Study for the Treatment of Crohn's Disease With Adacolumn

Phase 3

Completed

Conditions: Crohn's Disease

Interventions: Device: Adacolumn
Device: Sham

Registration Number: NCT00162942

Lead Sponsor: Otsuka America Pharmaceutical

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 235

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adacolumn	Adacolumn	Adacolumn, ten apheresis sessions within 9 weeks
Sham	Sham	Sham, ten apheresis sessions within 9 weeks

Primary Outcome Measures

Name	Time	Method
Clinical Remission	Baseline to Week 12	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	Baseline through Week 12 Visit	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

Name	Time	Method
CDAI Score Change From Baseline	Baseline to Week 12	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	Baseline to Week 12	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	Baseline to Week 12	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	Baseline to Week 12	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)	Baseline to Week 12	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)	Baseline to Week 12	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)	Baseline to Week 12	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)	Baseline to Week 12	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)	Baseline to Week 12	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)	Baseline to Week 12	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)	Baseline to Week 12	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)	Baseline to Week 12	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	Baseline to Week 12	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	Baseline to Week 12	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	Baseline to week 12

Trial Locations

Locations (36): Medical Research Institute of Connecticut
🇺🇸
Hamden, Connecticut, United States
Dartmouth-Hitchcock Medical Center
🇺🇸
Lebanon,, New Hampshire, United States
Memphis Gastroenterology Group
🇺🇸
Germantown, Tennessee, United States
Medical College of Wisconsin
🇺🇸
Madison, Wisconsin, United States
Walter Mackenzie Health Sciences Centre
🇨🇦
Edmonton, Alberta, Canada
University of Wisconsin-Madison
🇺🇸
Madison, Wisconsin, United States
Gastroenterology & Hematology Clinic
🇨🇦
Abbotsford, British Columbia, Canada
Venture Research Institute, LLC
🇺🇸
North Miami Beach, Florida, United States
University of Kentucky Medical Center
🇺🇸
Lexington, Kentucky, United States
Metropolitan Gastroenterology Group
🇺🇸
Chevy Chase, Maryland, United States
Capitol Gastroenterology Consultants Medical Group
🇺🇸
Roseville, California, United States
Rocky Mountain Gastroenterology Associates, PC
🇺🇸
Wheat Ridge, Colorado, United States
Clinical Research Institute of Michigan
🇺🇸
Clinton Township, Michigan, United States
London Health Sciences Centre
🇨🇦
London, Ontario, Canada
Mayo Clinic Scottsdale
🇺🇸
Phoenix, Arizona, United States
UCSF Mount Zion Medical Center
🇺🇸
San Francisco, California, United States
Atlanta Gastroenterology Associates
🇺🇸
Atlanta, Georgia, United States
University of Chicago
🇺🇸
Chicago, Illinois, United States
Johns Hopkins University
🇺🇸
Baltimore, Maryland, United States
Massachusetts General Hospital, GI Unit
🇺🇸
Boston, Massachusetts, United States
Long Island Clinical Research Associates
🇺🇸
Great Neck, New York, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Consultants for Clinical Research
🇺🇸
Cincinnati, Ohio, United States
Columbia Gastroenterology Associates
🇺🇸
Columbia, South Carolina, United States
Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States
UT Southwestern Medical Center
🇺🇸
Dallas, Texas, United States
Hotel-Dieu Hospital
🇨🇦
Kingston, Ontario, Canada
St. Michael's Hospital
🇨🇦
Toronto, Ontario, Canada
University of Texas Medical Branch
🇺🇸
Galveston, Texas, United States
Mount Sinai Hospital
🇨🇦
Toronto, Ontario, Canada
University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
University of North Carolina, Division of Digestive Disease & Nutrition
🇺🇸
Chapel Hill, North Carolina, United States
University of Washington Medical Center
🇺🇸
Seattle, Washington, United States
St. Paul's Hospital
🇨🇦
Vancouver, British Columbia, Canada
Jewish General Hospital
🇨🇦
Montreal, Quebec, Canada