Clinical trial NCT05192863: A Study of Vedolizumab in Adults With Crohn's Disease (CD)
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Crohn's Disease
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2022-01-14
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with moderately to severely active CD initiating vedolizumab therapy in a routine clinical care, with a BWT of \>3 mm, based on IUS assessment.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Who Achieve Complete Remission 12 Months After Initiation of Vedolizumab Therapy
timeFrame: Baseline up to 12 months
Secondary outcomes:
measure: Percentage of Participants Who Achieve Complete Remission
timeFrame: Up to Month 18
measure: Percentage of Participants Who Achieve Corticosteroid-free Clinical Remission
timeFrame: Up to Month 18
measure: Percentage of Participants Who Achieve Biochemical Remission
timeFrame: Up to Month 18
measure: Percentage of Participants Who Achieve Transmural Remission
timeFrame: Up to Month 18
measure: Percentage of Participants Who Achieve Clinical Response
timeFrame: Up to Month 18
measure: Percentage of Participants Who Achieve Transmural Response
timeFrame: Up to Month 18
measure: Percentage of Participants With Change, and Reason for Change in Vedolizumab Dosing Frequency
timeFrame: Up to Month 18
measure: Percentage of Participants Who Switched to Vedolizumab SC Formulation
timeFrame: Up to Month 18
measure: Percentage of Participants Who Discontinued Vedolizumab Treatment and Reason for Discontinuation
timeFrame: Up to Month 18
measure: Percentage of Participants With Prior Treatments for CD, and Reason for Discontinuation
timeFrame: Up to Month 18
measure: Percentage of Participants With Concomitant Therapies for CD
timeFrame: Up to Month 18
measure: Percentage of Participants Who Switched to Other CD Therapy After Vedolizumab Discontinuation
timeFrame: Up to Month 18
measure: Percentage of Participants With Acceptance of IUS Monitoring and Assessment
timeFrame: Up to Month 18
measure: 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)
timeFrame: Baseline up to Month 18
measure: 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
timeFrame: Up to Month 18
measure: Number of Participants Reporting one or More Adverse Drug Reactions (ADRs)
timeFrame: Up to Month 18
measure: Number of Participants Reporting one or More Serious Adverse Events (SAEs)
timeFrame: Up to Month 18
measure: Number of Participants Reporting one or More Adverse Events of Special Interest (AESIs)
timeFrame: Up to Month 18
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Rho
country: Italy
facility: Ospedale ASST Rhodense
state: Milano
city: Milano
country: Italy
facility: Fondazione Ca' Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Milano
country: Italy
facility: ASST Fatebenefratelli Sacco
city: Napoli
country: Italy
facility: A.O.U. Federico II
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: