A Study of Vedolizumab in Adults With Crohn’s Disease (CD)

Overview

The main aim of this study is to see if adults with CD treated with vedolizumab have less symptoms and inflammation of the bowel assessed by ultrasonography. Participants will be treated with vedolizumab according to their clinic's standard practice.

Full Title of Study: “Complete Remission in Patients With Moderately to Severely Active Crohn’s Disease Treated With Vedolizumab – A Multicenter, Prospective Observational Cohort Study in Canada, Italy, and Israel”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 30, 2024

Detailed Description

This is a non-interventional, prospective study of participants with moderately to severely active CD who are initiating or currently ongoing induction treatment with vedolizumab according to the current summary of product characteristics (SmPC) in the real world setting. The study will enroll approximately 100 participants. The data will be collected prospectively at the study sites and will be recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort: Participants with CD This multi-center study will be conducted in Canada, Italy, and Israel at specialized gastroenterology centers. The overall duration of the study will be 18 months. Data will be collected at baseline, at 10 weeks (± 4 weeks) after induction, and every 6 months (± 4 weeks) after that, and at the time of changes in treatment, study discontinuation and/or at routine follow-up visits.

Interventions

  • Other: No Intervention
    • This is a non-interventional study.

Arms, Groups and Cohorts

  • Participants with CD
    • Participants diagnosed with moderately to severely active CD who are initiating vedolizumab intravenous (IV) induction treatment with the option to switch to vedolizumab subcutaneous (SC) treatment, as maintenance therapy in accordance with the current SmPC will be observed prospectively for 18 months.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants Who Achieve Complete Remission 12 Months After Initiation of Vedolizumab Therapy
    • Time Frame: Baseline up to 12 months
    • Complete remission will be measured by corticosteroid-free clinical, biochemical and transmural remission. Corticosteroid-free defined as no usage of any systemic or locally acting steroid. Corticosteroid-free clinical remission defined as Harvey Bradshaw Index (HBI) less than (<) 5 points and no concomitant corticosteroids. HBI score measures disease activity of CD. Clinical parameters: general well-being (0-4, higher score lower well being), abdominal pain (0-3, higher score more severe pain), number of liquid stools/day, abdominal mass (0-3, higher score presence of swelling in abdomen), complications (score 1/item). Total is sum of individual parameters. Score: minimum 0 – no pre-specified maximum score, depends on number of liquid stools, higher scores indicating more severe disease. Biochemical remission defined as C-reactive protein (CRP) and fecal calprotectin (FCal) normalization. Transmural remission defined as BWT of <3 millimeter (mm) for all bowel segments.

