NCT07606339招募中不适用
Real-world, International, Non-interventional Study of Guselkumab Persistence in Patients With Crohn's Disease and Ulcerative Colitis
Janssen-Cilag Pharma GmbH1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2026年6月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to evaluate how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) in participants with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are inflammatory bowel diseases, a group of inflammatory conditions of the colon and small intestine.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics (SmPC) of drug. Decision to prescribe must solely be made by the treating physician. Enrolment must take place before or on the day of the first administration
- •Confirmed diagnosis of moderate-to-severe UC or CD disease record in their medical records
- •Must sign a participation agreement/informed consent form (ICF) allowing source data verification in accordance with local requirements
排除标准
- •Contraindicated to guselkumab per the label
- •Is currently enrolled in an interventional clinical study
- •Has been previously exposed to interleukin (IL)-23 inhibitors, including Tremfya (guselkumab), Skyrizi (risankizumab) and Omvoh (mirikizumab). As an exception, participants with history of Ustekinumab exposure may be included
- •History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and/or small molecules)
- •Is unable to provide informed consent
研究组 & 干预措施
Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD)
Participants with confirmed diagnosis of moderate to severe crohn's disease (CD) or ulcerative colitis (UC) treated with guselkumab in routine clinical practice will be enrolled. No drug will be provided as a part of this study. Only data available from clinical practice and medical records will be collected within this study.
研究者
研究点 (1)
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