- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Amira Gamal Mohammed, Master's degree
- Numéro de téléphone: 01015797592
- E-mail: merogamal005@gmail.com
Lieux d'étude
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Sohag, Egypte
- Sohag university hospital
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Contact:
- Amira Gamal Mohammed
- Numéro de téléphone: 01015797592
- E-mail: merogamal005@gmail.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Disease Activity in Children with Systemic Juvenile Idiopathic Arthritis
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Amira Gamal Mohammed, Master, Sohag University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Soh-Med-26-6-10MS
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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