Study for the Treatment of Ulcerative Colitis With Adacolumn

Phase 3

Completed

• Conditions: Ulcerative Colitis

• Registration Number: NCT00102193
• Lead Sponsor: Otsuka America Pharmaceutical

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 Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-01-24
• Study First Submitted QC: 2005-01-24
• Study First Posted: 2005-01-25
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2008-04
• Last Update Submitted: 2008-09-05
• Last Update Posted: 2008-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (37)

Mayo Clinic Scottsdale; 🇺🇸 Phoenix, Arizona, United States

Providence Clinical Research; 🇺🇸 Burbank, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Rocky Mountain Gastroenterology Associates, PC; 🇺🇸 Wheat Ridge, Colorado, United States

Atlanta Gastroenterology Associates; 🇺🇸 Atlanta, Georgia, United States

University of Chicago, Department of Medicine, Section of Gastroenterology; 🇺🇸 Chicago, Illinois, United States

University of Kentucky Medical Center; 🇺🇸 Lexington, Kentucky, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Metropolitan Gastroenterology Group; 🇺🇸 Chevy Chase, Maryland, United States

Massachusetts General Hospital, GI Unit; 🇺🇸 Boston, Massachusetts, United States

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