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The purpose of this study is to assess the safety, effectiveness and pharmacokinetics of two levels of intravenous basiliximab in ulcerative colitis, compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Placebo | Placebo Comparator | Placebo to mimic 40 mg of Simulect |
|
| 2. 40 mg Simulect | Experimental | 40 mg of Simulect |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Basiliximab | Drug | 3 doses of 40mg, IV at baseline, week 2, and week 4 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mayo Score, Safety | At week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical remission at week 4; clinical response at weeks 4 and 8; use of rescue medication; hospitalization or colectomy; and concomitant steroid use | at week 4 and 8 |
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Inclusion Criteria:
In addition to others,
Exclusion Criteria:
In addition to other protocol-defined conditions,
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Levitt, MD, PhD | Cerimon Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22549092 | Derived | Sands BE, Sandborn WJ, Creed TJ, Dayan CM, Dhanda AD, Van Assche GA, Gregus M, Sood A, Choudhuri G, Stempien MJ, Levitt D, Probert CS. Basiliximab does not increase efficacy of corticosteroids in patients with steroid-refractory ulcerative colitis. Gastroenterology. 2012 Aug;143(2):356-64.e1. doi: 10.1053/j.gastro.2012.04.043. Epub 2012 Apr 28. |
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| Roseville |
| California |
| 95661 |
| United States |
| Golden | Colorado | United States |
| Littleton | Colorado | United States |
| Hollywood | Florida | United States |
| Jacksonville | Florida | United States |
| Winter Park | Florida | 32789 | United States |
| Atlanta | Georgia | United States |
| Chicago | Illinois | 60637 | United States |
| Urbana | Illinois | 61801 | United States |
| Indianapolis | Indiana | 46202 | United States |
| Topeka | Kansas | 66606 | United States |
| Lexington | Kentucky | 40536 | United States |
| Boston | Massachusetts | 02114 | United States |
| Troy | Michigan | United States |
| Egg Harbor Twp | New Jersey | 08234 | United States |
| Great Neck | New York | United States |
| New York | New York | United States |
| Fargo | North Dakota | 58104 | United States |
| Cleveland | Ohio | 44195 | United States |
| Sewickley | Pennsylvania | 15143 | United States |
| Germantown | Tennessee | United States |
| Fort Worth | Texas | 76104 | United States |
| Galveston | Texas | United States |
| Houston | Texas | 77090 | United States |
| Leuven | 3000 | Belgium |
| Mladá Boleslav | 293 50 | Czechia |
| Prague | 100 34 | Czechia |
| Prague | 170 00 | Czechia |
| Prague | Czechia |
| Tábor | 390 03 | Czechia |
| Ústí nad Orlicí | 562 18 | Czechia |
| Bangalore | 560 054 | India |
| Hyderabaad | 500012 | India |
| Kochi | 682017 | India |
| Kolkata | 700020 | India |
| Lucknow | 226014 | India |
| Ludhiana | 141001 | India |
| Mumbai | 400016 | India |
| New Delhi | 110076 | India |
| Visakhapatnam | 530 002 | India |
| Gdansk | Poland |
| Krakow | 31-826 | Poland |
| Krakow | Poland |
| Poznan | 60-353 | Poland |
| Sopot | 81-756 | Poland |
| Sopot | 81-820 | Poland |
| Warsaw | 02-098 | Poland |
| Wroclaw | 54-144 | Poland |
| Moscow | 115446 | Russia |
| Moscow | 121309 | Russia |
| Samara | 443011 | Russia |
| Smolensk | 214001 | Russia |
| Bratislava | 811 07 | Slovakia |
| Bratislava | 851 01 | Slovakia |
| Nitra | 949 01 | Slovakia |
| Nové Mesto nad Váhom | 915 01 | Slovakia |
| Prešov | 080 01 | Slovakia |
| Dnipro | 49074 | Ukraine |
| Ivano-Frankivsk | 76000 | Ukraine |
| Kharkiv | 61037 | Ukraine |
| Kyiv | 01021 | Ukraine |
| Kyiv | 04210 | Ukraine |
| Bristol | BS2 8HW | United Kingdom |
| Derbyshire | DE22 3NE | United Kingdom |
| London | WC1E 6DB | United Kingdom |
| Stoke-on-Trent | ST4 6QB | United Kingdom |
| Wigan | WN1 2NN | United Kingdom |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000077552 | Basiliximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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