Study for the Treatment of Crohn's Disease With Adacolumn
Crohn's Disease
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease
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
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
Active Comparator
Sham Comparator
Adacolumn
Sham
Adacolumn, ten apheresis sessions within 9 weeks
Sham, ten apheresis sessions within 9 weeks