Study for the Treatment of Crohn's Disease With Adacolumn

This study has been completed.
Sponsor:
Information provided by:
Otsuka America Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00162942
First received: September 9, 2005
Last updated: March 5, 2009
Last verified: March 2009
  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 3

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


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
Active Comparator: Adacolumn
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 Comparator: Sham
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided by Otsuka America Pharmaceutical

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

Keywords provided by Otsuka America Pharmaceutical:
Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 28, 2014