Characterization of CD Responders to Vedolizumab

Ulcerative Colitis Clinical Trial

Official title:

Immunophenotypic Characterization of Crohn's Disease (CD) Responders to Vedolizumab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04909359
• Other study ID #: 20150750
• Secondary ID: VEDO-IISR-2014-1
• Status: Completed
• Start date: August 25, 2015
• Est. completion date: May 18, 2020

Study information

• Verified date: May 2021
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 18, 2020
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria:

1. Male or Female =18 and =70 years old.

2. Patients must be appropriate for baseline colonoscopy prior to induction therapy with vedolizumab.

3. Patients must have active inflammatory disease as seen by colonoscopy. 3A-Adult patients with moderately to severely active UC who have:

1. had an inadequate response with, lost response to, or were;

2. intolerant to a tumor necrosis factor (TNF) blocker or;

3. immunomodulator; or had an inadequate response with, were;

4. 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

1. had an inadequate response with, lost response to, or were

2. intolerant to a TNF blocker or immunomodulator; or had an

3. inadequate response with, were intolerant to, or demonstrated

4. dependence on corticosteroids:

• achieving clinical response

• achieving clinical remission

• achieving corticosteroid-free remission

4. Patients will also have biochemical analysis with CRP and fecal calprotectin prior to initiating treatment with vedolizumab.

Exclusion criteria:

1. Patients that will not undergo colonoscopy at baseline prior to treatment with vedolizumab.

2. Patients who do not have endoscopic or biochemical (CRP, calprotectin) evidence of inflammation.

3. Patients that have been on natalizumab within 12 weeks of beginning vedolizumab.

4. Previous treatment with cyclosporine, thalidomide, or investigational drugs within 30 days of enrollment, prior treatment with vedolizumab

5. Toxic megacolon

6. Abdominal abscess

7. Symptomatic colonic stricture

8. Stoma

9. 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.

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Ulcerative Colitis

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T cell concentration	Evaluated from peripheral blood samples and lamina propria biopsies	up to 22 weeks
Secondary	Effector memory T cells concentration	Evaluated from peripheral blood samples and lamina propria biopsies	up to 22 weeks
Secondary	T regulatory cells concentration	Evaluated from peripheral blood samples and lamina propria biopsies	up to 22 weeks