NCT06073873招募中不适用
Post-Marketing Surveillance (PMS) Study on Zeposia® (Ozanimod) Use Among Moderate to Severe Active Ulcerative Colitis Patients in Korea
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2024年4月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
The purpose of this observational study is to assess the real-world safety of ozanimod in Korean participants with moderate to severe active ulcerative colitis.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants 19 years of age or older
- •Participants who will receive ozanimod according to the approved label after enrollment
- •Participants who sign the informed consent form voluntarily
排除标准
- •Participants who are prescribed ozanimod for therapeutic indications not approved in Korea
- •Participants for whom ozanimod is contraindicated as clarified in Korean prescribing information approved by Ministry of Food and Drug Safety
研究组 & 干预措施
Participants with moderate to severe active ulcerative colitis treated with ozanimod
干预措施: Ozanimod (Drug)
结局指标
主要结局
Adverse events
时间窗: Up to 52 weeks
The type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs for ozanimod
次要结局
未报告次要终点
研究者
研究点 (1)
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