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Study for the Treatment of Ulcerative Colitis With Adacolumn

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Adacolumn Apheresis System
Sponsored by
Otsuka America Pharmaceutical
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, Apheresis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic Scottsdale
  • Providence Clinical Research
  • University of California, San Francisco
  • Rocky Mountain Gastroenterology Associates, PC
  • Atlanta Gastroenterology Associates
  • University of Chicago, Department of Medicine, Section of Gastroenterology
  • University of Kentucky Medical Center
  • Johns Hopkins Hospital
  • Metropolitan Gastroenterology Group
  • Massachusetts General Hospital, GI Unit
  • Tufts University School of Medicine, Caritas St. Elizabeth's Medical Center
  • University of Michigan
  • Clinical Research Institute of Michigan
  • Mayo Clinic
  • Dartmouth-Hitchcock Medical Center
  • Long Island Clinical Research Associates
  • University of North Carolina, Division of Digestive Disease & Nutrition
  • Duke University Medical Center
  • Consultants for Clinical Research
  • Cleveland Clinic Foundation
  • Digestive Disease Specialists Inc.
  • Vanderbilt University Medical Center
  • University of Texas Southern Medical Center
  • University of Texas Medical Branch
  • University of Washington Medical Center
  • University of Wisconsin-Madison
  • Walter Mackenzie Health Sciences Centre
  • Gastroenterology and Hepatology Clinic
  • St Paul's Hospital, University of British Columbia
  • Hotel-Dieu Hospital
  • London Health Sciences Centre, South Street Campus
  • London Health Sciences Centre, University Campus
  • The Ottawa Hospital-Civic Campus
  • St. Michael's Hospital
  • Mount Sinai Hospital
  • Hôtel-Dieu de Lévis
  • Sir Mortimer B. Davis Jewish General Hospital

Outcomes

Primary Outcome Measures

Effectiveness will be primarily evaluated at Week 12 by disease activity index (DAI) score
Safety will be evaluated by determining the frequency and severity of adverse events

Secondary Outcome Measures

Full Information

First Posted
January 24, 2005
Last Updated
September 5, 2008
Sponsor
Otsuka America Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT00102193
Brief Title
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

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Otsuka America Pharmaceutical

4. Oversight

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative Colitis, Apheresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
168 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Adacolumn Apheresis System
Primary Outcome Measure Information:
Title
Effectiveness will be primarily evaluated at Week 12 by disease activity index (DAI) score
Title
Safety will be evaluated by determining the frequency and severity of adverse events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yosuke Komatsu, MD, PhD
Organizational Affiliation
Otsuka America Pharmaceutical
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Scottsdale
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Providence Clinical Research
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-1623
Country
United States
Facility Name
Rocky Mountain Gastroenterology Associates, PC
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
University of Chicago, Department of Medicine, Section of Gastroenterology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1436
Country
United States
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Metropolitan Gastroenterology Group
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Massachusetts General Hospital, GI Unit
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Tufts University School of Medicine, Caritas St. Elizabeth's Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Clinical Research Institute of Michigan
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Long Island Clinical Research Associates
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
University of North Carolina, Division of Digestive Disease & Nutrition
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7080
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Consultants for Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Digestive Disease Specialists Inc.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2285
Country
United States
Facility Name
University of Texas Southern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9016
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0632
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-5124
Country
United States
Facility Name
Walter Mackenzie Health Sciences Centre
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
Facility Name
Gastroenterology and Hepatology Clinic
City
Abbotsford
State/Province
British Columbia
ZIP/Postal Code
V2S 3N5
Country
Canada
Facility Name
St Paul's Hospital, University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Hotel-Dieu Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada
Facility Name
London Health Sciences Centre, South Street Campus
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
London Health Sciences Centre, University Campus
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
The Ottawa Hospital-Civic Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Hôtel-Dieu de Lévis
City
Lévis
State/Province
Quebec
ZIP/Postal Code
G6V 3W6
Country
Canada
Facility Name
Sir Mortimer B. Davis Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada

12. IPD Sharing Statement

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Study for the Treatment of Ulcerative Colitis With Adacolumn

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