An Open-Label Extension and Safety Monitoring Study of Moderate to Severe Ulcerative Colitis Patients Previously Enrolled in Etrolizumab Phase II/III Studies
An Open-Label Extension and Safety Monitoring Study of Moderate to Severe Ulcerative Colitis Patients Previously Enrolled in Etrolizumab Phase II/III Studies
This two-part, part 1: open-label extension (OLE) and part 2: safety monitoring (SM) study will examine the efficacy and safety of continued etrolizumab treatment in moderate to severe ulcerative colitis (UC) participants previously enrolled in etrolizumab Phase II/III studies. Participants with moderate to severe UC who were enrolled in the Phase II OLE study (GA27927 [NCT01461317]) or the Phase III studies (GA28948 [NCT02163759], GA28949 [NCT02171429], GA28950 [NCT02100696], GA29102 [NCT02165215], and GA29103 [NCT02136069]) were included. Participants from the Phase II OLE study or the Phase III studies who are not eligible or willing to receive etrolizumab in the OLE-SM study, and who have completed the 12-week safety follow-up period will be enrolled in Part 2. Part 1 of OLE-SM will continue for up to 9 years after the first participant is enrolled into the study. Following Part 1, participants will enter Part 2 for a period of 92 weeks.
Inclusion Criteria:
Part 1 (Open-label Extension)
- Participants previously enrolled in the Phase II OLE study or Phase III controlled studies who meet the eligibility criteria for open-label etrolizumab for those studies as described in the protocol
Part 2 (Safety Monitoring)
Exclusion Criteria:
Part 1 (Open-label Extension)
Chicago, Illinois 60637, United States
New York, New York 10021, United States
Cincinnati, Ohio 45267, United States
Parkville, Victoria 3050, Australia
Salvador, Estado de Bahia 41110-170, Brazil
Rio de Janeiro, Rio de Janeiro 21941-913, Brazil
Botucatu, São Paulo 18618-970, Brazil
Edmonton, Alberta T6G 2X8, Canada
Halifax, Nova Scotia B3H 1V7, Canada
Greenfield Park, Quebec J4V 2H1, Canada
Kladno, 272 59, Czechia
Ústí nad Labem, 401 13, Czechia
Hanover, 30625, Germany
Heraklio, 711 10, Greece
Budapest, H-1077, Hungary
Hyderabad, Andhra Pradesh 500058, India
Belagavi, Karnataka 590010, India
Manglore, Karnataka 575001, India
Petach Tiqwa, 49100, Israel
Tel Litwinsky, 52621, Israel
Bologna, Emilia-Romagna 40138, Italy
Milan, Lombardy 20162, Italy
Milan, Lombardy, Italy
San Giovanni Rotondo, Lombardy 71013, Italy
R?ga, LV-1002, Latvia
R?ga, LV-1079, Latvia
Vilnius, LT-08661, Lithuania
Kuala Lumpur, FED. Territory of Kuala Lumpur 56000, Malaysia
Monterrey, Nuevo León 64460, Mexico
NL -nijmegen, 6525 GA, Netherlands
Lørenskog, 1478, Norway
?ód?, 90-349, Poland
Cz?stochowa, 42-202, Poland
Warsaw, 02-781, Poland
Wroc?aw, 50-220, Poland
Wroc?aw, 52-210, Poland
Moskva, Adygeya Republic 127015, Russia
Moscow, Moscow Oblast 119333, Russia
Moscow, Moscow Oblast 123154, Russia
Saint Petersburg, Sankt-Peterburg 193163, Russia
Saint Petersburg, Sankt-Peterburg 194044, Russia
Saint Petersburg, Sankt-Peterburg 194354, Russia
Saint Petersburg, Sankt-Peterburg 197022, Russia
Voronezh, Voronez 394036, Russia
Novosibirsk, 630117, Russia
Stavropol, 355018, Russia
Bern, 3012, Switzerland
Kharkiv, Kharkiv Governorate 61037, Ukraine
Kharkiv, Kharkiv Governorate 61058, Ukraine
Kyiv, Kharkiv Governorate 04107, Ukraine
Kyiv, KIEV Governorate 1023, Ukraine
Kyiv, KIEV Governorate 2091, Ukraine
Poltava, 36011, Ukraine