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Study for the Treatment of Crohn's Disease With Adacolumn

Primary Purpose

Crohn's Disease

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

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease

Eligibility Criteria

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

Key Inclusion Criteria: Moderate to severe Crohn's disease Adequate peripheral venous access 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: Extremely severe Crohn's disease Known obstructive symptoms within the past 3 months Presence of toxic megacolon Major surgery within the past 6 weeks or anticipated need for surgery within 12 weeks Total colectomy, ileostomy, stoma or 100 cm of resected small bowel 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 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
  • Capitol Gastroenterology Consultants Medical Group
  • UCSF Mount Zion Medical Center
  • Rocky Mountain Gastroenterology Associates, PC
  • Medical Research Institute of Connecticut
  • Venture Research Institute, LLC
  • Atlanta Gastroenterology Associates
  • University of Chicago
  • University of Kentucky Medical Center
  • Johns Hopkins University
  • Metropolitan Gastroenterology Group
  • Massachusetts General Hospital, GI Unit
  • University of Michigan
  • Clinical Research Institute of Michigan
  • 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
  • Columbia Gastroenterology Associates
  • Memphis Gastroenterology Group
  • Vanderbilt University Medical Center
  • UT Southwestern Medical Center
  • University of Texas Medical Branch
  • University of Washington Medical Center
  • Medical College of Wisconsin
  • University of Wisconsin-Madison
  • Walter Mackenzie Health Sciences Centre
  • Gastroenterology & Hematology Clinic
  • St. Paul's Hospital
  • Hotel-Dieu Hospital
  • London Health Sciences Centre
  • London Health Sciences Centre
  • St. Michael's Hospital
  • Mount Sinai Hospital
  • Jewish General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Adacolumn

Sham

Arm Description

Adacolumn, ten apheresis sessions within 9 weeks

Sham, ten apheresis sessions within 9 weeks

Outcomes

Primary Outcome Measures

Clinical Remission
Clinical Remission is defined as a Crohn's Disease Activity Index (CDAI) score of ≤150 when evaluated at Week 12
Frequency and Severity of Adverse Events Through Week 12
All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis.

Secondary Outcome Measures

CDAI Score Change From Baseline
601-point, ordinal scale which quantifies the symptoms of patients with Crohn's Disease from 0 (complete remission) to 600 (most severe active disease). Mean change=Week 12 Mean CDAI-Baseline Mean CDAI
Clinical Response
Clinical Response is defined as a ≥ 100-point reduction in the CDAI scores at Week 12
Mean Change in Short-Form 36 Questionnaire (SF-36) Physical Component Summary (PCS) Score
101-point, ordinal scale measuring general health of patients from 0 (low quality of life) to 100 (high quality of life), Mean change=Week 12 Mean -Baseline Mean
Mean Change in Short-Form 36 Questionnaire (SF-36) Mental Component Summary (MCS) Score
101-point, ordinal scale measuring general health of patients from 0 (low quality of life) to 100 (high quality of life), Mean change=Week 12 Mean -Baseline Mean
Mean Change in Inflammatory Bowel Diseases Questionnaire (IBDQ)
193-point, ordinal scale measuring disease-specific quality of life from 32 (low quality of life) to 224 (high quality of life). Mean change= Week 12 Mean-Baseline Mean
Mean Change in EuroQol Score (Single Index)
A continuous scale that is a cardinal index of health from 0 (no impairment) to 1 (most impairment), Mean change=Week 12 Mean -Baseline Mean
Mean Change in EuroQol Score (Visual Analog Scale)
101-point, ordinal scale which measures non-disease specific health-related quality of life from 0 (Worst imaginable health state) to 100 (best imaginable health state)
Mean Change in Work Limitations Questionnaire (Time Management)
101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean
Mean Change in Work Limitations Questionnaire (Physical Demands)
101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean
Mean Change in Work Limitations Questionnaire (Mental-Interpersonal Demands)
101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean
Mean Change in Work Limitations Questionnaire (Output Demands)
101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean
Mean Change in Work Limitations Questionnaire (WLQ Index)
101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean
Mean Change in Crohn's Disease Endoscopic Index of Severity
26-point,ordinal scale that assesses the severity of Crohn's Disease from 0 (least severe) to 26 (most severe), Mean change=Week 12 Mean -Baseline Mean
Mean Change in Subject Global Rating
7-point,ordinal scale that measures the subject's state of Crohn's Disease from 0 (totally inactive) to 7 (as bad as it gets), Mean change=Week 12 Mean -Baseline Mean
Mean Change in C-Reactive Protein

