Trial Radar KI | ||
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Die klinische Studie NCT05925452 für Active Systemic Juvenile Idiopathic Arthritis ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
To Evaluate the Efficacy and Safety of Genalumab for Injection in the Treatment of Active Systemic Juvenile Idiopathic Arthritis. 221 Randomisiert
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT05925452 ist eine interventionsstudie zur Untersuchung von Active Systemic Juvenile Idiopathic Arthritis und hat den Status offene rekrutierung. Die Studie startete am 1. Dezember 2023 und soll 221 Teilnehmer aufnehmen. Durchgeführt von Changchun GeneScience Pharmaceutical Co., Ltd. ist der Abschluss für 29. Juni 2028 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 23. September 2024 aktualisiert.
Kurzbeschreibung
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.
Offizieller Titel
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.
Erkrankungen
Active Systemic Juvenile Idiopathic ArthritisPublikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:Weitere Studien-IDs
- GenSci048-201
NCT-Nummer
Studienbeginn (tatsächlich)
2023-12-01
Zuletzt aktualisiert
2024-09-23
Studienende (vorauss.)
2028-06-29
Geplante Rekrutierung
221
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellGenaKumab 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 |
Hauptergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Proportion of subjects with successful glucocorticoid reduction by the end of the treatment period | 24 Week |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Kind
Mindestalter
2 Years
Zugelassene Geschlechter
Alle
- 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.Zentrale Studienkontakte
Kontakt: Lijun Tang, +86 18570616501, [email protected]
10 Studienstandorte in 1 Ländern
Benjing
Children's Hospital Affiliated to Capital Medical University, Beijing, Benjing, 100045, China
Caifeng Li, Doctor, Kontakt, +86-10-59616316, [email protected]
Offene Rekrutierung
Chongqing Municipality
Children's Hospital Affiliated to Chongqing Medical University, Chongqing, Chongqing Municipality, 400015, China
Xuemei Tang, Doctor, Kontakt, +86-0731-85356314, [email protected]
Noch nicht rekrutierend
Hunan
Hunan Children's Hospital, Changsha, Hunan, 410323, China
Zhihui Li, Doctor, Kontakt, +86-023-68370205, [email protected]
Noch nicht rekrutierend
Jiangsu
Children's Hospital Affiliated to Nanjing Medical University, Nanjing, Jiangsu, 210008, China
Qihua Feng, Doctor, Kontakt, +86-0521-80698511, [email protected]
Noch nicht rekrutierend
Children's Hospital of Soochow University, Suzhou, Jiangsu, 215002, China
Cuihua Liu, Doctor, Kontakt, +86- 0371-85515853, [email protected]
Noch nicht rekrutierend
Shanghai Municipality
Affiliated Pediatric Hospital of Fudan University, Shanghai, Shanghai Municipality, 201102, China
Li Sun, Doctor, Kontakt, +86-021-64931990, [email protected]
Noch nicht rekrutierend
Shanxi
Xi'an Children's Hospital, Xi’an, Shanxi, 710002, China
Xiaoqing Zuo, Doctor, Kontakt, +86-029- 87692043, [email protected]
Noch nicht rekrutierend
Sichuan
Chengdu Women and Children's Central Hospital, Chengdu, Sichuan, 610073, China
Wenjie Zheng, Doctor, Kontakt, +86-0557-81732562, [email protected]
Noch nicht rekrutierend
Zhejiang
Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310016, China
Meiping Lu, Doctor, Kontakt, +86-0571- 81732562, [email protected]
Noch nicht rekrutierend
The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325099, China
Haiguo Yu, Doctor, Kontakt, +86-025-8311750, [email protected]
Noch nicht rekrutierend