A Study to Assess the Effectiveness and Safety of Treatment With Vedolizumab in Adult Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD) in Real Life

Study Overview
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Brief Summary
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The purpose of this study is to describe in real life the effectiveness of treatment with vedolizumab.

Detailed Description
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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.

Official Title
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Effectiveness and Safety of Treatment With Vedolizumab in Adult Patients With Ulcerative Colitis or Crohn's Disease in Real Life

Conditions
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Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. Stomy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vedolizumab<br>Participants diagnosed with UC or CD, who fail or are intolerant to a previous biologic treatment or with contra-indication to anti-tumor necrosis factor alpha (TNF alpha) after failure of conventional treatments without exclusion except participant refusal, and were potentially eligible for a treatment with vedolizumab will be observed from the first prescription during consultation over a period of 24 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Complete Steroid-free Clinical Remission at 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. | Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Complete Steroid-free Remission at Month 6, 12 and 18 | Clinical remission is defined as HBI score <=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. | Months 6, 12, and 18 | 
| Duration of Treatment in Participants Treated with Vedolizumab |  | Baseline up to Month 24 | 
| Number of Participants who had Treatment Failure When 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 Non-naïve Participants Ineligible to Anti TNF Alpha |  | 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 Non-serious Adverse Drug Reactions (ADRs) |  | Baseline up to Month 24 | 
| Number of Participants with Special Situation Report (SSR) |  | Baseline up to Month 24 | 
| Number of Participants with Product Quality Issues | A product quality issue refers to defects related to the safety, identity, strength, quality, or purity of the product or with the physical characteristics, packaging, labelling, or design of the product. | 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 | Participant's Quality of Life (PRO-1) will be measured by the inflammatory bowel disease questionnaire (IBDQ). The IBDQ is a 32-item questionnaire that measures 4 dimensions: bowel symptoms (10 items), emotional disorders (12 items), systemic symptoms (5 items), and social function (5 items). Each item is measured according to the Likert technique. Within dimensions, each question presents seven possible answers/points. Each domain score is the sum of 8 responses each ranging from 1 to 7, where 1 indicates worst function and 7 the best. The sub-score ranges from 8 to 56; a higher score indicating a better quality of life. Hence, the total score ranges from 32 to 224, with higher scores representing better quality of life. | Months 6, 12, 18 and 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 Concordance Between PRO-2 and Physicians Answers |  | Baseline up to 24 Months | 
| Number of Participants who had Relapses | Number of participants with relapses will be collected through hospital reports which will be provided by the investigator. | Baseline up to Month 24 | 
| Number of Participants who had Surgery | Number of participants with surgery will be collected through hospital reports which will be provided by the investigator. | Baseline up to Month 24 | 
| Number of Participants who had Complications due to Adverse Events (AEs) |  | Baseline up to Month 24 | 
| Number of Participants who had Hospitalizations | Number of participants with hospitalizations will be collected through hospital reports which will be provided by the investigator. | Baseline up to Month 24 | 
| Number of Participants who had Absenteeism | Number of participants with absenteeism will be collected by the participants using a self-administered questionnaire. | Baseline up to Month 24 | 
| Number of Participants with Vedolizumab Effectiveness on Extra-intestinal Manifestations or Fistula | Number of participants who had effectiveness of vedolizumab on extra-intestinal manifestations or fistula will be assessed. Extra-intestinal manifestations of pathology such as skin, articular, ocular, metabolic, bone, hepato-pancreato-biliary, neurological, cardiovascular diseases and complications related to anal fistula is planned to be assessed. | Baseline up to Month 24 | 
| Number of Participants with Mucosal Healing Having Undergone Endoscopy | Mucosal healing is defined either as the absence of any ulcer (Crohn's Disease Endoscopic Index of Severity [CDEIS] at 0) for CD participants and as a Mayo clinic endoscopic subscore <=1 for UC participants. | Months 6, 12, 18 and 24 | 
| Percentage of Physicians Following the French National Consensus for the Management of IBD into Clinical Practice | 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 Comorbodities, Previous Line of Therapy and Concomitant Treatments |  | Baseline up to Month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug therapy