Status:
COMPLETED
A Study of MDX-1100 in Subjects With Active Ulcerative Colitis
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 admin...
Eligibility Criteria
Inclusion
- 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;
- prednisolone ≤ 20 mg daily (or equivalent) (dose must be stable for at least 2 weeks prior to study drug administration)
- 5-ASA (dose must be stable for at least 4 weeks prior to study drug administration)
- AZA or 6-MP (dose must be stable for at least 3 months prior to study drug administration)
- Rectal steroids or 5-ASA (must have been stable for at least 4 weeks prior to study drug)
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00656890
Start Date
April 1 2008
End Date
September 1 2009
Last Update
October 12 2015
Active Locations (44)
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1
Advanced Medical Research Center
Port Orange, Florida, United States, 32127
2
Florida Medical Clinic-Tampa Clinic
Tampa, Florida, United States, 33613
3
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
4
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815