An Open Label Single-arm Phase 4 Study of Vedolizumab in Subjects With Newly Diagnosed Active Ulcerative Colitis

NCT03237260 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 825665
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this research study is to determine whether starting the drug vedolizumab earlier than its FDA approved use can lead to better control of UC then using older drugs that we have historically used to treat UC. Vedolizumab is FDA-approved to be used after initial Corticosteroid treatments have failed or other UC treatments have failed. We will study if using vedolizumab as an early treatment for your UC will allow you to get off corticosteroids and prevent UC from worsening and requiring surgery. Vedolizumab is given intravenously initially every 2 weeks and then every 8 weeks.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• corticosteroid free remission as well as the absence of a colectomy

  corticosteroid free remission as well as the absence of a colectomy

  52 weeks

Study Arms (1)

Vedolizumab 300mg

EXPERIMENTAL

vedolizumab open label

Drug: Vedolizumab

Interventions

Vedolizumab DRUG

Initiation: 300 mg at week 0, 2 and 6. Maintenance: Every 8 weeks after the sixth week at a fixed dose of 300 mg

Also known as: entyvio

Vedolizumab 300mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed active ulcerative colitis, defined as a Mayo Clinic score of 6 to 12
• Prior Sigmoidoscopy sub score of at least 2, and disease that extended 15 cm or more from the anal verge
• Must have required CS for treatment of their symptoms within 2 weeks of diagnosis and have not reached symptom adequate response and they still have moderate to severe disease, indicated by a Mayo score 6 - 12
• In subjects that enroll and are eligible to continue in the study, study drug needs to be started within 3 months of the subject starting corticosteroids

You may not qualify if:

• Currently treated with either anti-TNF therapy, immunomodulators or methotrexate due to the severity of their condition, making them not appropriate for vedolizumab
• Toxic megacolon, abdominal abscess, symptomatic colonic stricture, an increased risk of infectious complications
• An anticipated requirement for major surgery, colonic dysplasia or adenomas and malignant neoplasms
• Neurological disorders
• Pregnant or lactating females
• Clinical response to steroids prior to starting study drug

Sponsors & Collaborators

• University of Pennsylvania: lead
• Takeda: collaborator
• Corporal Michael J. Crescenz VA Medical Center: collaborator

Study Sites (2)

Corporal Michael J. Crescenz VA Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

vedolizumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Nabeel Khan, MD

  Assistant Professor of Clinical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: August 2, 2017
• Study Start: July 1, 2017
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: July 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)