Clinical Features and Treatment of Systemic JIA in Children (CST-SJIA)

September 10, 2026 updated by: Amira Gamal Mohammed Ahmed, Sohag University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Drug: Tocilizumab (Actemra®)

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Amira Gamal Mohammed, Master's degree
Phone Number: 01015797592
Email: merogamal005@gmail.com

Study Locations

Egypt
- - Sohag, Egypt
    - Sohag University Hospital
    - Contact:
      
      Amira Gamal Mohammed
      
      Phone Number: 01015797592
      
      Email: merogamal005@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of children younger than 18 years of age diagnosed with systemic juvenile idiopathic arthritis (sJIA) according to the 2019 PRINTO classification criteria. Participants will be recruited from the pediatric rheumatology service and followed prospectively to assess their clinical course, disease activity, response to treatment, treatment-related outcomes, and disease complications.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline and at 1, 3, 6, 9, and 12 months after treatment initiation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

Principal Investigator: Amira Gamal Mohammed, Master, Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

August 31, 2026

First Submitted That Met QC Criteria

September 10, 2026

First Posted (Actual)

September 11, 2026

Study Record Updates

Last Update Posted (Actual)