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L'essai clinique NCT05925452 pour Active Systemic Juvenile Idiopathic Arthritis est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Vue en carte
To Evaluate the Efficacy and Safety of Genalumab for Injection in the Treatment of Active Systemic Juvenile Idiopathic Arthritis. 221 Randomisé
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT05925452 est une étude interventionnel pour Active Systemic Juvenile Idiopathic Arthritis. Son statut actuel est : en recrutement. L'étude a débuté le 1 décembre 2023 et vise à recruter 221 participants. Dirigée par Changchun GeneScience Pharmaceutical Co., Ltd., l'étude devrait être terminée d'ici le 29 juin 2028. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 23 septembre 2024.
Résumé succinct
A multicenter, randomized Phase II/III clinical study to evaluate the efficacy and safety of GenaKumab in the treatment of active systemic juvenile idiopathic arthritis.
Titre officiel
A Multicenter, Randomized Phase II/III Clinical Study to Evaluate the Efficacy and Safety of GenaKumab in the Treatment of Active Systemic Juvenile Idiopathic Arthritis.
Pathologies
Active Systemic Juvenile Idiopathic ArthritisPublications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:Autres identifiants de l'étude
- GenSci048-201
Numéro NCT
Date de début (réel)
2023-12-01
Dernière mise à jour publiée
2024-09-23
Date de fin (estimée)
2028-06-29
Inscription (estimée)
221
Type d'étude
Interventionnel
PHASE
N/A
Statut
En recrutement
Objectif principal
Traitement
Méthode d'allocation
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalGenaKumab 15 subjects: GenaKumab 3.0mg/kg dose group and 4.0 mg/kg dose group, Subcutaneous injection, Q4w | GenaKumab GenaKumab 3.0mg/kg dose group : GenaKumab 3.0 mg/kg, Subcutaneous injection, Q4w； GenaKumab 4.0 mg/kg dose group : GenaKumab 4.0 mg/kg, Subcutaneous injection, Q4w |
Critère principal d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Proportion of subjects with successful glucocorticoid reduction by the end of the treatment period | 24 Week |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Enfant
Âge minimum
2 Years
Sexes éligibles
Tous
- Male and female patients, with the remaining before age 2 years old or more and & lt; 18 years old;
- 2001 ILAR classification criteria for the diagnosis of confirmed sJIA 2 or more months: onset age must & lt; At 16 years of age, symptoms included: ≥1 case of arthritis, accompanied by or prior to ≥2 weeks of recurrent fever, including remittenor fever for ≥3 consecutive days (maximum daily body temperature ≥39 ° C, body temperature falling below 37 ° C between 2 heat peaks), accompanied by at least one of the following symptoms: ① a transient, non-fixed erythematous rash; ② systemic lymph node enlargement; Swelling of the liver and/or spleen; ④ Serositis.
- Agree to use effective means of contraception throughout the study period and for 6 months after the end of treatment.
- Pregnant or lactating female subjects
- A history of allergic reactions to investigational drugs or to molecules with similar structures; Those who cannot be given intramuscular injections；
- History of pericarditis, myocarditis, serositis, bacterial heart valve or endocarditis within 6 months before screening; Patients who had been diagnosed with MAS within 6 months prior to screening, or had relevant symptoms and signs at screening, and were suspected of having MAS as assessed by the investigators；
- There are other rheumatic diseases such as Kawasaki disease, polyarteritis nodosa and so on. History of autoinflammatory diseases such as familial Mediterranean fever, high IgD syndrome, NLRP3-related autoinflammatory diseases；
- Patients with a history of interstitial lung disease, pulmonary fibrosis, alveolar proteinosis, or pulmonary hypertension; Patients with a history of repeated invasive fungal infection; In the 7 days prior to randomization, there were infections that required control with systemic antigenic microbiotics (including antibacterial, antiviral, antifungal, etc.)；
- Subjects with a history of TB exposure or suspected TB symptoms.
Changchun GeneScience Pharmaceutical Co., Ltd.Contact central de l'étude
Contact: Lijun Tang, +86 18570616501, [email protected]
10 Centres de l'étude dans 1 pays
Benjing
Children's Hospital Affiliated to Capital Medical University, Beijing, Benjing, 100045, China
Caifeng Li, Doctor, Contact, +86-10-59616316, [email protected]
En recrutement
Chongqing Municipality
Children's Hospital Affiliated to Chongqing Medical University, Chongqing, Chongqing Municipality, 400015, China
Xuemei Tang, Doctor, Contact, +86-0731-85356314, [email protected]
Pas encore en recrutement
Hunan
Hunan Children's Hospital, Changsha, Hunan, 410323, China
Zhihui Li, Doctor, Contact, +86-023-68370205, [email protected]
Pas encore en recrutement
Jiangsu
Children's Hospital Affiliated to Nanjing Medical University, Nanjing, Jiangsu, 210008, China
Qihua Feng, Doctor, Contact, +86-0521-80698511, [email protected]
Pas encore en recrutement
Children's Hospital of Soochow University, Suzhou, Jiangsu, 215002, China
Cuihua Liu, Doctor, Contact, +86- 0371-85515853, [email protected]
Pas encore en recrutement
Shanghai Municipality
Affiliated Pediatric Hospital of Fudan University, Shanghai, Shanghai Municipality, 201102, China
Li Sun, Doctor, Contact, +86-021-64931990, [email protected]
Pas encore en recrutement
Shanxi
Xi'an Children's Hospital, Xi’an, Shanxi, 710002, China
Xiaoqing Zuo, Doctor, Contact, +86-029- 87692043, [email protected]
Pas encore en recrutement
Sichuan
Chengdu Women and Children's Central Hospital, Chengdu, Sichuan, 610073, China
Wenjie Zheng, Doctor, Contact, +86-0557-81732562, [email protected]
Pas encore en recrutement
Zhejiang
Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310016, China
Meiping Lu, Doctor, Contact, +86-0571- 81732562, [email protected]
Pas encore en recrutement
The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325099, China
Haiguo Yu, Doctor, Contact, +86-025-8311750, [email protected]
Pas encore en recrutement