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- Klinische proef NCT07814963
Clinical Features and Treatment of Systemic JIA in Children (CST-SJIA)
Clinical Characterization and Different Therapeutic Modalities in Children With Systemic Juvenile Idiopathic Arthritis
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Amira Gamal Mohammed, Master's degree
- Telefoonnummer: 01015797592
- E-mail: merogamal005@gmail.com
Studie Locaties
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Sohag, Egypte
- Sohag university hospital
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Contact:
- Amira Gamal Mohammed
- Telefoonnummer: 01015797592
- E-mail: merogamal005@gmail.com
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Disease Activity in Children with Systemic Juvenile Idiopathic Arthritis
Tijdsspanne: At baseline and at 1, 3, 6, 9, and 12 months after treatment initiation.
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Disease activity will be assessed using the Juvenile Arthritis Disease Activity Score-10 (JADAS-10) at baseline and during follow-up after treatment initiation.
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At baseline and at 1, 3, 6, 9, and 12 months after treatment initiation.
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Amira Gamal Mohammed, Master, Sohag University
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Soh-Med-26-6-10MS
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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