NCT05382715终止不适用
Ulcerative Colitis in Subjects of Clinical Routine: A Four Year, Multicenter, Prospective, Non-Interventional Study to Evaluate Utilization, Effectiveness, and Quality of Life With Ozanimod
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2022年5月30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
- 终止
- 发起方
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Number of participants with Clinical Remission, defined by a partial Mayo Score (pMayo) of ≤1 plus an RBS=0
研究概览
简要总结
The purpose of this study is to monitor the use, effectiveness and treatment persistence with Ozanimod (Zeposia®) as well as quality of life in participants undergoing treatment for moderate-to-severe ulcerative colitis (UC).
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
- •Only Ozanimod (Zeposia®) naïve participants can be included into this prospective study
- •Participants are suitable for therapy with Ozanimod (Zeposia®) according to the physician's recommendation (made before enrollment and independently of this Non-Interventional Study (NIS))
- •Treatment with Ozanimod (Zeposia®) must be in-label and follow the approved Summary of Product Characteristics (SmPC)
- •Participants must have confirmed diagnosis of moderate-to-severe Ulcerative Colitis
排除标准
- •Participants that have previously been treated with Ozanimod (Zeposia®)
- •Participants with mild Ulcerative Colitis (UC)
- •Participants with a stoma
- •Participants participating in other clinical trials
- •Participants with a planned surgical intervention and hospitalization due to UC
- •Participants with any contraindications specified in the current version of the SmPC
- •Other protocol-defined Inclusion/Exclusion Criteria apply.
研究组 & 干预措施
Cohort 1
干预措施: Ozanimod (Drug)
结局指标
主要结局
Number of participants with Clinical Remission, defined by a partial Mayo Score (pMayo) of ≤1 plus an RBS=0
时间窗: At week 10
次要结局
- Persistence of therapy during the study course measured by the number of participants who are on continuous treatment(Up to Week 52)
- Number of participants with Clinical Response(At Week 10 and Week 52)
- Number of participants with Clinical Remission(Up to Week 52)
- Number of participants with clinical remission at week 52 in patients who showed clinical response at week 10(Up to Week 52)
- Treatment modalities measured by the Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9)(Up to 1 Year)
- Patient's satisfaction with therapy measured by the TSQM-9(Up to 1 Year)
- Time to discontinuation of treatment(Up to 1 Year)
- Change from baseline in Patient-Reported Outcomes (PROs) with regards to fatigue measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)(Up to 1 Year)
- Change from baseline in PROs with regards to quality of life measured by the Short Inflammatory Bowel Disease Questionnaire (sIBDQ)(Up to 1 Year)
- Number of participants with Adverse Events (AEs)(Up to 1 Year)
- Number of participants with CS-Free clinical remission(Up to 1 Year)
- Number of participants with Corticosteroid (CS)-Free clinical response(Up to 1 Year)
研究者
研究点 (1)
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