Study for the Treatment of Crohn's Disease With Adacolumn - Full Text View

Sponsored by:	Otsuka America Pharmaceutical
Information provided by:	Otsuka America Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00162942

Purpose

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 Device: Sham	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

U.S. FDA Resources

Further study details as provided by Otsuka America Pharmaceutical:

Primary Outcome Measures:

Clinical Remission [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Frequency and Severity of Adverse Events Through Week 12 [ Time Frame: Baseline through Week 12 Visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

CDAI Score Change From Baseline [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Clinical Response [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Mean Change in Short-Form 36 Questionnaire (SF-36) Physical Component Summary (PCS) Score [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Mean Change in Short-Form 36 Questionnaire (SF-36) Mental Component Summary (MCS) Score [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Mean Change in Inflammatory Bowel Diseases Questionnaire (IBDQ) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Mean Change in EuroQol Score (Single Index) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Mean Change in EuroQol Score (Visual Analog Scale) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Mean Change in Work Limitations Questionnaire (Time Management) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Mean Change in Work Limitations Questionnaire (Physical Demands) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Mean Change in Work Limitations Questionnaire (Mental-Interpersonal Demands) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Mean Change in Work Limitations Questionnaire (Output Demands) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Mean Change in Work Limitations Questionnaire (WLQ Index) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Mean Change in Crohn's Disease Endoscopic Index of Severity [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Mean Change in Subject Global Rating [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Mean Change in C-Reactive Protein [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]

Enrollment:	235
Study Start Date:	January 2005
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Adacolumn: Active Comparator Adacolumn, ten apheresis sessions within 9 weeks	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 Comparator Sham, ten apheresis sessions within 9 weeks	Device: Sham Sham, ten apheresis sessions within 9 weeks

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162942

Show 37 Study Locations

Sponsors and Collaborators

Otsuka America Pharmaceutical

Investigators

Study Director:

Yosuke Komatsu, MD, PhD

Otsuka America Pharmaceutical

More Information

Additional Information:

Sponsor

Manufacturer's site in Japan This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Otsuka America Pharmaceutical, Inc ( Tao Wang / Director of Medical Affairs )
Study ID Numbers:	512-04-206
Study First Received:	September 9, 2005
Results First Received:	January 15, 2009
Last Updated:	March 5, 2009
ClinicalTrials.gov Identifier:	NCT00162942 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Otsuka America Pharmaceutical:

Crohn's Disease

Study placed in the following topic categories:

Crohn's Disease
Digestive System Diseases
Gastrointestinal Diseases
Ileitis
Enteritis

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases
Ileal Diseases

Additional relevant MeSH terms:

Digestive System Diseases
Gastrointestinal Diseases
Ileitis
Enteritis
Crohn Disease

Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Ileal Diseases

ClinicalTrials.gov processed this record on September 11, 2009