Systemic Juvenile Idiopathic Arthritis (sJIA)CST-SJIANCT07814963
Clinical Features and Treatment of Systemic JIA in Children
An observational study of Systemic Juvenile Idiopathic Arthritis (sJIA) and Systemic Juvenile Idiopathic Arthritis, run by Sohag University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Systemic Juvenile Idiopathic Arthritis (sJIA), Systemic Juvenile Idiopathic Arthritis
- What is being tested?
- Tocilizumab (Actemra®)
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to 1 Sep 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sohag university hospital
Sohag
Amira Gamal Mohammed, 01015797592, merogamal005@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Tocilizumab (Actemra®)
- Keywords
- sJIA, Systemic juvenile idiopathic arthritis, Juvenile idiopathic arthritis, Pediatric rheumatology
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Activity in Children with Systemic Juvenile Idiopathic Arthritis
Disease activity will be assessed using the Juvenile Arthritis Disease Activity Score-10 (JADAS-10) at baseline and during follow-up after treatment initiation.
Measured: At baseline and at 1, 3, 6, 9, and 12 months after treatment initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Juvenile Idiopathic Arthritis (sJIA)Studies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Gamal Mohammed Ahmed, Sohag University
- Investigators
- Amira Gamal Mohammed, Master, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814963
- Sponsor's protocol ID
- Soh-Med-26-6-10MS
- Acronym
- CST-SJIA
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characterization and Different Therapeutic Modalities in Children With Systemic Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT07814963
- Acronym / sponsor ID
- CST-SJIA / Soh-Med-26-6-10MS
- Keywords
- sJIA, Systemic juvenile idiopathic arthritis, Juvenile idiopathic arthritis, Pediatric rheumatology
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tocilizumab (Actemra®)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. | Drug | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amira Gamal Mohammed, Master principal investigator
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Juvenile Idiopathic Arthritis (sJIA) and Systemic Juvenile Idiopathic Arthritis, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amira Gamal Mohammed, Master's degree (01015797592, merogamal005@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.