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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003409-36 | EudraCT Number |
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This study is an open-label extension (OLE) trial to evaluate the safety and tolerability of etrolizumab in participants with moderate to severe ulcerative colitis (UC) who were enrolled in the Phase II Study ABS4986g (NCT01336465) and meet the eligibility criteria for entry in the OLE study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etrolizumab | Experimental | Etrolizumab 100 milligrams (mg) subcutaneous (SC) administration every 4 weeks during the treatment period of up to 240 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etrolizumab | Drug | Participants will receive etrolizumab at a dose of 100 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) | Baseline up to approximately Week 246 | |
| Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab | Baseline up to approximately Week 246 (assessed at predose (Hour 0) at baseline, Weeks 4, 8, 12, and every 12 weeks thereafter up to Week 252, 12 weeks after last dose [up to approximately Week 246]) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentrations of Etrolizumab | Predose (Hour 0) at baseline, Weeks 4, 8, 12, and every 12 weeks thereafter up to approximately Week 246; 12 weeks after last dose (up to approximately Week 246) |
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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 |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92037 | United States | ||
| Atlanta Gastroenterology Associates |
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| Atlanta |
| Georgia |
| 30342 |
| United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| Long Island Clin Rsch Asc, LLP | Great Neck | New York | 11021 | United States |
| Consultants for Clin. Rsrch | Cincinnati | Ohio | 45219 | United States |
| The Canberra Hospital | Garran | Australian Capital Territory | 2065 | Australia |
| St Vincent's Hospital Melbourne; Department of Gastroenterology | Fitzroy | Victoria | 3065 | Australia |
| Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Royal Melbourne Hospital; Gastroenterology | Parkville | Victoria | 3050 | Australia |
| Imeldaziekenhuis | Bonheiden | 2820 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| GI Research Institute | Vancouver | British Columbia | V6Z 2K5 | Canada |
| London Health Sciences Centre; Victoria Hospital | London | Ontario | N6A 4G5 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 4L6 | Canada |
| Toronto Digest. Disease Asso. | Woodbridge | Ontario | L4L 4Y7 | Canada |
| Poliklinika Iii, Hk; Hepatogatroenterolgy | Hradec Králové | 500 12 | Czechia |
| Oblastni nemocnice Nachod a.s.; Endoskopicke centrum | Náchod | 547 69 | Czechia |
| Fakultni nemocnice Ostrava | Ostrava - Poruba | 708 52 | Czechia |
| Krajska nemocnice Tomase Bati | Zlín | 762 75 | Czechia |
| CAMPUS VIRCHOW-KLINIKUM; Charité Centrum 13; Med. Klinik Abt. Hepatologie u. Gastroenterologie | Berlin | 13353 | Germany |
| Med. Hochschule Hannover; Gastroenterologie | Hanover | 30625 | Germany |
| Universitatsklinikum Schleswig Holstein; Klinik fur Allgemeine Innere Medizin | Kiel | 24105 | Germany |
| Facharzt für Gastroenterologie | Minden | 32423 | Germany |
| Univ klinikum Ulm; Medizin Zentrum Innere Medizin I | Ulm | 89081 | Germany |
| ENDOMEDIX Kft; Gasztroenterológia Budapest | Budapest | 1073 | Hungary |
| Pannónia Klinika Magánorvosi | Budapest | 1136 | Hungary |
| Petz Aladar County Hosp; 1St Dept. of Internal Med. | Győr | 9024 | Hungary |
| Rambam Medical Center | Haifa | 3109601 | Israel |
| Shaare Zedek Medical Center | Jerusalem | 9103102 | Israel |
| Shaare Zedek Medical Ctr; Dept. of Gastroenterology | Jerusalem | 9103102 | Israel |
| The Chaim Sheba Medical Center; Multiple Sclerosis Center | Ramat Gan | 5262100 | Israel |
| Tel Aviv Sourasky Medical Ctr; Gastroenterology Department | Tel Aviv | 6423900 | Israel |
| Middlemore Hospital | Auckland | New Zealand |
| University of Otago, Christchurch | Christchurch | 8011 | New Zealand |
| Dunedin Hospital; Otago District Health Board | Dunedin | 9054 | New Zealand |
| Shakespeare Specialist Group | Takapuna | 0620 | New Zealand |
| Hospital Clinic I Provincial | Barcelona | 08036 | Spain |
| St. Mark's Hospital; Inflammatory Bowel Disease Unit | Harrow | HA1 3UJ | United Kingdom |
| Royal Victoria Infirmary | 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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