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| ID | Type | Description | Link |
|---|---|---|---|
| GP27778 | Other Identifier | Hoffmann-La Roche |
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This Phase II study is a randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of rhuMAb Beta7 in patients with moderate to severe ulcerative colitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rhuMAb Beta7 | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | Repeating subcutaneous injection |
| |
| rhuMAb Beta7 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point | Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response as defined by at least a 3-point decrease and 30% reduction from baseline in MCS and a >/=1-point decrease in rectal bleeding subscore or absolute rectal bleeding score of 0 or 1 | Week 6 and Week 10 | |
| Clinical remission defined by a MCS </= 2 with no individual subscore exceeding 1 point |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon O'Byrne, M.D. | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego | California | 92103 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24814090 | Derived | Vermeire S, O'Byrne S, Keir M, Williams M, Lu TT, Mansfield JC, Lamb CA, Feagan BG, Panes J, Salas A, Baumgart DC, Schreiber S, Dotan I, Sandborn WJ, Tew GW, Luca D, Tang MT, Diehl L, Eastham-Anderson J, De Hertogh G, Perrier C, Egen JG, Kirby JA, van Assche G, Rutgeerts P. Etrolizumab as induction therapy for ulcerative colitis: a randomised, controlled, phase 2 trial. Lancet. 2014 Jul 26;384(9940):309-18. doi: 10.1016/S0140-6736(14)60661-9. Epub 2014 May 9. |
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| Drug |
Repeating subcutaneous injection |
|
| Week 6 |
| Proportion of patients with endoscopic score and rectal bleeding score of 0 | Week 6 and Week 10 |
| Gainesville |
| Florida |
| 32610 |
| United States |
| Atlanta | Georgia | 30308 | United States |
| Chevy Chase | Maryland | 20815 | United States |
| Ann Arbor | Michigan | 48109-0682 | United States |
| Rochester | Minnesota | 55905 | United States |
| Great Neck | New York | 11021 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Garran | Australian Capital Territory | 2605 | Australia |
| Clayton | Victoria | 3168 | Australia |
| Fitzroy | Victoria | 3065 | Australia |
| Melbourne | Victoria | 3181 | Australia |
| Parkville | Victoria | 3050 | Australia |
| Bonheiden | 2820 | Belgium |
| Ghent | 9000 | Belgium |
| Leuven | 3000 | Belgium |
| Liège | 4000 | Belgium |
| Edmonton | Alberta | T6G 2X8 | Canada |
| Edmonton | Alberta | V6Z 1Y6 | Canada |
| London | Ontario | N6A 5W9 | Canada |
| Woodbridge | Ontario | L4L 4Y7 | Canada |
| Hradec Králové | 500 12 | Czechia |
| Náchod | 547 01 | Czechia |
| Ostrava - Poruba | 708 52 | Czechia |
| Zlín | 762 75 | Czechia |
| Berlin | 13353 | Germany |
| Hanover | 30625 | Germany |
| Kiel | 24105 | Germany |
| Minden | 32423 | Germany |
| Ulm | 89081 | Germany |
| Budapest | 1073 | Hungary |
| Budapest | 1136 | Hungary |
| Gyöngyös | 3200 | Hungary |
| Győr | 9024 | Hungary |
| Mosonmagyaróvár | 9200 | Hungary |
| Beersheba | 84105 | Israel |
| Haifa | 31096 | Israel |
| Jerusalem | 91031 | Israel |
| Ramat Gan | 52621 | Israel |
| Tel Aviv | 64239 | Israel |
| Auckland | 1023 | New Zealand |
| Auckland | 1640 | New Zealand |
| Christchurch | 8011 | New Zealand |
| Dunedin | 9054 | New Zealand |
| Takapuna | 0620 | New Zealand |
| Barcelona | Barcelona | 08003 | Spain |
| Barcelona | Barcelona | 08036 | Spain |
| Harrow | HA1 3UJ | United Kingdom |
| London | N6A 4L6 | United Kingdom |
| London | SW10 9NH | United Kingdom |
| Newcastle upon Tyne | NE1 4LP | 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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