An Observational, Multicenter Study to Evaluate the Effectiveness of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection
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: Guselkumab.
- Кому может быть актуально
- Состояния в реестре: Crohn's Disease (CD). Базовые параметры: от 18 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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Обзор
The goal of this single arm ,non-interventional, prospective, descriptive study is to evaluate the efficacy of guselkumab treatment in preventing endoscopic recurrence of Crohn's Disease in adult participants who have a documented diagnosis of moderate to severe CD and have undergone an ileocolonic surgical resection. The primary endpoint is Endoscopic recurrence rate at week24.
Подробное описание
This is an open-labeled, single arm, non-interventional, prospective, descriptive study, planned to include postoperative CD patients. After ileocolonic surgical resection, the patients who are treated with GUS will be enrolled in this study. The period is 48 weeks. The primary endpoint is Endoscopic recurrence （modified Rutgeerts score ≥ i2b）at Wk 24. IA is planned to be conducted when 30% of the enrolled patients have finished 24wk follow up. The Secondary endpoint are Clinical remission without recurrence（CDAI \< 150）at Wk24/Wk48;Endoscopic recurrence at Wk48 (modified Rutgeerts score ≥ i2b);Endoscopic remission（SES-CD≤3）at Wk24/48;Safety profile. Exploratory endpoint includes histologic score (Geboes scale/RHI/GHAS) at Wk24/48 ileocolonoscopy; time to endoscopic recurrence; time to recurrence of symptoms; endoscopic recurrence rate at Wk24/48(POCER)
Вмешательства
- Препарат Guselkumab
Guselkumab is an IL23 p19 subunit antagonist that binds to IL-23 with high affinity and potency and also binds to the CD64 receptor (high affinity Fcγ receptor 1) on the surface of human inflammatory monocytes, which enables it to neutralize IL-23 at its predominant source of production, potentially enriching the presence of guselkumab in the inflamed tissue microenvironment.GALAXI and GRAVITI studies have demonstrated that Guselkumab treatment was both safe and effective for induction and maint
Первичные конечные точки
- Endoscopic recurrence rate at Wk 24 [Срок оценки: From enrollment to Week 24]
Вторичные конечные точки (4)
- Clinical remission without recurrence at Wk24/Wk48 [Срок оценки: From enrollment to Wk48]
- Endoscopic recurrence at Wk48 [Срок оценки: From enrollment to Wk48]
- Endoscopic remission at Wk24/48 [Срок оценки: From enrollment to Wk48]
- Safety profile [Срок оценки: From enrollment to Wk48]
Критерии участия
Критерии включения
- Patients≥ 18，
- Have a documented diagnosis of moderate to severe CD
- Have undergone an ileocolonic surgical resection
Критерии исключения
- Has complications of CD, such as short bowel syndrome Currently has or is suspected to have an abscess
- Active infection
- Currently has a malignancy or has a history of malignancy within 5 years
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 1 центр
- Shanghai 10th People's Hospital, Tongji University School of Medicine — Шанхай
Идентификаторы
NCT: NCT07528040 · SHSY-IEC-6.0/26K44/P01