Characterization of CD Responders to Vedolizumab

NCT ID: NCT04909359

Last Updated: 2021-06-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 51 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-25
• Study Completion Date: 2020-05-18

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.

Conditions

Crohn Disease; Ulcerative Colitis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Crohn's disease (CD)

People with CD recently receiving vedolizumab as standard of care will be followed up to 5 years.

No interventions assigned to this group

Ulcerative colitis (UC)

People with UC recently receiving vedolizumab as standard of care will be followed up to 5 years.

No interventions assigned to this group

Eligibility Criteria

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

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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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Maria Abreu

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria T Abreu, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

VEDO-IISR-2014-100892

Identifier Type: OTHER

Identifier Source: secondary_id

20150750

Identifier Type: -

Identifier Source: org_study_id