Study for the Treatment of Crohn's Disease With Adacolumn

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00162942
• Other study ID #: 512-04-206
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: March 5, 2009
• Start date: January 2005
• Est. completion date: December 2007

Study information

• Verified date: March 2009
• Source: Otsuka America Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Device:
• Adacolumn
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).
• Sham
Sham, ten apheresis sessions within 9 weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka America Pharmaceutical

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Remission		Baseline to Week 12	No
Primary	Frequency and Severity of Adverse Events Through Week 12		Baseline through Week 12 Visit	Yes
Secondary	CDAI Score Change From Baseline		Baseline to Week 12	No
Secondary	Clinical Response		Baseline to Week 12	No
Secondary	Mean Change in Short-Form 36 Questionnaire (SF-36) Physical Component Summary (PCS) Score		Baseline to Week 12	No
Secondary	Mean Change in Short-Form 36 Questionnaire (SF-36) Mental Component Summary (MCS) Score		Baseline to Week 12	No
Secondary	Mean Change in Inflammatory Bowel Diseases Questionnaire (IBDQ)		Baseline to Week 12	No
Secondary	Mean Change in EuroQol Score (Single Index)		Baseline to Week 12	No
Secondary	Mean Change in EuroQol Score (Visual Analog Scale)		Baseline to Week 12	No
Secondary	Mean Change in Work Limitations Questionnaire (Time Management)		Baseline to Week 12	No
Secondary	Mean Change in Work Limitations Questionnaire (Physical Demands)		Baseline to Week 12	No
Secondary	Mean Change in Work Limitations Questionnaire (Mental-Interpersonal Demands)		Baseline to Week 12	No
Secondary	Mean Change in Work Limitations Questionnaire (Output Demands)		Baseline to Week 12	No
Secondary	Mean Change in Work Limitations Questionnaire (WLQ Index)		Baseline to Week 12	No
Secondary	Mean Change in Crohn's Disease Endoscopic Index of Severity		Baseline to Week 12	No
Secondary	Mean Change in Subject Global Rating		Baseline to Week 12	No
Secondary	Mean Change in C-Reactive Protein		Baseline to week 12	No

External Links

•   Manufacturer's site in Japan