Study for the Treatment of Ulcerative Colitis With Adacolumn

This study has been completed.
Sponsor:
Information provided by:
Otsuka America Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00102193
First received: January 24, 2005
Last updated: September 5, 2008
Last verified: April 2008
  Purpose

The purpose of this study is to demonstrate the safety and effectiveness of the Adacolumn Apheresis System to treat the signs and symptoms of ulcerative colitis.


Condition Intervention Phase
Ulcerative Colitis
Device: Adacolumn Apheresis System
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Otsuka America Pharmaceutical:

Primary Outcome Measures:
  • Effectiveness will be primarily evaluated at Week 12 by disease activity index (DAI) score
  • Safety will be evaluated by determining the frequency and severity of adverse events

Estimated Enrollment: 168
Study Start Date: July 2004
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Trial Features:

  • Non-drug therapy
  • Most patients can remain on current treatment regimen, including prednisone, budesonide and medications such as Asacol (mesalamine), Pentasa (mesalamine), Colazal (balsalazide disodium) and Dipentum (olsalazine sodium) 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)
  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 active ulcerative colitis with colonic involvement with ulcerative colitis beyond 15 cm of the anal verge
  • Adequate peripheral venous access to allow for completion of the apheresis treatments
  • Receiving one or more of the following medical therapies:

    *sulfasalazine, *mesalamine and other 5-ASA agents, *prednisone or 6-mercaptopurine or azathioprine OR Have not received the above medical therapies due to intolerance or demonstrated non-response

  • 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:

  • Evidence of toxic megacolon
  • Major surgery within the past 6 weeks or anticipated need for surgery within 12 weeks
  • Proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis
  • 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
  • Insulin-dependent Type I or Type II diabetes
  • 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: NCT00102193

  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

ClinicalTrials.gov Identifier: NCT00102193     History of Changes
Other Study ID Numbers: 512-04-205
Study First Received: January 24, 2005
Last Updated: September 5, 2008
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Otsuka America Pharmaceutical:
Ulcerative Colitis, Apheresis

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 22, 2014