Expired Study
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Dayton, Ohio 45415


Purpose:

The purpose of this study is to determine the safety and tolerability of the MDX-1100 regimen in subjects with active Ulcerative colitis(UC) and determine the response rate at day 57 in patients administered MDX-1100.


Criteria:

Inclusion Criteria: - Subjects with active UC on either 5-ASA,corticosteroids,azathioprine(AZA) and or/6-mercaptopurine(6-MP); - Mayo score of 6 to 10 points with moderate to severe disease on endoscopy - Subjects on the following medications; 1. prednisolone ≤ 20 mg daily (or equivalent) (dose must be stable for at least 2 weeks prior to study drug administration) 2. 5-ASA (dose must be stable for at least 4 weeks prior to study drug administration) 3. AZA or 6-MP (dose must be stable for at least 3 months prior to study drug administration) 4. Rectal steroids or 5-ASA (must have been stable for at least 4 weeks prior to study drug) Exclusion Criteria: - Anti-TNF therapy within 8 weeks before study drug administration - Contraindication to colonoscopy or sigmoidoscopy - Primary or secondary immunodeficiency - Autoimmune disease besides UC, with the exceptions of Sjogren's syndrome or hypothyroidism - History of malignancy, excluding adequately treated and cured basal or squamous cell of the skin, or cervical carcinoma in situ - Evidence of acute or chronic infection - Clinically significant disease requiring medication


NCT ID:

NCT00656890


Primary Contact:

Study Director
Bristol-Myers Squibb
Bristol-Myers Squibb


Backup Contact:

N/A


Location Contact:

Dayton, Ohio 45415
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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