carus Dresden an der Technischen Universität Dresden0 个研究点目标入组 200 人开始时间: 2026年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 28 Days 至 18 Years（—）
- 性别
- All
入选标准
- •The study population includes children and adolescents from the 29th day of life up to 18 years of age with an acute immune-mediated disease who are receiving high-dose glucocorticoid pulse therapy based on a medical indication. In addition, parents or legal guardians will be invited to participate in the parent proxy assessment.
- •Inclusion criteria
- •Patients are eligible to participate if they meet all of the following criteria:
- •Age: from the 29th day of life up to 18 years; participation in the EMA assessment from 8 years of age.
- •Diagnostic categories (grouped):
- •Rheumatologic diseases: juvenile idiopathic arthritis (polyarticular, systemic), juvenile systemic lupus erythematosus (SLE), non-infectious uveitis, dermatomyositis/connective tissue diseases, autoinflammatory diseases, vasculitis with organ involvement.
- •Neurological diseases: central nervous system vasculitis, acute demyelinating diseases (ADEM, CIS, POMS), MOGAD, NMOSD, (LE)TM, autoimmune encephalitis (NMDAR antibodies, GABAA antibodies, LGI1 antibodies, CASPR2 antibodies).
- •Gastrointestinal diseases: severe flares of inflammatory bowel disease.
- •Nephrological diseases: nephrotic syndrome.
- •Allergic/systemic reactions.
- •Medical indication for high-dose glucocorticoid pulse therapy according to physician decision.
- •Medication status: no systemic glucocorticoid treatment within the previous 8 weeks.
- •Consent: written informed consent from parents or legal guardians.
- •Availability: availability for follow-up assessments over a period of 3 months.
排除标准
- •Patients will be excluded if any of the following criteria apply:
- •Chronic or severe comorbidities: cytostatic drugs/chemotherapy, biologicals associated with marked lymphocyte depletion (e.g. rituximab), primary immunodeficiencies, organ transplantation, malignant diseases.
- •Active infections: bacterial sepsis, meningitis, endocarditis, bacterial pneumonia, osteomyelitis/septic arthritis, varicella infection, herpes simplex virus (HSV) infection without a compelling indication for glucocorticoid treatment.
- •Medication-related contraindications: systemic glucocorticoid therapy within the previous 8 weeks.
- •Other criteria: pregnancy, lack of informed consent, insufficient sample volume for analyses, or inability to participate in follow-up assessments during the 3-month observation period after enrolment.
研究者
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