Clinical trial NCT00162942: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Lead sponsor: Otsuka America Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Clinical Remission
timeFrame: Baseline to Week 12
measure: Frequency and Severity of Adverse Events Through Week 12
timeFrame: Baseline through Week 12 Visit
Secondary outcomes:
measure: CDAI Score Change From Baseline
timeFrame: Baseline to Week 12
measure: Clinical Response
timeFrame: Baseline to Week 12
measure: Mean Change in Short-Form 36 Questionnaire (SF-36) Physical Component Summary (PCS) Score
timeFrame: Baseline to Week 12
measure: Mean Change in Short-Form 36 Questionnaire (SF-36) Mental Component Summary (MCS) Score
timeFrame: Baseline to Week 12
measure: Mean Change in Inflammatory Bowel Diseases Questionnaire (IBDQ)
timeFrame: Baseline to Week 12
measure: Mean Change in EuroQol Score (Single Index)
timeFrame: Baseline to Week 12
measure: Mean Change in EuroQol Score (Visual Analog Scale)
timeFrame: Baseline to Week 12
measure: Mean Change in Work Limitations Questionnaire (Time Management)
timeFrame: Baseline to Week 12
measure: Mean Change in Work Limitations Questionnaire (Physical Demands)
timeFrame: Baseline to Week 12
measure: Mean Change in Work Limitations Questionnaire (Mental-Interpersonal Demands)
timeFrame: Baseline to Week 12
measure: Mean Change in Work Limitations Questionnaire (Output Demands)
timeFrame: Baseline to Week 12
measure: Mean Change in Work Limitations Questionnaire (WLQ Index)
timeFrame: Baseline to Week 12
measure: Mean Change in Crohn's Disease Endoscopic Index of Severity
timeFrame: Baseline to Week 12
measure: Mean Change in Subject Global Rating
timeFrame: Baseline to Week 12
measure: Mean Change in C-Reactive Protein
timeFrame: Baseline to week 12
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Scottsdale
state: Arizona
city: Roseville
country: United States
facility: Capitol Gastroenterology Consultants Medical Group
state: California
city: San Francisco
country: United States
facility: UCSF Mount Zion Medical Center
state: California
city: Wheat Ridge
country: United States
facility: Rocky Mountain Gastroenterology Associates, PC
state: Colorado
city: Hamden
country: United States
facility: Medical Research Institute of Connecticut
state: Connecticut
city: North Miami Beach
country: United States
facility: Venture Research Institute, LLC
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Chevy Chase
country: United States
facility: Metropolitan Gastroenterology Group
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital, GI Unit
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Clinton Township
country: United States
facility: Clinical Research Institute of Michigan
state: Michigan
city: Lebanon,
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina, Division of Digestive Disease & Nutrition
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbia
country: United States
facility: Columbia Gastroenterology Associates
state: South Carolina
city: Germantown
country: United States
facility: Memphis Gastroenterology Group
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Madison
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
city: Edmonton
country: Canada
facility: Walter Mackenzie Health Sciences Centre
state: Alberta
city: Abbotsford
country: Canada
facility: Gastroenterology & Hematology Clinic
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Kingston
country: Canada
facility: Hotel-Dieu Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Otsuka America Pharmaceutical
name: Yosuke Komatsu, MD, PhD
role: STUDY_DIRECTOR
References:
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.