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临床试验/NCT07814963
NCT07814963尚未招募不适用

Clinical Characterization and Different Therapeutic Modalities in Children With Systemic Juvenile Idiopathic Arthritis

Sohag University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年10月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
Disease Activity in Children with Systemic Juvenile Idiopathic Arthritis

研究概览

简要总结

This study aims to describe the clinical features, disease patterns, and different treatment modalities used in children with systemic juvenile idiopathic arthritis (sJIA). The study will include children younger than 18 years who meet the established classification criteria for sJIA. Clinical findings, laboratory investigations, disease activity, complications, and treatments received will be assessed. Participants will be followed prospectively to evaluate their clinical course and response to different therapeutic approaches. The study will help improve understanding of sJIA in children and provide information about the outcomes associated with different treatment modalities.

详细描述

Systemic juvenile idiopathic arthritis (sJIA) is a chronic inflammatory disease of childhood characterized by systemic manifestations such as recurrent fever, evanescent rash, lymphadenopathy, hepatosplenomegaly, and serositis, with or without arthritis. The disease may have a variable clinical course and can be associated with significant complications, including macrophage activation syndrome (MAS).

This study aims to clinically characterize children with sJIA and describe the different therapeutic modalities used in their management. The study will include children younger than 18 years who fulfill the 2019 PRINTO classification criteria for systemic juvenile idiopathic arthritis.

Clinical and laboratory data will be collected, including demographic characteristics, presenting manifestations, disease activity, inflammatory markers, relevant laboratory investigations, complications, and treatment modalities. Information regarding corticosteroids, conventional disease-modifying antirheumatic drugs, and biologic therapies will be documented according to the treatment received as part of routine clinical care.

Participants will be followed prospectively to assess their clinical course, disease activity, response to treatment, treatment-related outcomes, and occurrence of complications. The study is observational; treatment decisions will not be assigned by the study protocol and will remain according to the treating physician's clinical judgment.

The study will provide a clinical characterization of sJIA in children and describe outcomes associated with the different therapeutic modalities used in routine clinical practice.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children aged <18 years.
  • Children diagnosed with systemic juvenile idiopathic arthritis (sJIA) according to the 2019 PRINTO classification criteria.
  • Both newly diagnosed and previously diagnosed children with sJIA attending the study center.

排除标准

  • Children with other rheumatic or autoimmune diseases.
  • Children with infectious, malignant, or other systemic diseases that may mimic sJIA.
  • Patients whose medical records have insufficient data for assessment.

结局指标

主要结局

Disease Activity in Children with Systemic Juvenile Idiopathic Arthritis

时间窗: At baseline and at 1, 3, 6, 9, and 12 months after treatment initiation.

Disease activity will be assessed using the Juvenile Arthritis Disease Activity Score-10 (JADAS-10) at baseline and during follow-up after treatment initiation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amira Gamal Mohammed Ahmed

Pediatrics Resident at sohag university hospital

Sohag University

研究点 (1)

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