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

Crohn's Disease Clinical Trial

— SUNRISE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05192863
• Other study ID #: Vedolizumab-4038
• Status: Recruiting
• Start date: March 20, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: June 2023
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

This is a non-interventional, prospective study of participants with moderately to severely active CD who are initiating 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Has moderately to severely active CD with a BWT of >3 mm, based on IUS performed within the previous 4 weeks from baseline.

2. Newly initiating IV vedolizumab induction treatment in accordance with the current SmPC either at enrolment or within 2 weeks after enrolment (switch to SC is acceptable at maintenance treatment stage).

Exclusion Criteria:

1. Prior history of intolerability, hypersensitivity to the active substance or to any of the excipients of vedolizumab.

2. Active severe infections such as tuberculosis (TB), sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML).

3. Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

4. Current or previous participation in an interventional clinical trial for CD within the past 30 days, or planned to be enrolled in an interventional clinical trial for CD.

5. Ongoing or planned pregnancy or breastfeeding participants.

6. Active perforating complications or significant current strictures (assessed by IUS, with or without pre-stenotic dilatation) as per clinical judgement.

7. Characteristics precluding IUS visualization of affected bowel segments or normal BWT of <=3 mm for all segments.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

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

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	University of Saskatchewan	Saskatoon	Saskatchewan
Israel	Hadassah Medical Center	Jerusalem
Israel	Rabin Medical Center	Petah Tikva
Israel	Sheba Medical Center	Ramat Gan
Italy	ASST Fatebenefratelli Sacco	Milano
Italy	Fondazione Ca' Granda Ospedale Maggiore Policlinico	Milano
Italy	Ospedale San Raffaele	Milano
Italy	A.O.U. Federico II	Napoli
Italy	Ospedale ASST Rhodense	Rho	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

Canada,  Israel,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Achieve Complete Remission 12 Months After Initiation of Vedolizumab Therapy	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 bowel wall thickness(BWT) of <3 millimeter (mm) for all bowel segments upon IUS.	Baseline up to 12 months
Secondary	Percentage of Participants Who Achieve Complete Remission	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 is used to measure disease activity of CD. Biochemical remission defined as CRP and FCal normalization. Transmural remission defined as BWT of <3 mm for all bowel segments upon Intestinal Ultrasonography (IUS).	Up to Month 18
Secondary	Percentage of Participants Who Achieve Corticosteroid-free Clinical 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 is used to measure disease activity of CD.	Up to Month 18
Secondary	Percentage of Participants Who Achieve Biochemical Remission	Biochemical remission defined as CRP and FCal normalization.	Up to Month 18
Secondary	Percentage of Participants Who Achieve Transmural Remission	Transmural remission defined as BWT of <3 mm for all bowel segments upon IUS.	Up to Month 18
Secondary	Percentage of Participants Who Achieve Clinical Response	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.	Up to Month 18
Secondary	Percentage of Participants Who Achieve Transmural Response	Transmural response is defined as a minimum reduction of 25 percent (%) of BWT from baseline or absolute BWT less than or equal to (<=) 3 mm upon IUS.	Up to Month 18
Secondary	Percentage of Participants With Change, and Reason for Change in Vedolizumab Dosing Frequency		Up to Month 18
Secondary	Percentage of Participants Who Switched to Vedolizumab SC Formulation		Up to Month 18
Secondary	Percentage of Participants Who Discontinued Vedolizumab Treatment and Reason for Discontinuation		Up to Month 18
Secondary	Percentage of Participants With Prior Treatments for CD, and Reason for Discontinuation		Up to Month 18
Secondary	Percentage of Participants With Concomitant Therapies for CD	Concomitant therapies for CD including introduction and discontinuation of systemic steroids; any changes and reasons for changing including dosing regimen changes, discontinuation, initiation etc.	Up to Month 18
Secondary	Percentage of Participants Who Switched to Other CD Therapy After Vedolizumab Discontinuation		Up to Month 18
Secondary	Percentage of Participants With Acceptance of IUS Monitoring and Assessment	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.	Up to Month 18
Secondary	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)	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.	Baseline up to Month 18
Secondary	Percentage of Participants With CD-related hospitalizations, CD-related emergency room (ER) visits, CD-related surgeries, CD-related flares requiring IV Induction Therapy or IV Corticosteroid Therapy	Health Care Resources Utilization (HCRU) will be calculated as available in the medical record and captured in the eCRF.	Up to Month 18
Secondary	Number of Participants Reporting one or More Adverse Drug Reactions (ADRs)		Up to Month 18
Secondary	Number of Participants Reporting one or More Serious Adverse Events (SAEs)		Up to Month 18
Secondary	Number of Participants Reporting one or More Adverse Events of Special Interest (AESIs)		Up to Month 18

External Links

•   To obtain more information on the study, click on this link.