Study for the Treatment of Ulcerative Colitis With Adacolumn

Ulcerative Colitis Clinical Trial

Official title:

A Randomized, Prospective, Double-Blinded, Placebo-Controlled (Sham-Controlled) Study to Evaluate the Safety and Effectiveness of the Adacolumn Apheresis System for the Treatment of Moderate to Severe Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00102193
• Other study ID #: 512-04-205
• Status: Completed
• Phase: Phase 3
• First received: January 24, 2005
• Last updated: September 5, 2008
• Start date: July 2004
• Est. completion date: July 2006

Study information

• Verified date: April 2008
• Source: Otsuka America Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate the safety and effectiveness of the Adacolumn Apheresis System to treat the signs and symptoms of ulcerative colitis.

Description:

Trial Features:

• Non-drug therapy

• Most patients can remain on current treatment regimen, including prednisone, budesonide and medications such as Asacol (mesalamine), Pentasa (mesalamine), Colazal (balsalazide disodium) and Dipentum (olsalazine sodium) throughout the study

Components of the Study:

• Study length is 24 weeks, which includes a screening visit, ten treatment visits over nine weeks and 4 follow-up appointments

• Physical exams, laboratory tests and disease assessments conducted at no charge to the patient

• 2:1 Randomization (treatment:sham)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Key Inclusion Criteria:

• Moderate to severe active ulcerative colitis with colonic involvement with ulcerative colitis beyond 15 cm of the anal verge

• Adequate peripheral venous access to allow for completion of the apheresis treatments

• Receiving one or more of the following medical therapies:

*sulfasalazine, *mesalamine and other 5-ASA agents, *prednisone or 6-mercaptopurine or azathioprine OR Have not received the above medical therapies due to intolerance or demonstrated non-response

• Agree to participate in the required follow-up visits

• Able to complete a diary

• Signed written informed consent document and authorization for use of protected health information

Key Exclusion Criteria:

• Evidence of toxic megacolon

• Major surgery within the past 6 weeks or anticipated need for surgery within 12 weeks

• Proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis

• Requiring in-patient hospitalization

• A history of allergic reaction to heparin or heparin-induced thrombocytopenia

• A history of hypersensitivity reaction associated with an apheresis procedure or intolerance of apheresis procedures

• A history of severe cardiovascular or peripheral arterial diseases

• A history of cerebral vascular diseases

• Liver diseases

• Renal insufficiency

• Insulin-dependent Type I or Type II diabetes

• Known bleeding disorder or use of concomitant anticoagulant therapy for purposes other than apheresis treatment

• Any hypercoagulable disorder

• Known infection with Hepatitis B or C, or HIV

• Severe anemia

• Leukopenia or granulocytopenia

• Evidence of current systemic infection

• Malignancy

• Pregnant, lactating or planning to become pregnant during the course of the investigational study

• Used within the last 30 days, an investigational drug, biologic or device or 5 half-lives, if known, for any investigational drug or biologic

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Device:
• Adacolumn Apheresis System

Locations

Country	Name	City	State
Canada	Gastroenterology and Hepatology Clinic	Abbotsford	British Columbia
Canada	Walter Mackenzie Health Sciences Centre	Edmonton	Alberta
Canada	Hotel-Dieu Hospital	Kingston	Ontario
Canada	Hôtel-Dieu de Lévis	Lévis	Quebec
Canada	London Health Sciences Centre, South Street Campus	London	Ontario
Canada	London Health Sciences Centre, University Campus	London	Ontario
Canada	Sir Mortimer B. Davis Jewish General Hospital	Montreal	Quebec
Canada	The Ottawa Hospital-Civic Campus	Ottawa	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	St Paul's Hospital, University of British Columbia	Vancouver	British Columbia
United States	University of Michigan	Ann Arbor	Michigan
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Massachusetts General Hospital, GI Unit	Boston	Massachusetts
United States	Tufts University School of Medicine, Caritas St. Elizabeth's Medical Center	Boston	Massachusetts
United States	Providence Clinical Research	Burbank	California
United States	University of North Carolina, Division of Digestive Disease & Nutrition	Chapel Hill	North Carolina
United States	Metropolitan Gastroenterology Group	Chevy Chase	Maryland
United States	University of Chicago, Department of Medicine, Section of Gastroenterology	Chicago	Illinois
United States	Consultants for Clinical Research	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Clinical Research Institute of Michigan	Clinton Township	Michigan
United States	University of Texas Southern Medical Center	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Texas Medical Branch	Galveston	Texas
United States	Long Island Clinical Research Associates	Great Neck	New York
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Kentucky Medical Center	Lexington	Kentucky
United States	University of Wisconsin-Madison	Madison	Wisconsin
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Digestive Disease Specialists Inc.	Oklahoma City	Oklahoma
United States	Mayo Clinic Scottsdale	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California, San Francisco	San Francisco	California
United States	University of Washington Medical Center	Seattle	Washington
United States	Rocky Mountain Gastroenterology Associates, PC	Wheat Ridge	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka America Pharmaceutical

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness will be primarily evaluated at Week 12 by disease activity index (DAI) score
Primary	Safety will be evaluated by determining the frequency and severity of adverse events

External Links

•   Manufacturer's site in Japan