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.

Condition	Intervention	Phase
Crohn’s Disease	Device: Adacolumn Apheresis System	Phase III

Further Study Details: 

Primary Outcomes: Primary effectiveness will be evaluated at Week 12 by Crohn''''s disease activity index (CDAI) score; Safety will be evaluated by determining the frequency and severity of adverse events
Expected Total Enrollment:  234

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

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00162942

Tara Clayton      1-866-560-5828    adacolumn@robarts.ca
Robarts Clincal Trials    

Arizona
      Mayo Clinic Scottsdale, Phoenix,  Arizona,  85054,  United States; Recruiting
Illinois
      University of Chicago, Chicago,  Illinois,  60637,  United States; Recruiting
New York
      Long Island Clinical Research Associates, Great Neck,  New York,  11021,  United States; Recruiting
      Dartmouth-Hitchcock Medical Center, Lebanon,  New York,  03756,  United States; Recruiting
Ohio
      Consultants for Clinical Research, Cincinnati,  Ohio,  45219,  United States; Recruiting
Texas
      UT Southwestern Medical Center, Dallas,  Texas,  75390-9016,  United States; Recruiting

Study ID Numbers:  512-04-206
Last Updated:  September 12, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00162942
Health Authority: United States: Food and Drug Administration; Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-09-13