Study for the Treatment of Ulcerative Colitis With Adacolumn

Study Overview
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Brief Summary
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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
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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)

Official Title
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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

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Device: Adacolumn Apheresis System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Adacolumn Apheresis System|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative Colitis, Apheresis