A Study of MDX-1100 in Subjects With Active Ulcerative Colitis
NCT ID: NCT00656890
Last Updated: 2015-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
110 participants
INTERVENTIONAL
2008-04-30
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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2
sterile saline for injection
sterile saline for injection
10mg/kg/dose sterile saline injected every other week for a total of 4 doses
1
MDX-1100 for injection
MDX-1100
10mg/kg/dose MDX-1100 injected every other week for a total of 4 doses
Interventions
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sterile saline for injection
10mg/kg/dose sterile saline injected every other week for a total of 4 doses
MDX-1100
10mg/kg/dose MDX-1100 injected every other week for a total of 4 doses
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Abbotsford, British Columbia, Canada
Vancouver, British Columbia, Canada
Toronto, Ontario, Canada
Olomouc, , Czechia
Prague, , Czechia
Strakonice, , Czechia
Tábor, , Czechia
Ústí nad Labem, , Czechia
Valasske Mezifici, , Czechia
Budapest, , Hungary
Debrecen, , Hungary
Gyula, , Hungary
Kaposvár, , Hungary
Kecskemét, , Hungary
Nagykanizsa, , Hungary
Siófok, , Hungary
Vác, , Hungary
Zalaegerszeg, , Hungary
Daugavpils, , Latvia
Riga, , Latvia
Valmiera, , Latvia
Bucharest, , Romania
Cluj-Napoca, , Romania
Oradea, , Romania
Tg. Mures, , Romania
Timișoara, , Romania
Moscow, , Russia
Saratov, , Russia
Yaroslavl, , Russia
Chernivtsy, , Ukraine
Dniepropetrovsk, , Ukraine
Donetsk, , Ukraine
Kharkiv, , Ukraine
Kiev, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Simferopol, , Ukraine
Countries
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References
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Mayer L, Sandborn WJ, Stepanov Y, Geboes K, Hardi R, Yellin M, Tao X, Xu LA, Salter-Cid L, Gujrathi S, Aranda R, Luo AY. Anti-IP-10 antibody (BMS-936557) for ulcerative colitis: a phase II randomised study. Gut. 2014 Mar;63(3):442-50. doi: 10.1136/gutjnl-2012-303424. Epub 2013 Mar 5.
Other Identifiers
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IM129-004
Identifier Type: OTHER
Identifier Source: secondary_id
MDX1100-06
Identifier Type: -
Identifier Source: org_study_id
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