Secondary Measures

  • Percentage of Participants Who Achieve Complete Remission
    • Time Frame: Up to Month 18
    • Complete remission will be measured by corticosteroid-free clinical, biochemical and transmural remission. Corticosteroid-free defined as no usage of any systemic or locally acting steroid. Corticosteroid-free clinical remission defined as HBI <5 points and no concomitant corticosteroids. HBI score used to measure disease activity of CD. Clinical parameters: general well-being (0-4, higher score lower well being), abdominal pain (0-3, higher score more severe pain), number of liquid stools/day, abdominal mass (0-3, higher score presence of swelling in abdomen), and complications (score 1 per item). Total is sum of individual parameters. Score: minimum score of 0 – no pre-specified maximum score, depends on number of liquid stools, higher scores indicating more severe disease. Biochemical remission defined as CRP and FCal normalization. Transmural remission defined as BWT of <3 mm for all bowel segments.
  • Percentage of Participants Who Achieve Corticosteroid-free Clinical Remission
    • Time Frame: Up to Month 18
    • Corticosteroid-free defined as no usage of any systemic or locally acting steroid. Corticosteroid-free clinical remission defined as HBI <5 points and no concomitant corticosteroids. HBI score used to measure disease activity of CD. Clinical parameters: general well-being (0-4, higher score lower well being), abdominal pain (0-3, higher score more severe pain), number of liquid stools/day, abdominal mass (0-3, higher score presence of swelling in abdomen), and complications (score 1 per item). Total is sum of individual parameters. Score: minimum score of 0 – no pre-specified maximum score, depends on number of liquid stools, higher scores indicating more severe disease.
  • Percentage of Participants Who Achieve Biochemical Remission
    • Time Frame: Up to Month 18
    • Biochemical remission defined as CRP and FCal normalization.
  • Percentage of Participants Who Achieve Transmural Remission
    • Time Frame: Up to Month 18
    • Transmural remission defined as BWT of <3 mm for all bowel segments.
  • Percentage of Participants Who Achieve Clinical Response
    • Time Frame: Up to Month 18
    • Clinical response is defined as a reduction of greater than or equal to (>=) 3 points from the baseline HBI score. HBI score is used to measure the disease activity of CD. It consists of clinical parameters: general well-being (0-4, where higher score means lower well being), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools, where higher scores indicating more severe disease.
  • Percentage of Participants Who Achieve Transmural Response
    • Time Frame: Up to Month 18
    • Transmural response is defined as a minimum reduction of 25 percent (%) of BWT from baseline or absolute BWT <=3 mm.
  • Percentage of Participants With Vedolizumab Treatment Optimization
    • Time Frame: Up to Month 18
  • Percentage of Participants With Acceptance of Intestinal Ultrasonography (IUS) Monitoring and Assessment
    • Time Frame: Up to Month 18
    • IUS is a 6 item questionnaire visual analogue scale (VAS). Out of 6 items, 2 items has score range 1 (completely unacceptable) to 10 (completely acceptable): Item 1-Acceptability as monitoring tool in IBD; and Item 2-Acceptability of other monitoring tools in IBD including 6 sub items with score range 1 to 10. Item 3- IUS examination leading to improvement of knowledge of their illness with score range 1 (totally useless) to 10 (very useful). Item 4: Tolerability of IUS with score range 1 (no discomfort) to 10 (much discomfort). Item 5: Choice of monitoring modality with score range 1 (most preferred) to 5 (least preferred). Item 6: IUS examination leading to improvement of knowledge/understanding of illness including 5 sub-items with score range of 1 (completely disagree) to 10 (strongly agree). Responses to these 6 questions will be summed to maximum score of 145. The total score range represents participant’s experience of IUS and their acceptability to this assessment.
  • Percentage of Participants With Improved Quality of Life Based on Health-related Quality of Life (HRQoL) as Measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
    • Time Frame: Baseline up to Month 18
    • The SIBDQ is an instrument used to assess quality of life and is a disease-specific HRQoL questionnaire, that consists of 10 questions grouped into four different dimensions: social, bowel, emotional, and systemic, each question is scored on a scale from 1 (a severe problem) to 7 (not a problem at all). The total score will be reported and will range from 10 to 70 with a higher score indicates a better health-related QoL.
  • Percentage of Participants With CD-related hospitalizations, CD-related emergency room (ER) visits, CD-related surgeries, CD-related flares requiring IV corticosteroid or related complications Health Care Resources Utilization (HCRU)
    • Time Frame: Up to Month 18
    • HCRU will be calculated for CD-related hospitalizations, CD-related ER visits, CD-related surgeries, CD-related flares requiring IV corticosteroid or related complications as available in the medical record and captured in the electronic case report form (eCRF).
  • Percentage of Participants With Treatment Discontinuation
    • Time Frame: Up to Month 18
  • Percentage of Participants With Change in Vedolizumab Dosing Frequency
    • Time Frame: Up to Month 18
  • Percentage of Participants Who Changed to Another Therapy
    • Time Frame: Up to Month 18
  • Percentage of Participants With Concomitant Therapies for CD
    • Time Frame: Up to Month 18
    • Concomitant therapies for CD including introduction and discontinuation of systemic steroids; any changes and reasons for changing including dosing regimen changes, discontinuation, initiation etc.
  • Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)
    • Time Frame: Up to Month 18
  • Number of Participants Reporting one or More Serious Adverse Events (SAEs)
    • Time Frame: Up to Month 18
  • Number of Participants Reporting one or More Adverse Events of Special Interest (AESIs)
    • Time Frame: Up to Month 18

Participating in This Clinical Trial

Inclusion Criteria

1. Has moderately to severely active CD with a bowel wall thickness (BWT) of >3 mm, based on IUS. 2. Newly initiating IV vedolizumab induction treatment in accordance with the current SmPC (switch to SC is acceptable at maintenance treatment stage). Exclusion Criteria:

1. Contraindications to vedolizumab therapy as defined in the current SmPC:

  • Prior history of intolerability, hypersensitivity to the active substance or to any of the excipients of vedolizumab – Active severe infections such as tuberculosis (TB), sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML) 2. Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. 3. Current or planned participation in an interventional clinical trial for CD within the past 30 days. 4. Active perforating complications (fistulizing CD), current strictures (definition >50% reduction of bowel lumen and pre-stenotic dilatation) as well as historic strictures (based on medical chart). 5. Characteristics precluding IUS visualization of affected bowel segments or normal BWT of <=3 mm for all segments.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Takeda
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Study Director, Study Director, Takeda
  • Overall Contact(s)
    • Takeda Contact, +1-877-825-3327, medinfoUS@takeda.com

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