Research Study in Patients With Severe Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

A Phase I, Dose-Escalation, Pilot Study of Visilizumab in Patients With Severe Ulcerative Colitis That is Refractory to Corticosteroids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00032305
• Other study ID #: 291-406
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 14, 2002
• Last updated: March 6, 2012
• Start date: March 2002
• Est. completion date: November 2005

Study information

• Verified date: March 2012
• Source: Facet Biotech
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat severe ulcerative colitis refractory to steroid therapy. The research is being conducted at up to 8 clinical research sites in the US and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site. All study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work.

Description:

A Phase I, dose-escalation, pilot study designed to obtain safety and tolerability data on visilizumab administered to patients with severe ulcerative colitis that has failed to respond to steroid therapy. Patients who are currently receiving IV corticosteroids, but whose disease has not responded after at least 5 days of this therapy, will be eligible for the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

1. A diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed within 36 months prior to study entry.

2. Active disease despite ongoing treatment with steroids

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Visilizumab

Locations

Country	Name	City	State
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	The University of Chicago Medical Center	Chicago	Illinois
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Mount Sinai School of Medicine	New York	New York
United States	University of Pittsburgh School of Medicine	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Facet Biotech

Country where clinical trial is conducted

United States,