NCT00102193CompletedPhase 3
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
Otsuka America Pharmaceutical37 sites in 2 countries168 target enrollmentStarted: July 1, 2004Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 168
- Locations
- 37
- Primary Endpoint
- Safety will be evaluated by determining the frequency and severity of adverse events
Study 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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (37)
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