Clinical Trial: Study for the Treatment of Ulcerative Colitis With Adacolumn

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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)

Sponsor: Otsuka America Pharmaceutical

Current Primary Outcome:

  • 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Otsuka America Pharmaceutical

Dates:
Date Received: January 24, 2005
Date Started: July 2004
Date Completion:
Last Updated: September 5, 2008
Last Verified: April 2008