Study for the Treatment of Crohn's Disease With Adacolumn
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
1 other identifier
interventional
235
2 countries
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2005
Typical duration for phase_3
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 13, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedResults Posted
Study results publicly available
April 7, 2009
CompletedApril 7, 2009
March 1, 2009
2.9 years
September 9, 2005
January 15, 2009
March 5, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Clinical Remission
Clinical Remission is defined as a Crohn's Disease Activity Index (CDAI) score of ≤150 when evaluated at Week 12
Baseline to 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.
Baseline through Week 12 Visit
Secondary Outcomes (15)
CDAI Score Change From Baseline
Baseline to Week 12
Clinical Response
Baseline to Week 12
Mean Change in Short-Form 36 Questionnaire (SF-36) Physical Component Summary (PCS) Score
Baseline to Week 12
Mean Change in Short-Form 36 Questionnaire (SF-36) Mental Component Summary (MCS) Score
Baseline to Week 12
Mean Change in Inflammatory Bowel Diseases Questionnaire (IBDQ)
Baseline to Week 12
- +10 more secondary outcomes
Study Arms (2)
Adacolumn
ACTIVE COMPARATORAdacolumn, ten apheresis sessions within 9 weeks
Sham
SHAM COMPARATORSham, ten apheresis sessions within 9 weeks
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Mayo Clinic Scottsdale
Phoenix, Arizona, 85054, United States
Capitol Gastroenterology Consultants Medical Group
Roseville, California, 95661-3037, United States
UCSF Mount Zion Medical Center
San Francisco, California, 94115, United States
Rocky Mountain Gastroenterology Associates, PC
Wheat Ridge, Colorado, 80033, United States
Medical Research Institute of Connecticut
Hamden, Connecticut, 06518, United States
Venture Research Institute, LLC
North Miami Beach, Florida, 33162, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342, United States
University of Chicago
Chicago, Illinois, 60637, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Metropolitan Gastroenterology Group
Chevy Chase, Maryland, 20815, United States
Massachusetts General Hospital, GI Unit
Boston, Massachusetts, 02114, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Clinical Research Institute of Michigan
Clinton Township, Michigan, 48047, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Long Island Clinical Research Associates
Great Neck, New York, 11021, United States
University of North Carolina, Division of Digestive Disease & Nutrition
Chapel Hill, North Carolina, 27710, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Consultants for Clinical Research
Cincinnati, Ohio, 45219, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Columbia Gastroenterology Associates
Columbia, South Carolina, 29203, United States
Memphis Gastroenterology Group
Germantown, Tennessee, 38138, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-2285, United States
UT Southwestern Medical Center
Dallas, Texas, 75390-9016, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Medical College of Wisconsin
Madison, Wisconsin, 53226, United States
University of Wisconsin-Madison
Madison, Wisconsin, 53792, United States
Walter Mackenzie Health Sciences Centre
Edmonton, Alberta, T6G 2X8, Canada
Gastroenterology & Hematology Clinic
Abbotsford, British Columbia, V2S 3N5, Canada
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
Hotel-Dieu Hospital
Kingston, Ontario, K7L 5G2, Canada
London Health Sciences Centre
London, Ontario, N6A 4G5, Canada
London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Related Publications (1)
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.
PMID: 22760005DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tao Wang
- Organization
- Otsuka America Pharmaceutical, Inc
Study Officials
- STUDY DIRECTOR
Yosuke Komatsu, MD, PhD
Otsuka America Pharmaceutical
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 13, 2005
Study Start
January 1, 2005
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
April 7, 2009
Results First Posted
April 7, 2009
Record last verified: 2009-03