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| ID | Type | Description | Link |
|---|---|---|---|
| IM129-004 | Other Identifier | BMS |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Placebo Comparator | sterile saline for injection |
|
| 1 | Experimental | MDX-1100 for injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sterile saline for injection | Biological | 10mg/kg/dose sterile saline injected every other week for a total of 4 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mayo score at Day 57 compared with Screening | Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| the remission rate | Day 57 |
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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;
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Medical Research Center | Port Orange | Florida | 32127 | United States | ||
| Florida Medical Clinic-Tampa Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23461895 | Derived | 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. |
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| MDX-1100 | Biological | 10mg/kg/dose MDX-1100 injected every other week for a total of 4 doses |
|
| Tampa |
| Florida |
| 33613 |
| United States |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Dayton Science Institute | Dayton | Ohio | 45415 | United States |
| Abbotsford British Columbia | British Columbia | V2S 3N5 | Canada |
| Vancouver | British Columbia | V5Z 1H2 | Canada |
| Toronto | Ontario | M3N 2V7 | 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 |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007267 | Injections |
| C574193 | MDX-1100 |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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