Full Information

First Posted
September 9, 2005
Last Updated
March 5, 2009
Sponsor
Otsuka America Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT00162942
Brief Title
Study for the Treatment of Crohn's Disease 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 Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (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 evaluate the safety and effectiveness of the Adacolumn Apheresis System as a treatment for the signs and symptoms of Crohn's disease.
Detailed Description
Trial Features: Medical device (Non-drug option) Most patients can remain on current treatment regimen 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) Open-Label extension offered to eligible patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
235 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adacolumn
Arm Type
Active Comparator
Arm Description
Adacolumn, ten apheresis sessions within 9 weeks
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Sham, ten apheresis sessions within 9 weeks
Intervention Type
Device
Intervention Name(s)
Adacolumn
Intervention Description
Ten apheresis sessions: One hour of Adacolumn Apheresis System procedure per visit. Patient had two procedures per week for the first two weeks followed by one apheresis session per weeks for two weeks (Weeks 1-4). then a week break occurs for rest followed by one apheresis session per week for 4 weeks (weeks 6-9).
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
Sham, ten apheresis sessions within 9 weeks
Primary Outcome Measure Information:
Title
Clinical Remission
Description
Clinical Remission is defined as a Crohn's Disease Activity Index (CDAI) score of ≤150 when evaluated at Week 12
Time Frame
Baseline to Week 12
Title
Frequency and Severity of Adverse Events Through Week 12
Description
All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis.
Time Frame
Baseline through Week 12 Visit
Secondary Outcome Measure Information:
Title
CDAI Score Change From Baseline
Description
601-point, ordinal scale which quantifies the symptoms of patients with Crohn's Disease from 0 (complete remission) to 600 (most severe active disease). Mean change=Week 12 Mean CDAI-Baseline Mean CDAI
Time Frame
Baseline to Week 12
Title
Clinical Response
Description
Clinical Response is defined as a ≥ 100-point reduction in the CDAI scores at Week 12
Time Frame
Baseline to Week 12
Title
Mean Change in Short-Form 36 Questionnaire (SF-36) Physical Component Summary (PCS) Score
Description
101-point, ordinal scale measuring general health of patients from 0 (low quality of life) to 100 (high quality of life), Mean change=Week 12 Mean -Baseline Mean
Time Frame
Baseline to Week 12
Title
Mean Change in Short-Form 36 Questionnaire (SF-36) Mental Component Summary (MCS) Score
Description
101-point, ordinal scale measuring general health of patients from 0 (low quality of life) to 100 (high quality of life), Mean change=Week 12 Mean -Baseline Mean
Time Frame
Baseline to Week 12
Title
Mean Change in Inflammatory Bowel Diseases Questionnaire (IBDQ)
Description
193-point, ordinal scale measuring disease-specific quality of life from 32 (low quality of life) to 224 (high quality of life). Mean change= Week 12 Mean-Baseline Mean
Time Frame
Baseline to Week 12
Title
Mean Change in EuroQol Score (Single Index)
Description
A continuous scale that is a cardinal index of health from 0 (no impairment) to 1 (most impairment), Mean change=Week 12 Mean -Baseline Mean
Time Frame
Baseline to Week 12
Title
Mean Change in EuroQol Score (Visual Analog Scale)
Description
101-point, ordinal scale which measures non-disease specific health-related quality of life from 0 (Worst imaginable health state) to 100 (best imaginable health state)
Time Frame
Baseline to Week 12
Title
Mean Change in Work Limitations Questionnaire (Time Management)
Description
101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean
Time Frame
Baseline to Week 12
Title
Mean Change in Work Limitations Questionnaire (Physical Demands)
Description
101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean
Time Frame
Baseline to Week 12
Title
Mean Change in Work Limitations Questionnaire (Mental-Interpersonal Demands)
Description
101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean
Time Frame
Baseline to Week 12
Title
Mean Change in Work Limitations Questionnaire (Output Demands)
Description
101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean
Time Frame
Baseline to Week 12
Title
Mean Change in Work Limitations Questionnaire (WLQ Index)
Description
101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean
Time Frame
Baseline to Week 12
Title
Mean Change in Crohn's Disease Endoscopic Index of Severity
Description
26-point,ordinal scale that assesses the severity of Crohn's Disease from 0 (least severe) to 26 (most severe), Mean change=Week 12 Mean -Baseline Mean
Time Frame
Baseline to Week 12
Title
Mean Change in Subject Global Rating
Description
7-point,ordinal scale that measures the subject's state of Crohn's Disease from 0 (totally inactive) to 7 (as bad as it gets), Mean change=Week 12 Mean -Baseline Mean
Time Frame
Baseline to Week 12
Title
Mean Change in C-Reactive Protein
Time Frame
Baseline to week 12

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 Crohn's disease Adequate peripheral venous access 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: Extremely severe Crohn's disease Known obstructive symptoms within the past 3 months Presence of toxic megacolon Major surgery within the past 6 weeks or anticipated need for surgery within 12 weeks Total colectomy, ileostomy, stoma or 100 cm of resected small bowel 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 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
Capitol Gastroenterology Consultants Medical Group
City
Roseville
State/Province
California
ZIP/Postal Code
95661-3037
Country
United States
Facility Name
UCSF Mount Zion Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
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
Medical Research Institute of Connecticut
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Venture Research Institute, LLC
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
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
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
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 University
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
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
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
27710
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
Columbia Gastroenterology Associates
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Memphis Gastroenterology Group
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2285
Country
United States
Facility Name
UT Southwestern 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
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Medical College of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Walter Mackenzie Health Sciences Centre
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
Facility Name
Gastroenterology & Hematology Clinic
City
Abbotsford
State/Province
British Columbia
ZIP/Postal Code
V2S 3N5
Country
Canada
Facility Name
St. Paul's Hospital
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
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
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
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
22760005
Citation
Sands BE, Katz S, Wolf DC, Feagan BG, Wang T, Gustofson LM, Wong C, Vandervoort MK, Hanauer S. A randomised, double-blind, sham-controlled study of granulocyte/monocyte apheresis for moderate to severe Crohn's disease. Gut. 2013 Sep;62(9):1288-94. doi: 10.1136/gutjnl-2011-300995. Epub 2012 Jul 3.
Results Reference
derived

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Study for the Treatment of Crohn's Disease With Adacolumn

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