A Study of MDX-1100 in Subjects With Active Ulcerative Colitis

Completed · Phase 2

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT00656890

Run by

Bristol-Myers Squibb

People needed

110

Starts

2008-04-01

Expected to finish

2009-09-01

Last updated by the study team

2015-10-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Advanced Medical Research Center — Port Orange, Florida, United States
• Florida Medical Clinic-Tampa Clinic — Tampa, Florida, United States
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
• Chevy Chase Clinical Research — Chevy Chase, Maryland, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Dayton Science Institute — Dayton, Ohio, United States
• Study site — Abbotsford British Columbia, British Columbia, Canada
• Study site — Vancouver, British Columbia, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Olomouc, Czechia
• Study site — Prague, Czechia
• Study site — Strakonice, Czechia
• Study site — Tábor, Czechia
• Study site — Ústí nad Labem, Czechia
• Study site — Valasske Mezifici, Czechia
• Study site — Budapest, Hungary
• Study site — Debrecen, Hungary
• Study site — Gyula, Hungary
• Study site — Kaposvár, Hungary
• Study site — Kecskemét, Hungary
• Study site — Nagykanizsa, Hungary
• Study site — Siófok, Hungary
• Study site — Vác, Hungary
• Study site — Zalaegerszeg, Hungary

Full record on ClinicalTrials.gov

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