Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
Conditions
Keywords
Drug therapy
Brief summary
The purpose of this study is to describe in real life the effectiveness of treatment with vedolizumab.
Detailed description
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.
Interventions
None listed
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Suffering from active disease of UC or CD according to the investigator's judgment. 2. 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. 3. Meeting the same criteria as those described at the pre-screening. 4. Prescription of vedolizumab during consultation. 5. Able to be followed a priori over a period of 24 months.
Exclusion criteria
1. With
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complete Steroid-free Clinical Remission at Month 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline up to Month 24 | 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. |
| 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 | 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. |
| Number of Participants with Complete Steroid-free Remission at Month 6, 12 and 18 | Months 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. |
| Number of Participants With Concordance Between PRO-2 and Physicians Answers | Baseline up to 24 Months | — |
| Number of Participants who had Relapses | Baseline up to Month 24 | Number of participants with relapses will be collected through hospital reports which will be provided by the investigator. |
| Number of Participants who had Surgery | Baseline up to Month 24 | Number of participants with surgery will be collected through hospital reports which will be provided by the investigator. |
| Number of Participants who had Complications due to Adverse Events (AEs) | Baseline up to Month 24 | — |
| Number of Participants who had Hospitalizations | Baseline up to Month 24 | Number of participants with hospitalizations will be collected through hospital reports which will be provided by the investigator. |
| Number of Participants who had Absenteeism | Baseline up to Month 24 | Number of participants with absenteeism will be collected by the participants using a self-administered questionnaire. |
| Number of Participants with Vedolizumab Effectiveness on Extra-intestinal Manifestations or Fistula | Baseline up to Month 24 | 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. |
| Number of Participants with Mucosal Healing Having Undergone Endoscopy | Months 6, 12, 18 and 24 | 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. |
| Percentage of Physicians Following the French National Consensus for the Management of IBD into Clinical Practice | Baseline up to Month 24 | Percentage of physicians following the French national consensus for the management of IBD into clinical practice. |
| Number of Participants with Comorbodities, Previous Line of Therapy and Concomitant Treatments | 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 | — |
Countries
France
Outcome results
None listed