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

Last updated: January 3, 2025
Sponsor: Takeda
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Ulcerative Colitis

Inflammatory Bowel Disease

Bowel Dysfunction

Treatment

No Intervention

Clinical Study ID

NCT05192863
Vedolizumab-4038
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

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

Exclusion

Exclusion Criteria:

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

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

  3. Cognitive incapacity, unwillingness or language barriers precluding adequateunderstanding or cooperation.

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

  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 normalBWT of <=3 mm for all segments.

Study Design

Total Participants: 72
Treatment Group(s): 1
Primary Treatment: No Intervention
Phase:
Study Start date:
March 20, 2023
Estimated Completion Date:
October 31, 2025

Study 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.

Connect with a study center

  • University of Calgary

    Calgary, Alberta T2N 4N1
    Canada

    Site Not Available

  • University of Saskatchewan

    Saskatoon, Saskatchewan S7N 0W8
    Canada

    Site Not Available

  • University of McMaster

    Hamilton,
    Canada

    Site Not Available

  • Hadassah Medical Center

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Rabin Medical Center

    Petah Tikva, 4941492
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, 5262000
    Israel

    Site Not Available

  • Ospedale ASST Rhodense

    Rho, Milano 20017
    Italy

    Site Not Available

  • Rho Hospital

    Milan,
    Italy

    Site Not Available

  • ASST Fatebenefratelli Sacco

    Milano, 20157
    Italy

    Site Not Available

  • Fondazione Ca' Granda Ospedale Maggiore Policlinico

    Milano, 20122
    Italy

    Site Not Available

  • Ospedale San Raffaele

    Milano, 20132
    Italy

    Site Not Available

  • A.O.U. Federico II

    Napoli, 80131
    Italy

    Site Not Available

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