A Study of MDX-1100 in Subjects With Active Ulcerative Colitis
NCT00656890 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2015-10-12
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 administered MDX-1100.
Conditions
Interventions
- BIOLOGICAL
-
sterile saline for injection
10mg/kg/dose sterile saline injected every other week for a total of 4 doses
- BIOLOGICAL
-
MDX-1100
10mg/kg/dose MDX-1100 injected every other week for a total of 4 doses
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-04-30
- Primary Completion
- 2009-09-30
- Completion
- 2009-09-30
Countries
- United States
- Canada
- Czechia
- Hungary
- Latvia
- Romania
- Russia
- Ukraine
Study Locations
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