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

Terminated

• Conditions: Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases

• Registration Number: NCT03378388
• Lead Sponsor: Takeda

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.

Study Timeline

• Study First Submitted: 2017-12-11
• Study First Submitted QC: 2017-12-15
• Study First Posted: 2017-12-19
• Study Start: 2018-02-13
• Primary Completion: 2019-02-15
• Study Completion: 2019-02-15
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-12
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

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.

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Exclusion Criteria

1. 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).
2. Participation in an interventional study (but not in another non-interventional study).
3. Unclassified colitis.
4. Stomy.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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.
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	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 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 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	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 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 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.
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 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.
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

Trial Locations

Locations (13)

Centre Hospitalier Cote Basque; 🇫🇷 BAYONNE Cedex, France

Ch de Blois; 🇫🇷 Blois Cedex, France

Clinique du palais; 🇫🇷 Grasse, France

Ghef Ch Marne La Vallee; 🇫🇷 Jossigny, France

Hopital Edouard Herriot; 🇫🇷 Lyon Cedex 03, France

Ctre Hosp St Joseph Et St Luc; 🇫🇷 Lyon Cedex 07, France

Hopital Saint Eloi-Chru Montpellier; 🇫🇷 Montpellier Cedex 5, France

Ch Lyon Sud; 🇫🇷 Pierre Benite Cedex, France

Polyclinique Cote Basque Sud; 🇫🇷 St Jean de Luz Cedex, France

HOPITAL NORD-CHU de SAINT-ETIENNE; 🇫🇷 St Priest En Jarez Cedex, France

HOPITAUX DE BRABOIS-CHRU de NANCY; 🇫🇷 Vandoeuvre Les Nancy Cedex, France

Clinique Ambroise Pare; 🇫🇷 Toulouse, France

Gh mutualiste les portes du sud; 🇫🇷 Venissieux Cedex, France