RECRUITING

VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study

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Conditions

Crohn's DiseaseVedolizumabUstekinumabPatient reported outcomeIL-23 antagonistsRisankizumab

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary aim of this study is to explore the time course of response to Vedolizumab in participants with CD as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-short form (SF), as well as other PROMIS domain SFs (fatigue, anxiety, depression, sleep disturbance, physical function, and ability to participate in social roles and activities); other PRO measures will also be assessed.

Official Title

VOICE-Characterization of Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease Using Patient-Reported Outcome Measures: A Prospective Observational Study

Quick Facts

Study Start:2024-03-20
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06249555

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participant is an adult 18 years of age or older with confirmed CD, as per standard clinical criteria which may include symptoms, endoscopy, histopathology, and imaging.
  2. 2. Participant has active CD and has been prescribed as standard of care (SOC) and is planned to start VDZ or IL-23 antagonist therapy (UST, RISA, or GUS or MIR \[if approved for the treatment of CD during the recruitment period for this study\]) for the first time in accordance with the product label, as determined by the treating physician.
  3. 3. Participant has a baseline PROMIS Pain Interference-SF score ≥ 15 (corresponding T-score ≥ 55) (PROMIS Pain Interference-SF 8a \[V1.1\]).
  4. 4. Participant has completed all SOC biologic work-up assessments (this may include assessment of tuberculosis, chronic infections, Clostridioides difficile infection and vaccination status per local practice).
  5. 5. Ability of participant to participate fully in all aspects of this observational study. Full comprehension of consent language and informed consent must be obtained from the participant and documented.
  1. 1. Participant has CD-related surgery planned or anticipated during the study.
  2. 2. Participant has prior exposure to an advanced therapy for the treatment of CD (biologic or small molecule) other than an anti-TNF (i.e., anti-integrin, anti-IL, Janus kinase inhibitors, or sphingosine-1-phosphate receptor 1). Prior failure or intolerance to 2 or more anti-TNF (i.e., infliximab, adalimumab, or certolizumab pegol) therapies in the past 3 years is also cause for exclusion.
  3. 3. Participant has an active infection at baseline requiring intravenous systemic antibiotics.
  4. 4. Participant has evidence of C. difficile toxin or is prescribed treatment for C. difficile infection, or other intestinal bacterial pathogen, ≤ 2 weeks prior to Screening.
  5. 5. Participant has chronic non-inflammatory bowel disease pain.

Contacts and Locations

Study Contact

Susan Archer
CONTACT
226-919-6959
susan.archer@alimentiv.com
Heather MacAulay
CONTACT
heather.macaulay@alimentiv.com

Study Locations (Sites)

Digestive and Liver Center of Florida
Kissimmee, Florida, 34741
United States
Northwestern University
Evanston, Illinois, 60611
United States
University of Iowa
Iowa City, Iowa, 52242
United States
University of North Carolina
Chapel Hill, North Carolina, 27599
United States
OR Clinic - East - GI
Portland, Oregon, 97220
United States

Collaborators and Investigators

Sponsor: Alimentiv Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-20
Study Completion Date2026-09

Study Record Updates

Study Start Date2024-03-20
Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

  • Vedolizumab
  • Ustekinumab
  • Patient reported outcome
  • IL-23 antagonists
  • Risankizumab

Additional Relevant MeSH Terms

  • Crohn's Disease