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NCT Number: NCT07814963

Clinical Features and Treatment of Systemic JIA in Children

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Tocilizumab (Actemra®)

Drug

Tocilizumab used as part of routine clinical care for the management of systemic juvenile idiopathic arthritis. The treatment regimen, duration, and clinical response will be documented according to the treating physician's clinical practice.

Primary outcomes

  1. Disease Activity in Children with Systemic Juvenile Idiopathic Arthritis

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amira Gamal Mohammed, Master's degree

CONTACT

[email protected]

01015797592

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Acronym: CST-SJIA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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