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De klinische studie NCT05925452 voor Active Systemic Juvenile Idiopathic Arthritis is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
Eén studie komt overeen met de filtercriteria
Kaartweergave
To Evaluate the Efficacy and Safety of Genalumab for Injection in the Treatment of Active Systemic Juvenile Idiopathic Arthritis. 221 Gerandomiseerd
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De klinische studie NCT05925452 is een interventioneel studie bij Active Systemic Juvenile Idiopathic Arthritis met de status rekruterend. Het doel is om 221 deelnemers te includeren vanaf 1 december 2023. De studie wordt geleid door Changchun GeneScience Pharmaceutical Co., Ltd. en de voltooiing is gepland op 29 juni 2028. Laatste update op ClinicalTrials.gov: 23 september 2024.
Beknopte samenvatting
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.
Officiële 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.
Aandoeningen
Active Systemic Juvenile Idiopathic ArthritisPublicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:Andere studie-ID's
- GenSci048-201
NCT-ID
Startdatum (Werkelijk)
2023-12-01
Laatste update geplaatst
2024-09-23
Verwachte einddatum
2028-06-29
Inschrijving (Geschat)
221
Studietype
Interventioneel
FASE
N.v.t.
Status
Rekruterend
Primaire doel
Behandeling
Toewijzing
N.v.t.
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelGenaKumab 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 |
Primaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Proportion of subjects with successful glucocorticoid reduction by the end of the treatment period | 24 Week |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Kind
Minimumleeftijd
2 Years
Geslachten die in aanmerking komen voor de studie
Allen
- 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.Centraal Contactpersoon
Contact: Lijun Tang, +86 18570616501, [email protected]
10 Studielocaties in 1 landen
Benjing
Children's Hospital Affiliated to Capital Medical University, Beijing, Benjing, 100045, China
Caifeng Li, Doctor, Contact, +86-10-59616316, [email protected]
Rekruterend
Chongqing Municipality
Children's Hospital Affiliated to Chongqing Medical University, Chongqing, Chongqing Municipality, 400015, China
Xuemei Tang, Doctor, Contact, +86-0731-85356314, [email protected]
Nog niet rekruterend
Hunan
Hunan Children's Hospital, Changsha, Hunan, 410323, China
Zhihui Li, Doctor, Contact, +86-023-68370205, [email protected]
Nog niet rekruterend
Jiangsu
Children's Hospital Affiliated to Nanjing Medical University, Nanjing, Jiangsu, 210008, China
Qihua Feng, Doctor, Contact, +86-0521-80698511, [email protected]
Nog niet rekruterend
Children's Hospital of Soochow University, Suzhou, Jiangsu, 215002, China
Cuihua Liu, Doctor, Contact, +86- 0371-85515853, [email protected]
Nog niet rekruterend
Shanghai Municipality
Affiliated Pediatric Hospital of Fudan University, Shanghai, Shanghai Municipality, 201102, China
Li Sun, Doctor, Contact, +86-021-64931990, [email protected]
Nog niet rekruterend
Shanxi
Xi'an Children's Hospital, Xi’an, Shanxi, 710002, China
Xiaoqing Zuo, Doctor, Contact, +86-029- 87692043, [email protected]
Nog niet rekruterend
Sichuan
Chengdu Women and Children's Central Hospital, Chengdu, Sichuan, 610073, China
Wenjie Zheng, Doctor, Contact, +86-0557-81732562, [email protected]
Nog niet rekruterend
Zhejiang
Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310016, China
Meiping Lu, Doctor, Contact, +86-0571- 81732562, [email protected]
Nog niet rekruterend
The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325099, China
Haiguo Yu, Doctor, Contact, +86-025-8311750, [email protected]
Nog niet rekruterend