Postmarketing Surveillance Registry to Evaluate Safety and Efficacy of Darvadstrocel for the Treatment of Complex Perianal Fistulas in Crohn's Disease Patients (J-INSPIRE) (All-case Surveillance)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 275
- 试验地点
- 1
- 主要终点
- Percentage of Participants who Achieve Combined Remission
研究概览
简要总结
This study is a survey in Japan of Darvadstrocel injection used to treat Crohn's disease people with complicated anal fistula. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.
The main aim of the study is to check for side effects related from Darvadstrocel injection and to check if Darvadstrocel injection improves symptoms of Crohn's disease. During the study, participants with Crohn's disease will take Darvadstrocel injection according to their clinic's standard practice. The study doctors will check for side effects from Darvadstrocel for 36 months.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Darvadstrocel
Darvadstrocel, 24 mL suspension of 120 million cells as a perilesional injection, once. Participants received interventions as part of routine medical care.
干预措施: Darvadstrocel (Biological)
结局指标
主要结局
Percentage of Participants who Achieve Combined Remission
时间窗: Baseline, Up to Months 36
Combined remission is defined as the clinically confirmed closure of all baseline external openings that were not drained by gentle finger compression with this product treatment, and absence of an abscess greater than or equal to 2 cm in size confirmed by pelvic MRI (if performed) performed within 6 months of this product treatment.
Number of Participants with Adverse Events
时间窗: 36 Months
An adverse event is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product. It does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a pharmaceutical product (including an investigational product for a new indication in Japan), whether or not related to the pharmaceutical product.
Percentage of Participants who Achieve Clinical Response
时间窗: Baseline, Up to Months 36
Clinical Response is defined as the clinically confirmed closure of at least 50% of the fistulas with this product as compared to baseline that were not drained with gentle finger compression.
Percentage of Participants who Achieve Clinical Remission
时间窗: Baseline, Up to Months 36
Clinical remission is defined as the clinically confirmed closure of all fistulas treated with this product as compared to baseline with no discharge despite gentle finger compression.
次要结局
- Percentage of Participants with New Perianal Abscess in a Previously Treated Anal Fistula(Baseline, Up to Months 36)
- Change from Baseline in Perianal Disease Activity Index (PDAI)(Baseline, Up to Months 36)
- Change from Baseline in Harvey Bradshaw Index (HBI: Simple CDAI Score)(Baseline, Up to Months 36)
- HRQOL Measured by Crohn's Anal Fistula Quality of Life (CAF-QoL) Scale(Baseline, Up to Months 36)
- Percentage of Participants who Occurred Recurrence of Previously Treated Anal Fistulas in Participants who Achieved Clinical Remission at the Previous Visit(Baseline, Up to Months 36)
- Health-Related Quality of Life (HRQOL) Measured by EuroQoL Five Dimensions Five Levels (EQ-5D-5L) Scale(Baseline, Up to Months 36)