Идёт набор NCT05925452
To Evaluate the Efficacy and Safety of Genalumab for Injection in the Treatment of Active Systemic Juvenile Idiopathic Arthritis.
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: GenaKumab.
- Кому может быть актуально
- Состояния в реестре: Active Systemic Juvenile Idiopathic Arthritis. Базовые параметры: 2 лет — 17 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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.
Обзор
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.
Вмешательства
- Препарат 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
Первичные конечные точки
- Proportion of subjects with successful glucocorticoid reduction by the end of the treatment period [Срок оценки: 24 Week]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Китай · 10 центров
- Children's Hospital Affiliated to Capital Medical University — Пекин
- Children's Hospital Affiliated to Chongqing Medical University — Чунцин
- Hunan Children's Hospital — Чанша
- Children's Hospital Affiliated to Nanjing Medical University — Нанкин
- Children's Hospital of Soochow University — Сучжоу
- Affiliated Pediatric Hospital of Fudan University — Шанхай
- Xi'an Children's Hospital — Xi’an
- Chengdu Women and Children's Central Hospital — Чэнду
- … и ещё 2 центра
Публикации
- Li C, Zhang J, Yu H, Lu M, Yang S, Liu C, Zeng P, Zhao B, Li X, Zheng W, Du Y, Zhang W, Li Z, Hu X, Lai J, Xu Q, Zhang X, Wang X, Adili P, Qu W. Efficacy and Safety of Firsekibart in Treatment of Active Systemic Juvenile Idiopathic Arthritis: A Randomized Phase 2 Study. Rheumatol Ther. 2026 Jun;13(3):595-610. doi: 10.1007/s40744-026-00830-9. Epub 2026 Mar 11. PMID 41814037
Идентификаторы
NCT: NCT05925452 · GenSci048-201