Status:
COMPLETED
Characterization of CD Responders to Vedolizumab
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Takeda
Conditions:
Crohn Disease
Ulcerative Colitis
Eligibility:
All Genders
18-70 years
Brief Summary
The purpose of this study is to characterize which patients with Crohn's disease are likely to respond to standard of care to vedolizumab therapy.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male or Female ≥18 and ≤70 years old.
- Patients must be appropriate for baseline colonoscopy prior to induction therapy with vedolizumab.
- Patients must have active inflammatory disease as seen by colonoscopy. 3A-Adult patients with moderately to severely active UC who have:
- had an inadequate response with, lost response to, or were;
- intolerant to a tumor necrosis factor (TNF) blocker or;
- immunomodulator; or had an inadequate response with, were;
- intolerant to, or demonstrated dependence on corticosteroids:
- inducing and maintaining clinical response
- inducing and maintaining clinical remission
- improving endoscopic appearance of the mucosa
- achieving corticosteroid-free remission 3B-Adult patients with moderately to severely active CD who have
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- had an inadequate response with, lost response to, or were
- intolerant to a TNF blocker or immunomodulator; or had an
- inadequate response with, were intolerant to, or demonstrated
- dependence on corticosteroids:
- achieving clinical response
- achieving clinical remission
- achieving corticosteroid-free remission
- Patients will also have biochemical analysis with CRP and fecal calprotectin prior to initiating treatment with vedolizumab.
- Exclusion criteria:
- Patients that will not undergo colonoscopy at baseline prior to treatment with vedolizumab.
- Patients who do not have endoscopic or biochemical (CRP, calprotectin) evidence of inflammation.
- Patients that have been on natalizumab within 12 weeks of beginning vedolizumab.
- Previous treatment with cyclosporine, thalidomide, or investigational drugs within 30 days of enrollment, prior treatment with vedolizumab
- Toxic megacolon
- Abdominal abscess
- Symptomatic colonic stricture
- Stoma
- Increased risk of infection (eg, active or latent tuberculosis, immunodeficiency) Other clinically meaningful laboratory abnormalities: pregnancy or lactation, an unstable or uncontrolled medical disorder, colonic dysplasia or adenomas, and malignant neoplasms.
Exclusion
Key Trial Info
Start Date :
August 25 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 18 2020
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04909359
Start Date
August 25 2015
End Date
May 18 2020
Last Update
June 1 2021
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136