2025-524573-16-00招募中4 期
OPTIMAL CARE WITH GUSELKUMAB IN CROHN’S DISEASE
i-GETAID31 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2026年4月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 31
- 主要终点
- Steroid free clinical remission (SFCR) associated with fecal calprotectin < 250 ug/g at W48
研究概览
简要总结
To evaluate the one-year effectiveness of GUS in CD in real-world setting
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of Crohn's disease according to ECCO guidelines
- •Absence of contraindication to guselkumab
- •Active disease according to PRO2 (abdominal pain > 1 or stool frequency > 3), and faecal calprotectin > 250 ug/g
- •Objective active disease (as defined by endoscopy, MRI or IUS) within ≤ 2 month
- •18 years of age or older at the time of informed consent
- •Not currently participating in any interventional research
- •Naïve or exposed to one or more advanced therapy
排除标准
- •Previous exposure to an anti-IL23
- •Combination of an advanced therapy with guselkumab
- •Patient with ostomy
- •Pregnant or breastfeeding woman
- •Patient with perianal Crohn's disease predominant disease
- •Patients under legal protection
研究组 & 干预措施
Guselkumab - solution for injection in pre-filled syringe - 100 mg/mL, Guselkumab
Test
干预措施: Guselkumab (Drug)
Guselkumab - solution for injection in pre-filled syringe - 100 mg/mL, Guselkumab
Test
干预措施: Guselkumab - solution for injection in pre-filled syringe - 100 mg/mL (Drug)
结局指标
主要结局
Steroid free clinical remission (SFCR) associated with fecal calprotectin < 250 ug/g at W48
Steroid free clinical remission (SFCR) associated with fecal calprotectin < 250 ug/g at W48
次要结局
- Morphological remission at W48 assessed using the same tool that was used for the patient’s inclusion: endoscopy, MRI or IUS (major secondary endpoint)
- SFCR associated with fecal calprotectin < 250 ug/g at W12, W24 and W48
- Clinical remission at W12, W24, and W48
- Clinical response at W12
- Biomarker remission at W12, W24, and W48
- Need for guselkumab dose intensification (W12, W24, W48)
- Change in Short IBD-Q (quality of life index) from baseline (W12, W24, and W48)
研究者
MATHURIN FUMERY
Scientific
i-GETAID
研究点 (31)
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