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| ID | Type | Description | Link |
|---|---|---|---|
| GA00930 | Other Identifier | Hoffmann-La Roche |
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This is a randomized , double-blind, placebo-controlled study of approximately 70 patients with ulcerative colitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | Intravenous and subcutaneous escalating doses |
| |
| rhuMAb Beta7 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and nature of laboratory abnormalities | Through study completion or early study discontinuation | |
| Incidence, nature, and severity of adverse events | Through study completion or early study discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| PK profile and parameters | Through study completion or early study discontinuation | |
| Incidence of antibodies directed against rhuMAb Beta7 | Through study completion or early study discontinuation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anniston | Alabama | 36207 | United States | |||
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| Drug |
Intravenous and subcutaneous escalating doses |
|
| San Francisco |
| California |
| 94115 |
| United States |
| Gainesville | Florida | 32610 | United States |
| Atlanta | Georgia | 30308 | United States |
| Lexington | Kentucky | 40536 | United States |
| Rochester | Minnesota | 55905 | United States |
| Great Neck | New York | 11021 | United States |
| Chapel Hill | North Carolina | 27599 | United States |
| Leuven | 3000 | Belgium |
| Calgary | Alberta | T2N 2T9 | Canada |
| Edmonton | Alberta | T6G 2X8 | Canada |
| Vancouver | British Columbia | V6Z 2K5 | Canada |
| Victoria | British Columbia | V8V 3P9 | Canada |
| London | Ontario | N6A 4L6 | Canada |
| Montreal | Quebec | H1T 2M4 | Canada |
| Berlin | 13353 | Germany |
| Frankfurt | 60431 | Germany |
| Kiel | 24105 | Germany |
| Regensburg | 93053 | Germany |
| Ulm | 89081 | Germany |
| Leiden | 2333 ZA | Netherlands |
| Maastricht | 6229 HX | Netherlands |
| Nijmegen | 6525 GA | Netherlands |
| Utrecht | 3584 CX | Netherlands |
| Bristol | BS2 8HW | United Kingdom |
| London | SE1 7EH | United Kingdom |
| London | SW10 9NH | United Kingdom |
| London | W12 0HS | United Kingdom |
| Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Nottingham | NG7 2UH | 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 |
|---|---|
| C559198 | etrolizumab |
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