Back to resultsResearch Study in Patients With Severe Ulcerative Colitis
Primary Purpose
Ulcerative Colitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Visilizumab
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Colitis, Gastrointestinal Disease, Digestive System Disease, Intestinal Disease, Colonic Disease
Eligibility Criteria
A diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed within 36 months prior to study entry. Active disease despite ongoing treatment with steroids
Sites / Locations
- Cedars-Sinai Medical Center
- University of California
- Atlanta Gastroenterology Associates
- The University of Chicago Medical Center
- Mayo Clinic
- Mount Sinai School of Medicine
- University of Pittsburgh School of Medicine
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00032305
Brief Title
Research Study in Patients With Severe Ulcerative Colitis
Official Title
A Phase I, Dose-Escalation, Pilot Study of Visilizumab in Patients With Severe Ulcerative Colitis That is Refractory to Corticosteroids
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Facet Biotech
4. Oversight
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Colitis, Gastrointestinal Disease, Digestive System Disease, Intestinal Disease, Colonic Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Visilizumab
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
A diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed within 36 months prior to study entry.
Active disease despite ongoing treatment with steroids
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
Country
United States
Facility Name
University of California
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
The University of Chicago Medical Center
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
Country
United States
Facility Name
University of Pittsburgh School of Medicine
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17920064
Citation
Plevy S, Salzberg B, Van Assche G, Regueiro M, Hommes D, Sandborn W, Hanauer S, Targan S, Mayer L, Mahadevan U, Frankel M, Lowder J. A phase I study of visilizumab, a humanized anti-CD3 monoclonal antibody, in severe steroid-refractory ulcerative colitis. Gastroenterology. 2007 Nov;133(5):1414-22. doi: 10.1053/j.gastro.2007.08.035. Epub 2007 Aug 21.
Results Reference
derived
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Research Study in Patients With Severe Ulcerative Colitis
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