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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Ulcerative Colitis
- Sponsor
- Otsuka America Pharmaceutical
- Enrollment
- 168
- Locations
- 37
- Primary Endpoint
- Safety will be evaluated by determining the frequency and severity of adverse events
- Status
- Completed
- Last Updated
- 17 years ago
Overview
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 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)
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Safety will be evaluated by determining the frequency and severity of adverse events
Effectiveness will be primarily evaluated at Week 12 by disease activity index (DAI) score