Effectiveness and Safety of Treatment With Vedolizumab in Adult Patients With Ulcerative Colitis or Crohn's Disease in Real Life
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 29
- 试验地点
- 13
- 主要终点
- Number of Participants With Complete Steroid-free Clinical Remission at Month 24
研究概览
简要总结
The purpose of this study is to describe in real life the effectiveness of treatment with vedolizumab.
详细描述
This is a prospective, non-interventional and pharmaco-epidemiological study of participants with IBD. The study will provide the real-life data of treatment effectiveness and safety of vedolizumab in adult participants with UC or CD.
The study will enroll approximately 300 participants. All participants will be enrolled in one observational group:
Vedolizumab
Data will be collected and observed for 24 months in the participants who will be freely chosen by physicians to prescribe vedolizumab at the end of consultation in the recruitment period.
This multi-center trial will be conducted in France. The overall time to participate in this study is 36 months, including participant's recruitment period of 12 months and treatment period of 24 months. Participants will make a minimum of 4 follow-up visits to the clinic in treatment period at Month 6, 12, 18, and 24.
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
- •Suffering from active disease of UC or CD according to the investigator's judgment.
- •In failure or intolerant to a previous biologic treatment, or with contra-indication to anti-TNFalpha after failure of conventional treatments, regardless of the line of treatment.
- •Meeting the same criteria as those described at the pre-screening.
- •Prescription of vedolizumab during consultation.
- •Able to be followed a priori over a period of 24 months.
排除标准
- •With exclusion criteria for vedolizumab and any contra-indication to vedolizumab: hypersensitivity to the active substance or to any of its excipients, active severe infections, such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as progressive multifocal leukoencephalopathy (PML).
- •Participation in an interventional study (but not in another non-interventional study).
- •Unclassified colitis.
结局指标
主要结局
Number of Participants With Complete Steroid-free Clinical Remission at Month 24
时间窗: Month 24
Clinical remission is defined as Harvey Bradshaw-index (HBI) score less than or equal to (\<=) 4 and partial mayo clinic score \<=3. HBI score is used to measure disease activity of CD. It consists of clinical parameters: general well-being (0-4), abdominal pain (0-3), number of liquid stools per day, abdominal mass (0-3), and complications (score 1 per item). Total score is sum of individual parameters. Score ranges from minimum score of 0 to no pre-specified maximum score as it depends on number of liquid stools, where higher scores means more severe disease. Mayo score is an instrument designed to measure disease activity of UC and consists of 3 sub scores: stool frequency, rectal bleeding, and physician rating of disease activity, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9; where higher scores means more severe disease.
次要结局
- Number of Non-naïve Participants Ineligible to Anti TNF Alpha(Baseline up to Month 24)
- Number of Participants With Concordance Between PRO-2 and Physicians Answers(Baseline up to 24 Months)
- Number of Participants who had Surgery(Baseline up to Month 24)
- Number of Participants who had Complications due to Adverse Events (AEs)(Baseline up to Month 24)
- Number of Participants with Mucosal Healing Having Undergone Endoscopy(Months 6, 12, 18 and 24)
- Duration of Treatment in Participants Treated with Vedolizumab(Baseline up to Month 24)
- Number of Treatment Lines in Participants Treated with Vedolizumab(Baseline up to Month 24)
- Number of Naïve Participants Ineligible to Anti TNF Alpha(Baseline up to Month 24)
- Number of Participants with Special Situation Report (SSR)(Baseline up to Month 24)
- Number of Participants with Markedly Abnormal Laboratory Values(Baseline up to Month 24)
- Patient Reported Outcomes (PRO) 1: Quality of Life(Months 6, 12, 18 and 24)
- Number of Participants who had Relapses(Baseline up to Month 24)
- Number of Participants who had Treatment Failure When Treated With Vedolizumab(Baseline up to Month 24)
- Number of Participants who Experience at Least one Treatment-emergent Adverse Event (TEAE)(Baseline up to Month 24)
- Number of Participants with Complete Steroid-free Remission at Month 6, 12 and 18(Months 6, 12, and 18)
- Number of Participants with Non-serious Adverse Drug Reactions (ADRs)(Baseline up to Month 24)
- Number of Participants who had Hospitalizations(Baseline up to Month 24)
- Number of Participants who had Absenteeism(Baseline up to Month 24)
- Number of Participants with Vedolizumab Effectiveness on Extra-intestinal Manifestations or Fistula(Baseline up to Month 24)
- Percentage of Physicians Following the French National Consensus for the Management of IBD into Clinical Practice(Baseline up to Month 24)
- Number of Participants with Product Quality Issues(Baseline up to Month 24)
- PRO 2: Number of Participants who met Item 1 and 2 on the Partial Mayo Score and Item 2 and 3 on the HBI(Months 6, 12, 18 and 24)
- Number of Participants with Comorbodities, Previous Line of Therapy and Concomitant Treatments(Baseline up to Month 24)