Clinical trial NCT00102193: Study for the Treatment of Ulcerative Colitis With Adacolumn
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis, Apheresis
Lead sponsor: Otsuka America Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2005-01-25
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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)

Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness will be primarily evaluated at Week 12 by disease activity index (DAI) score
measure: Safety will be evaluated by determining the frequency and severity of adverse events
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Scottsdale
state: Arizona
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Wheat Ridge
country: United States
facility: Rocky Mountain Gastroenterology Associates, PC
state: Colorado
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Chicago
country: United States
facility: University of Chicago, Department of Medicine, Section of Gastroenterology
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Chevy Chase
country: United States
facility: Metropolitan Gastroenterology Group
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital, GI Unit
state: Massachusetts
city: Boston
country: United States
facility: Tufts University School of Medicine, Caritas St. Elizabeth's Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Clinton Township
country: United States
facility: Clinical Research Institute of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina, Division of Digestive Disease & Nutrition
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Oklahoma City
country: United States
facility: Digestive Disease Specialists Inc.
state: Oklahoma
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southern Medical Center
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
city: Edmonton
country: Canada
facility: Walter Mackenzie Health Sciences Centre
state: Alberta
city: Abbotsford
country: Canada
facility: Gastroenterology and Hepatology Clinic
state: British Columbia
city: Vancouver
country: Canada
facility: St Paul's Hospital, University of British Columbia
state: British Columbia
city: Kingston
country: Canada
facility: Hotel-Dieu Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre, South Street Campus
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre, University Campus
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital-Civic Campus
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Lévis
country: Canada
facility: Hôtel-Dieu de Lévis
state: Quebec
city: Montreal
country: Canada
facility: Sir Mortimer B. Davis Jewish General Hospital
state: Quebec
Study officials:
affiliation: Otsuka America Pharmaceutical
name: Yosuke Komatsu, MD, PhD
role: STUDY_DIRECTOR
References: