Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies (COTTONWOOD)

September 30, 2024 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1822

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina, X5003DCE
        • Instituto Medico Damic
      • Rosario, Argentina, S2002KDS
        • Hospital Provincial del Centenario
  • Australia
    • New South Wales
      • Bankstown, New South Wales, Australia, 2200
        • Bankstown-Lidcombe Hospital
      • Concord, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
      • Mackay, Queensland, Australia, 4740
        • Mater Adult Hospital
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre
    • Tasmania
      • Launceston, Tasmania, Australia, 7250
        • Launceston General Hospital; Gastroenterology Research
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • Fitzroy, Victoria, Australia, 3065
        • St Vincent's Hospital Melbourne
      • Footscray, Victoria, Australia, 3011
        • Footscray Hospital
      • Malvern, Victoria, Australia, 3144
        • St Frances Xavier Cabrini Hospital
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital
  • Austria
      • Salzburg, Austria, 5020
        • LKH - Universitätsklinikum der PMU Salzburg
      • Wien, Austria, 1090
        • Medizinische Universität Wien
  • Belgium
      • Antwerpen, Belgium, 2018
        • GZA Ziekenhuizen - campus Sint-Vincentius
      • Bonheiden, Belgium, 2820
        • Imeldaziekenhuis
      • Brussel, Belgium, 1090
        • UZ Brussel
      • Brussels, Belgium, 1000
        • CHU St Pierre (St Pierre)
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires Saint-Luc; Pharmacy
      • Gent, Belgium, 9000
        • Uz Gent
      • Herentals, Belgium, 2200
        • AZ Sint Elisabeth Herentals
      • Leuven, Belgium, 3000
        • UZ Leuven; Neurology
      • Roeselare, Belgium, 8800
        • AZ Delta (Campus Rumbeke)
  • Brazil
    • BA
      • Salvador, BA, Brazil, 41110-170
        • Hospital Universitario Prof Edgar Santos-Ufba; Ambulatorio Magalhaes Neto 3Andar- Dermatologia
    • CE
      • Fortaleza, CE, Brazil, 60430-370
        • Hospital Universitário Walter Cantídio - UFC
    • DF
      • Brasilia, DF, Brazil, 70200-730
        • CCBR - Brasilia
    • GO
      • Goiânia, GO, Brazil, 74535-170
        • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
    • MG
      • Belo Horizonte, MG, Brazil, 30110-068
        • Hospital Felicio Rocho
    • PR
      • Curitiba, PR, Brazil, 80430-160
        • Centro Digestivo de Curitiba
    • RJ
      • Rio de Janeiro, RJ, Brazil, 21941-913
        • Hospital Universitário Clementino Fraga Filho - UFRJ
    • RS
      • Porto Alegre, RS, Brazil, 90035-903
        • Hospital das Clinicas - UFRGS
      • Porto Alegre, RS, Brazil, 90160-092
        • Hospital Ernesto Dornelles
      • Porto Alegre, RS, Brazil, 90035-001
        • Hospital Moinhos de Vento
    • SP
      • Botucatu, SP, Brazil, 18618-970
        • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
      • Campinas, SP, Brazil, 13087-567
        • CAEP - Centro Avancado de Estudos e Pesquisas Ltda.
      • Jaú, SP, Brazil, 17210-190
        • CECIP - Centro de Estudos Clínicos do Interior Paulista
      • Santo Andre, SP, Brazil, 09080-000
        • Pesquisare Saúde Sociedade Simples
      • Sao Bernardo Do Campo, SP, Brazil, 09715-090
        • Hospital Estadual Mario Covas
      • Sao Paulo, SP, Brazil, 01308-050
        • Hospital Sírio-Libanês
      • São Paulo, SP, Brazil, 04039-901
        • Hospital do Servidor Público Estadual/HSPE-SP
  • Bulgaria
      • Dupnitsa, Bulgaria, 2600
        • Medical Centre "Asklepii", OOD
      • Pleven, Bulgaria, 5800
        • Medical center Medconsult Pleven OOD
      • Pleven, Bulgaria, 5800
        • DCC Sv. Pantaleymon OOD; II-nd Clinic of Neurology
      • Ruse, Bulgaria, 7002
        • MHAT - Ruse, AD
      • Sliven, Bulgaria, 8800
        • MHAT "Hadzhi Dimitar", OOD
      • Sofia, Bulgaria, 1407
        • "City Clinic UMHAC" EOOD
      • Sofia, Bulgaria, 1431
        • UMHAT "Sv. Ivan Rilski", EAD
      • Sofia, Bulgaria, 1527
        • UMHAT Tsaritsa Yoanna - ISUL, EAD
      • Sofia, Bulgaria, 1680
        • Diagnostic Consultation Center CONVEX EOOD
      • Stara Zagora, Bulgaria, 6000
        • Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
      • Varna, Bulgaria, 9010
        • MHAT 'Sv. Marina', EAD; First Children's Clinic
      • Veliko Tarnovo, Bulgaria, 5000
        • MC Medica Plus
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • University Of Calgary
      • Edmonton, Alberta, Canada, T6G 2X8
        • Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • Pacific Gastroenterology Associates
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Queen Elizabeth II Health Sciences Centre; Gastroenterology Research
    • Ontario
      • Guelph, Ontario, Canada, N1H 3R3
        • Guelph GI & Surgery Clinic
      • London, Ontario, Canada, N6A 5A5
        • University Hospital - London Health Sciences Centre
      • Oshawa, Ontario, Canada, L1H 7K4
        • Taunton Health Centre
      • Toronto, Ontario, Canada, M6H 3M1
        • Toronto Liver Centre
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Toronto Digestive Disease Associates
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Centre de santé et de services sociaux Champlain-Charles-Le Moyne
      • Levis, Quebec, Canada, G6V 3Z1
        • Hotel Dieu de Levis
      • Montreal, Quebec, Canada, H1T 2M4
        • Hôpital Maisonneuve - Rosemont
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal University Hospital
  • Colombia
      • Cali, Colombia
        • RTS - Fundación Valle de Lili
      • Medellin, Colombia, 050025
        • Instituto de Coloproctologia ICO S.A.S.
  • Croatia
      • Osijek, Croatia, 31000
        • Clinical Hospital Centre Osijek
      • Zagreb, Croatia, 10000
        • Clinical Hospital Sveti Duh; Department of Neurology
  • Czechia
      • Brno, Czechia, 636 00
        • Vojenska nemocnice Brno
      • Brno, Czechia, 65691
        • Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika
      • Hradec Kralove, Czechia, 500 05
        • Fakultni Nemocnice Hradec Kralove
      • Hradec Kralove, Czechia, 500 12
        • Hepato-gastroenterologie HK, s.r.o.
      • Kladno, Czechia, 272 59
        • Oblastni nemocnice Kladno, a.s., nemocnice Stredoces. kraje; Endoskopicke centrum
      • Olomouc, Czechia, 779 00
        • PreventaMed, s.r.o.
      • Ostrava, Czechia, 728 80
        • Mestska nemocnice Ostrava
      • Pardubice, Czechia, 532 03
        • Pardubicka krajska nemocnice a.s.
      • Prague, Czechia, 180 01
        • Nemocnice Na Bulovce
      • Praha 7, Czechia, 170 04
        • ISCARE a.s.
      • Usti Nad Labem, Czechia, 401 13
        • Krajska zdravotni, a.s. ? Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni
      • Zlin, Czechia, 76001
        • Krajska nemocnice T. Bati, a.s.
  • Denmark
      • Hellerup, Denmark, 2900
        • Herlev Og Gentofte Hospital
      • København Ø, Denmark, 2100
        • Rigshospitalet; Afdeling for Tarmsvigt og Leversygdomme
      • Ålborg, Denmark, 9000
        • Ålborg Universitets Hospital; Gastromedicinsk
  • Estonia
      • Tallinn, Estonia, 10138
        • East Tallinn Central Hospital
      • Tallinn, Estonia, 10617
        • West Tallinn Central Hospital
      • Tallinn, Estonia, 13419
        • North Estonia Medical Centre Foundation
      • Tallinn, Estonia, 10117
        • OU Innomedica
      • Tartu, Estonia, 51014
        • Tartu University Hospital
  • France
      • Amiens, France, 80054
        • CHU Amiens - Hopital Sud
      • Caen, France, 14033
        • CHU de Caen Hopital Cote de Nacre
      • Chambray les Tours, France, 37170
        • CHU Tours - Hôpital Trousseau
      • Clichy cedex, France, 92110
        • Hôpital Beaujon
      • Lille, France, 59037
        • Hopital Claude Huriez - CHU Lille
      • Montpellier, France, 34295
        • CHU Hopital Saint Eloi
      • Nice, France, 06202
        • CHU Nice - Hopital de l'Archet 2
      • Paris, France, 75475
        • Hôpital Saint-Louis
      • Pessac, France, 33600
        • CHU Bordeaux - Hôpital Haut-Lévêque
      • Pierre-Benite, France, 69495
        • Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie
      • Saint Etienne, France, 42055
        • CHU Saint Etienne - Hôpital Nord
      • Strasbourg, France, 67098
        • Höpital Hautepierre; Pediatrie1
      • Toulouse Cedex 09, France, 31059
        • CHU de Toulouse - Hôpital Rangueil
      • Vandoeuvre-les-nancy, France, 54511
        • Hôpital de Brabois Adultes
  • Germany
      • Berlin, Germany, 14050
        • DRK Kliniken Berlin Westend
      • Berlin, Germany, 10117
        • Charite Universitaetsmedizin Berlin - Campus Charite Mitte
      • Berlin, Germany, 14163
        • Krankenhaus Waldfriede e. V.
      • Berlin, Germany, 12203
        • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
      • Bochum, Germany, 44789
        • Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
      • Erlangen, Germany, 91054
        • Universitaetsklinikum Erlangen
      • Frankfurt, Germany, 60590
        • Klinikum der Johann Wolfgang Goethe-Universitaet
      • Freiburg, Germany, 79106
        • Universitaetsklinikum Freiburg; Urology
      • Halle, Germany, 06120
        • Universitaetsklinikum Halle (Saale)
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf
      • Hamburg, Germany, 20148
        • Hamburgisches Forschungsinstitut fuer CED
      • Hamburg, Germany, 20249
        • Gastroenterologie Eppendorfer Baum
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie
      • Jena, Germany, 07740
        • Universitaetsklinikum Jena; Apotheke des Uniersitätsklinikums Jena
      • Kiel, Germany, 24116
        • Universitaetsklinikum Schleswig-Holstein, Campus Kiel
      • Lueneburg, Germany, 21339
        • Medizinisches Zentrum Klinikum Lueneburg
      • Mannheim, Germany, 68167
        • Klinikum Mannheim GmbH Universitätsklinikum
      • Muenster, Germany, 48149
        • Universitaetsklinikum Muenster
      • Schweinfurt, Germany, 97421
        • Gemeinschaftspraxis Dres. Joachim Mueller und Steffi Appelt
      • Ulm, Germany, 89081
        • Universitaetsklinikum Ulm
  • Greece
      • Heraklio, Greece, 711 10
        • University General Hospital of Heraklion
  • Hong Kong
      • Hong Kong, Hong Kong
        • University of Hong Kong
  • Hungary
      • Balatonfured, Hungary, 8230
        • DRC Gyogyszervizsgalo Kozpont Kft
      • Bekescsaba, Hungary, 5600
        • Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
      • Budapest, Hungary, H-1077
        • Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
      • Budapest, Hungary, 1136
        • Pannónia Klinika Magánorvosi
      • Budapest, Hungary, 1125
        • Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz és Szakrendelo
      • Budapest, Hungary
        • Endomedix Diagnosztikai Kozpont
      • Budapest, Hungary, 1088
        • Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Debrecen, Hungary, 4025
        • Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
      • Eger, Hungary, 3300
        • Markhot Ferenc Oktato Korhaz es Rendelointezet
      • Gyor, Hungary, 9024
        • Petz Aladar Megyei Oktato Korhaz
      • Kistarcsa, Hungary, 2143
        • Pest Megyei Flor Ferenc Korhaz
      • Miskolc, Hungary, 3526
        • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
      • Pecs, Hungary, 7624
        • Pecsi Tudomanyegyetem
      • Szentes, Hungary, 6600
        • Csongrád Megyei Dr. Bugyi István Kórház
      • Székesfehérvár, Hungary, 8000
        • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • India
      • Pune, India, 411011
        • King Edward Memorial Hospital Research Centre
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500058
        • Deccan College of Medical Sciences and Allied Hospitals; Department of Gastroenterology
    • Gujarat
      • Surat, Gujarat, India, 395002
        • Nirmal Hospital
    • Karnataka
      • Belgaum, Karnataka, India, 590010
        • K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
      • Bengaluru, Karnataka, India, 560054
        • M. S. Ramaiah Medical College and Hospital
      • Manglore, Karnataka, India, 575001
        • Kasturba Medical College & Hospital
    • Maharashtra
      • Nagpur, Maharashtra, India, 440012
        • Midas Institute of Gastroenterology
      • Pune, Maharashtra, India, 411001
        • Ruby Hall Clinic
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Dayanand Medical College and Hospital
    • Rajasthan
      • Jaipur, Rajasthan, India, 302001
        • S. R. Kalla Memorial Gastro & General Hospital
  • Israel
      • Haifa, Israel, 3339419
        • Bnai Zion Medical Center; Internal Medicine
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Jerusalem, Israel, 9112001
        • Hadassah University Hospital - Ein Kerem
      • Nazareth, Israel, 1641101
        • Holy Family Hospital
      • Petach Tiqwa, Israel, 49100
        • Rabin Medical Center Beilinson Campus; Gaucher Clinic Genetics Institute
      • Rehovot, Israel, 7610001
        • Kaplan Medical Center
      • Rishon Lezion, Israel, 7505001
        • Assaf Harofeh
      • Tel Hashomer, Israel, 52621
        • Chaim Sheba Medical Center; Pediatrics B North and Pediatric Endocrinology Unit
  • Italy
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh
      • Modena, Emilia-Romagna, Italy, 40124
        • A.O.U. Policlinico di Modena
      • Parma, Emilia-Romagna, Italy, 43126
        • Azienda Ospedaliero Universitaria di Parma
    • Lazio
      • Roma, Lazio, Italy, 151
        • Azienda Ospedaliera San Camillo Forlanini
      • Roma, Lazio, Italy, 00157
        • Ospedale Sandro Pertini
      • Roma, Lazio, Italy, 00133
        • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
      • Rome, Lazio, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    • Lombardia
      • Brescia, Lombardia, Italy, 25124
        • Fondazione Poliambulanza Istituto Ospedaliero
      • Milano, Lombardia, Italy, 20162
        • Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
      • Milano, Lombardia, Italy, 20121
        • Azienda Ospedaliera Fatebenefratelli e Oftalmico
      • Milano, Lombardia, Italy
        • Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
      • Rho, Lombardia, Italy, 20017
        • Ospedale di Circolo; Neuropsichiatria Infantile
      • Rozzano (MI), Lombardia, Italy, 20089
        • Istituto Clinico Humanitas
      • San Donato Milanese (MI), Lombardia, Italy, 20097
        • I.R.C.C.S Policlinico San Donato
      • San Giovanni Rotondo, Lombardia, Italy, 71013
        • IRCCS Ospedale Casa Sollievo della Soffenza; Stru Comp di Gastroenterologia ed Endoscopia digest
    • Piemonte
      • Torino, Piemonte, Italy, 10128
        • Ospedale Mauriziano Umberto I
    • Sicilia
      • Palermo, Sicilia, Italy, 90127
        • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
    • Toscana
      • Florence, Toscana, Italy, 50134
        • Azienda Ospedaliera Universitaria Careggi
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Azienda Ospedaliera di Padova
  • Korea, Republic of
      • Busan, Korea, Republic of, 602-739
        • Pusan National University Hospital
      • Busan, Korea, Republic of, 49201
        • Dong-A University Hospital
      • Daegu, Korea, Republic of, 41404
        • Kyungpook National University Medical Center
      • Daegu, Korea, Republic of, 41944
        • Kyungpook National University Hospital
      • Daegu, Korea, Republic of, 41931
        • Keimyung University Dongsan Medical Center
      • Daegu, Korea, Republic of, 705-717
        • Yeungnam Univ. Hospital
      • Gyeonggi-do, Korea, Republic of, 15355
        • Korea University Ansan Hospital
      • Seongnam, Korea, Republic of, 13520
        • CHA Bundang Medical Centre; CHA university
      • Seongnam-si, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 03181
        • Kangbuk Samsung Hospital
      • Seoul, Korea, Republic of, 5505
        • Asan Medical Center.
      • Suwon, Korea, Republic of, 442-723
        • The Catholic University Of Korea St. Vincent's Hospital
      • Suwon City, Korea, Republic of, 443-721
        • Ajou University Hospital
      • Wonju-si, Korea, Republic of, 26426
        • Yonsei University Wonju Severance Christian Hospital
  • Latvia
      • Daugavpils, Latvia, LV-5401
        • Central Outpatient Clinic
      • R?ga, Latvia, LV-1002
        • Pauls Stradins Clinical University Hospital
      • R?ga, Latvia, LV-1079
        • Digestive Diseases Center "Gastro"
  • Lithuania
      • Kaunas, Lithuania, 50009
        • Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
      • Klaipeda, Lithuania, 92288
        • Klaipeda Seamen's Hospital, Public Institution
      • Vilnius, Lithuania, LT-08661
        • Vilnius University Hospital Santariskiu Clinic, Public Institution; Cardiology
  • Malaysia
      • Kota Bahru, Malaysia, 15586
        • Hospital Raja Perempuan Zainab II; Department of Medicine
    • FED. Territory OF Kuala Lumpur
      • Kuala Lumpur, FED. Territory OF Kuala Lumpur, Malaysia, 56000
        • Pusat Perubatan Universiti Kebangsaan Malaysia
      • Kuala Lumpur, FED. Territory OF Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Center
    • Pahang
      • Kuantan, Pahang, Malaysia, 25100
        • Hospital Tengku Ampuan Afzan
  • Mexico
      • Cuautitlán Izcalli, Mexico, 54769
        • Phylasis Clinicas Research S de RL de CV
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44160
        • Centro Integral en Reumatología S.A. de C.V. (CIRSA)
    • Nuevo LEON
      • Monterrey, Nuevo LEON, Mexico, 64610
        • Centro Regiomontano de Estudios Clínicos Roma S.C.
      • Monterrey, Nuevo LEON, Mexico, 64000
        • Accelerium S. de R.L. de C.V.
      • Monterrey, Nuevo LEON, Mexico, 64460
        • Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Amsterdam UMC Location AMC
      • Amsterdam, Netherlands, 1081 HV
        • Amsterdam UMC Location VUMC
      • NL -nijmegen, Netherlands, 6525 GA
        • Radboudumc
  • New Zealand
      • Auckland, New Zealand
        • Middlemore Hospital
      • Auckland, New Zealand, 0620
        • North Shore Hospital
      • Dunedin, New Zealand
        • Dunedin Hospital
      • Hamilton, New Zealand, 3248
        • Waikato Hospital
      • Takapuna, New Zealand, 0620
        • Shakespeare Specialist Group
      • Tauranga, New Zealand, 3143
        • Tauranga Hospital
  • Norway
      • Lørenskog, Norway, 1478
        • Akershus Universitetssykehus HF
  • Poland
      • ?ód?, Poland, 90-349
        • AppleTreeClinics Sp. z o.o.
      • Bydgoszcz, Poland, 85-312
        • Nasz Lekarz Osrodek Badan Klinicznych
      • Chojnice, Poland, 89-600
        • Centrum Medyczne Lukamed Joanna Luka
      • Cz?stochowa, Poland, 42-202
        • Centrum Medyczne Sw. Lukasza
      • Gdansk, Poland, 80-305
        • 7 Szpital Marynarki Wojennej z Przychodnia SPZOZ im. W. Lasinskiego
      • Katowice, Poland, 40-645
        • Pro Familia Altera Sp z o.o.
      • Katowice, Poland, 40-660
        • Nzoz All-Medicus
      • Katowice, Poland, 40-752
        • Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego SUM
      • Krakow, Poland, 31-637
        • Nzoz Centrum Medyczne Promimed
      • Ksawerow, Poland, 95-054
        • Centrum Opieki Zdrowotnej Orkan-med
      • Lublin, Poland, 20-582
        • GASTROMED Sp. z o.o.
      • Lublin, Poland, 20-015
        • Indywidualna Specjalistyczna Praktyka Lekarska
      • Nowy Targ, Poland, 34-400
        • Allmedica Badania Kliniczne Sp z o.o. Sp K.
      • Olsztyn, Poland, 10-561
        • Wojewodzki Specjalistyczny Szpital w Olsztynie
      • Pozna?, Poland, 60-529
        • SOLUMED Centrum Medyczne
      • Rzeszow, Poland, 35-055
        • Centrum Medyczne Medyk
      • Rzeszów, Poland, 35-302
        • Gabinet Lekarski, Bartosz Korczowski
      • Sopot, Poland, 81-756
        • Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia
      • Szczecin, Poland, 71-434
        • Twoja Przychodnia-Szczecinskie Centrum Medyczne
      • Szczecin, Poland, 70-351
        • Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
      • Warszawa, Poland, 03-580
        • NZOZ Vivamed
      • Warszawa, Poland, 02-018
        • Zespó Przychodni Specjalistycznych PRIMA
      • Warszawa, Poland, 02-653
        • Endoterapia PFG Sp. z o.o.
      • Warszawa, Poland, 02-781
        • Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy
      • Warszawa, Poland, 00-189
        • Centrum Zdrowia MDM
      • Wroc?aw, Poland, 50-220
        • Przychodnia EuroMediCare
      • Wroc?aw, Poland, 52-210
        • Planetmed
      • Wroclaw, Poland, 53-114
        • LexMedica Osrodek Badan Klinicznych
  • Portugal
      • Braga, Portugal, 4710-243
        • Hospital de Braga
      • Guimarães, Portugal, 4835-044
        • Hospital Da Senhora Da Oliveira Guimarăes
  • Romania
      • Bucharest, Romania, 772202
        • Spitalul Clinic Colentina
      • Bucuresti, Romania, 010719
        • S.C MedLife S.A
      • Bucuresti, Romania, 040055
        • Centrul Medical Unirea SRL
      • Timisoara, Romania, 300002
        • Centrul de Gastroenterologie Dr. Goldis
  • Russian Federation
      • Irkutsk, Russian Federation, 664079
        • Irkutsk State Medical Academy of Continuing Education
      • Novosibirsk, Russian Federation, 630117
        • FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS
      • Omsk, Russian Federation, 644013
        • BHI of Omsk region Clinical Oncology Dispensary
      • Omsk, Russian Federation, 644043
        • SBEI of HPE "Omsk SMA" Ministry of healthcare of RF"
      • Stavropol, Russian Federation, 355017
        • Stavropol Regional Clinical Diagnostic Consultative Center
      • Stavropol, Russian Federation, 355018
        • FSBEI HE "Stavropol State Medical University" of Ministry of Healthcare of Russian Federation
    • Adygeja
      • Moskva, Adygeja, Russian Federation, 127015
        • Yusupov Hospital
    • Altaj
      • Barnaul, Altaj, Russian Federation, 656050
        • SBEI HPE Altai StateMedicalUniversityofMoH andSD
    • Leningrad
      • St.Petersburg, Leningrad, Russian Federation, 194356
        • Baltic Medicine
    • Moskovskaja Oblast
      • Moscow, Moskovskaja Oblast, Russian Federation, 119333
        • FSBIH Central Clinical Hospital of RAS
      • Moscow, Moskovskaja Oblast, Russian Federation, 123154
        • FSBI ?State Scientific Centre of Coloproctology" of the MoH of RF; Gastroenterology
    • Niznij Novgorod
      • Nizhny Novgorod, Niznij Novgorod, Russian Federation, 603126
        • SBHI of NN region ?RCH of NN n.a. N.A.Semashko?
    • Rostov
      • Rostov-on-Don, Rostov, Russian Federation, 344022
        • SEIHPE "Rostov SMU of MoH of RF"
    • Sankt Petersburg
      • Sankt-peterburg, Sankt Petersburg, Russian Federation, 197110
        • SBIH City Clinical Hospital #31
      • Sankt-peterburg, Sankt Petersburg, Russian Federation, 194044
        • FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine"; Pulmonology
      • Sankt-peterburg, Sankt Petersburg, Russian Federation, 194354
        • SPb SBIH "City Multy-field Hospital # 2"; Intensive Pulmonology and Thoracal Surgery
      • St Petersburg, Sankt Petersburg, Russian Federation, 196247
        • City Hospital #26
      • St-petersburg, Sankt Petersburg, Russian Federation, 198035
        • LLC International Medical Centre ?SOGAZ?
      • St. Petersburg, Sankt Petersburg, Russian Federation, 193163
        • FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF; Therapy
      • St. Petersburg, Sankt Petersburg, Russian Federation, 197022
        • Pavlov First Saint Petersburg State Medical University
      • St. Petersburg, Sankt Petersburg, Russian Federation, 197110
        • SPb SHI "City Hospital #9"
    • Vologda
      • Cherepovets, Vologda, Russian Federation, 162600
        • Medical and Sanitary Division of Severstal
    • Voronez
      • Voronezh, Voronez, Russian Federation, 394036
        • SBEI HPE "Voronezh State Medical University n.a. N.N. Burdenko" of the MoH of the RF
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Center Zvezdara
      • Belgrade, Serbia, 11080
        • Clinical Center Zemun
      • Belgrade, Serbia, 11040
        • Military Medical Academy
      • Kragujevac, Serbia, 34000
        • Clinical center Kragujevac
      • Zrenjanin, Serbia, 23000
        • General Hospital Djordje Joanovic
  • Singapore
      • Singapore, Singapore, 169608
        • Singapore General Hospital
  • Slovakia
      • Banska Bystrica, Slovakia, 974 01
        • Fakultna nemocnica s poliklinikou F.D. Roosevelta
      • Humenné, Slovakia, 066 01
        • Nemocnica A.Lena Humenne, n.o.
      • Košice, Slovakia, 040 01
        • ENDOMED, s.r.o.
      • Nitra, Slovakia, 94901
        • KM Management spol. s r.o.
      • Prešov, Slovakia, 080 01
        • Gastro I, s.r.o.
      • Rimavská Sobota, Slovakia, 979 01
        • Svet zdravia a.s.
      • Šahy, Slovakia, 936 01
        • Accout Center s.r.o.
  • South Africa
      • Bloemfontein, South Africa, 9301
        • Netcare Universitas Private Hospital
      • Cape Town, South Africa, 7500
        • Dr MJ Prins Practice
      • Cape Town, South Africa, 7708
        • Dr JP Wright Practice
      • Pretoria, South Africa, 0002
        • Emmed Research
  • Spain
      • Barcelona, Spain
        • Centro Médico Teknon
      • Girona, Spain, 17007
        • Hospital Universitari de Girona Dr Josep Trueta
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28006
        • Hospital Universitario de la Princesa
      • Madrid, Spain, 28942
        • Hospital Universitario de Fuenlabrada
      • Valencia, Spain, 46026
        • Hospital Universitari I Politècnic La Fe
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Sanitaria Parc Tauli
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • Fundacion Hospital de Alcorcon; Servicio de Digestivo
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital-Universitaetsspital Bern
      • Bern, Switzerland, 3012
        • Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner
  • Turkey
      • Ankara, Turkey, 06500
        • Gazi University Medical Faculty; Gastroenterology
      • Istanbul, Turkey, 34668
        • Haydarpasa Numune Training and Research Hospital; Medical Oncology
      • Kocaeli, Turkey, 41380
        • Kocaeli Universitesi Tip Fakultesi; Infectious Diseases
  • Ukraine
      • Chernivtsi, Ukraine, 58002
        • RCI Chernivtsi RCH Gastroenterology Bukovinsky SMU
      • Dnipropetrovsk, Ukraine, 49074
        • SI Dnipropetrovsk MA of MOHU SI Institute of gastroenterology of AMSU
      • Kharkiv, Ukraine, 61039
        • GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
      • Kharkiv, Ukraine, 61124
        • CI of Healthcare Kharkiv CCH #13
      • Kherson, Ukraine, 73000
        • CI Kherson Afanasii and Olha Tropiny City Clinical Hospital
      • Kyiv, Ukraine, 02232
        • CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv
      • Odessa, Ukraine, 65117
        • Odessa regional clinical Hospital
      • Poltava, Ukraine, 36011
        • M.V. Sklifosovskyi Poltava RCH Outpatient UMSA HSEIU Ukrainian Medical Stomatological Academy
      • Poltava, Ukraine, 36011
        • M.V. Sklifosovskyi Poltava RCH Dept of Gastroenterology HSEIU UMSA
      • Vinnytsia, Ukraine, 21018
        • M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
      • Vinnytsia, Ukraine, 21001
        • Private Small Enterprise Medical Center Pulse
      • Vinnytsia, Ukraine, 21029
        • MCIC Health Clinic BO LTD TPC Slaomed
      • Zaporizhzhia, Ukraine, 69118
        • CI City Hospital #7
      • Zaporizhzhia, Ukraine, 69035
        • Co Ltd. Diaservice
    • KIEV Governorate
      • Kyiv, KIEV Governorate, Ukraine, 1023
        • Medical Center of Limited Liability Company Medical Clinic Blagomed
      • Kyiv, KIEV Governorate, Ukraine, 2091
        • Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
      • Kyiv, KIEV Governorate, Ukraine, 4073
        • CI of Kyiv RC Regional Clinical Hospital #2
      • Kyiv, KIEV Governorate, Ukraine, 04107
        • CI of Kyiv RC Kyiv Regional Clinical Hospital
      • Kyiv, KIEV Governorate, Ukraine, 01030
        • CNE Kyiv CCH #18
      • Lviv, KIEV Governorate, Ukraine, 79010
        • Lviv Regional Clinical Hospital
      • Uzhgorod, KIEV Governorate, Ukraine, 88018
        • A.Novak Transcarpathian Regional Clinical Hospital
      • Uzhgorod, KIEV Governorate, Ukraine, 88009
        • CI UDH Dept of Ther SHEI Fac of PGE&Pre-Univ Training
    • Kharkiv Governorate
      • Kharkiv, Kharkiv Governorate, Ukraine, 61037
        • CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
      • Kharkiv, Kharkiv Governorate, Ukraine, 61058
        • Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital
      • Kyiv, Kharkiv Governorate, Ukraine, 04107
        • Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
      • Sumy, Kharkiv Governorate, Ukraine, 40022
        • CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI
      • Zaporizhzhia, Kharkiv Governorate, Ukraine, 69000
        • LLC Gastroenterology Center IBD Team
    • Podolia Governorate
      • Chernivtsi, Podolia Governorate, Ukraine, 58002
        • RCNECRCH Dept of Surgery, SHEI Ukr BSMU
    • Tavria Okruha
      • Zaporizhzhia, Tavria Okruha, Ukraine, 69104
        • CI City Hospital #1
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrooke's Hospital
      • Coventry, United Kingdom, CV2 2DX
        • University Hospital Coventry
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Hospital (Wonford)
      • Leeds, United Kingdom, LS9 7TF
        • St James University Hospital
      • London, United Kingdom, E1 1FR
        • The Royal London Hospital
      • London, United Kingdom, N7 9NH
        • University College London Hospital
      • London, United Kingdom, SE5 9NU
        • King's College London
      • London, United Kingdom, SE1 7EH
        • St Thomas Hospital
      • Manchester, United Kingdom, M8 5RB
        • Fairfield General Hospital
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Royal Victoria Infirmary
      • Nottingham, United Kingdom, NG7 2UH
        • Nottingham University Hospitals; QMC Campus
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama Medical Center
    • California
      • La Jolla, California, United States, 92093-5354
        • University of California San Diego Medical Center
      • Orange, California, United States, 92868
        • University of California, Irvine Medical Center
      • San Diego, California, United States, 92103
        • SDG Clinical Research
      • San Francisco, California, United States, 94115
        • University of California at San Francisco
      • Ventura, California, United States, 93003
        • Ventura Clinical Trials
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Peak Gastroenterology Associates
      • Lafayette, Colorado, United States, 80026
        • Clinical Research of the Rockies
      • Wheat Ridge, Colorado, United States, 80033
        • Rocky Mountain Gastroenterology Associates
    • Florida
      • Aventura, Florida, United States, 33180
        • Innovative Medical Research of South Florida, Inc.
      • Clearwater, Florida, United States, 33756
        • West Central Gastroenterology d/b/a Gastro Florida
      • Miami, Florida, United States, 33155
        • Regenerate Clinical Trials
      • Miami Beach, Florida, United States, 33140
        • IMIC, Inc
      • Miramar, Florida, United States, 33025
        • FQL Research, LLC
      • Naples, Florida, United States, 34102
        • Gastroenterology Group Of Naples
      • New Port Richey, Florida, United States, 34653
        • Advanced Research Institute, Inc.
      • Orlando, Florida, United States, 32806
        • Internal Medicine Specialists
      • Winter Park, Florida, United States, 32789
        • Shafran Gastroenterology Center
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Atlanta Gastroenterology Associates
      • Macon, Georgia, United States, 31201
        • Gastroenterology Associates of Central Georgia
      • Marietta, Georgia, United States, 30060
        • Gastrointestinal Specialists of Georgia, PC
      • Suwanee, Georgia, United States, 30024
        • Atlanta Gastroenterology Specialists, PC
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School Of Medicine
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center; Medicine, Section of Pulmonary
      • Oak Lawn, Illinois, United States, 60453
        • Southwest Gastroenterology
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Aquiant Research
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton-O'Neil Clinical Research Center, Digestive Health
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Gastroenterology Associates, LLC
      • Shreveport, Louisiana, United States
        • Louisiana Research Center, LLC
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital; Crohn's & Colitis Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Troy, Michigan, United States, 48098
        • Center for Digestive Health
      • Ypsilanti, Michigan, United States, 48197
        • Huron Gastroenterology Associates
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Regents of the University of Minnesota
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Belton, Missouri, United States, 64012
        • Ehrhardt Clinical Research, LLC
      • Kansas City, Missouri, United States, 64131
        • Kansas City Research Institute, LLC
    • New York
      • Great Neck, New York, United States, 11021
        • Clinica Peruano Americana S.A.
      • New York, New York, United States, 10021
        • Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
      • New York, New York, United States, 10016-9451
        • NYU Langone Medical Center
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Asheville Gastroenterology Associates, P.A.
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
      • Kinston, North Carolina, United States, 28501
        • Kinston Medical Specialists
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Consultants for Clin. Rsrch
      • Cincinnati, Ohio, United States, 45267
        • UC Health Clinical Trials Office; Division of Digestive Diseases
      • Mentor, Ohio, United States, 44060
        • Great Lakes Gastroenterology Research, LLC
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Gastroenterology Center of the Midsouth, P.C.
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75231
        • Texas Digestive Disease Consultants - Dallas
      • San Antonio, Texas, United States, 78232
        • Wellness Clinical Research Center
      • Southlake, Texas, United States, 76092
        • Texas Digestive Disease Consultants - Southlake
      • Tyler, Texas, United States, 75701
        • Tyler Research Institute, LLC
    • Utah
      • Clinton, Utah, United States, 84015
        • Ericksen Research and Development
      • Salt Lake City, Utah, United States, 84132
        • University of Utah School of Medicine
    • Virginia
      • Richmond, Virginia, United States, 23249
        • McGuire Research Institute; Gastroenterology
    • Washington
      • Bellevue, Washington, United States, 98004
        • Washington Gastroenterology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

  • Participants whose safety follow-up or PML follow-up is not completed within Study GA27927 and participants who had their last dose of etrolizumab in July 2016 in Study GA27927 and are not eligible or willing to enroll in Part 1 (OLE)
  • Participants who participated in one of the etrolizumab Phase III studies and are not eligible or willing to enter Part 1 (OLE)
  • Participants who transfer from Part 1 (OLE)
  • Completion of the 12-week safety follow-up prior to entering.

Exclusion Criteria:

Part 1 (Open-label Extension)

  • Withdrawal of consent from and participant not compliant in the Phase II OLE study or any of the Phase III studies
  • Participant who discontinued etrolizumab/etrolizumab placebo prior to Week 10 or did not perform the Week 10 visit of the Phase III Studies GA28948, GA28949, GA29102, and GA29103
  • Participant who discontinued etrolizumab/etrolizumab placebo prior to Week 14 or did not perform the Week 14 visit of the Phase III Study GA28950
  • Any new, significant, uncontrolled condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: Open-label Extension
Participants with moderate to severe UC who were enrolled in the Phase II OLE study or the Phase III studies, and who meet the eligibility criteria for enrollment will receive open-label etrolizumab in Part 1 (OLE).
Drug: Etrolizumab
Participants will receive etrolizumab 105 milligrams (mg), administered subcutaneously (SC) every 4 weeks for up to 9 years or until either commercial availability or the Sponsor's decision to terminate the study.
Other Names:
  • RO5490261
  • RG7413
  • PRO145223
  • rhuMAb Beta7
No Intervention: Part 2: Safety Monitoring
All participants from Part 1 (OLE), participants whose PML follow-up is not completed within the Phase II OLE study, and participants transferring from the Phase III double-blind studies after the 12-week safety follow-up will be monitored for PML (92 weeks).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS)
Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324 weeks
The pMCS is a composite of 3 assessments, each rated from 0 (none) to 3 (severe disease): stool frequency, rectal bleeding, and physician's global assessment. The total score for pMCS ranges from 0 (none) to 9 (severe disease). pMCS clinical remission was defined as pMCS ≤ 2, a rectal bleeding score of 0-1, physician's global assessment of 0-1, stool frequency subscore of 0-1. Percentages have been rounded off.
Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324 weeks
Part 1: Percentage of Participants With Remission as Determined by the Mayo Clinic Score (MCS)
Time Frame: At OLE Week 108
The Mayo Clinic scoring system is a composite of 4 assessments for UC disease activity. The 4 component sub-scores are: 1) stool frequency, 2) rectal bleeding, 3) flexible sigmoidoscopy scores, and 4) physician's global assessment, each rated from 0-3, 0 representing no pathology to 3 for severe disease. The minimum Mayo Score is 0 (no pathology) and the maximum is 12 (severe disease). MCS remission was defined as MCS ≤ 2, a rectal bleeding score of 0, physician's global assessment of 0-1, stool frequency subscore of 0-1 and endoscopy score of 0-1. Percentage has been rounded off.
At OLE Week 108
Part 1: Percentage of Participants With Endoscopic Remission
Time Frame: At OLE Week 108
The Mayo scoring system is a composite of 4 assessments for UC disease activity. The 4 component sub-scores are: 1) stool frequency, 2) rectal bleeding, 3) flexible sigmoidoscopy scores, and 4) physician's global assessment, each rated from 0-3, 0 representing no pathology to 3 for severe disease. The minimum Mayo Score is 0 (no pathology) and the maximum is 12 (severe disease). Endoscopic remission was defined as Mayo Endoscopic subscore = 0. Percentage has been rounded off.
At OLE Week 108
Part 1: Number of Participants With Adverse Events (AEs) and Severity of AEs Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [NCI CTCAE v4.0]
Time Frame: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
An AE is any untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. AEs were graded as per NCI CTCAE v4.0. Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4=Life-threatening consequences/urgent intervention indicated; Grade 5=Death related to adverse event.
From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
Part 1: Number of Participants With Serious Adverse Events (SAEs)
Time Frame: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigation, whether or not considered related to the medicinal (investigational) product. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
Part 1: Number of Participants With Infection Related AEs and Severity of Infection-Related AEs Assessed Using NCI CTCAE v4.0
Time Frame: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
An AE is any untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. AEs were graded as per NCI CTCAE v4.0. Grade 1= Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4=Life-threatening consequences/urgent intervention indicated; Grade 5=Death related to adverse event.
From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
Part 1: Number of Participants With Serious Infection Related AES
Time Frame: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
Part 1: Number of Participants With Injection Site Reactions and Severity of Injection Site Reactions Assessed Using NCI CTCAE v4.0
Time Frame: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
AE=untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. Injection-site reaction=any local reaction occurring at the site of injection following study drug administration. Signs (e.g., erythema, induration/swelling at injection site) and symptoms (e.g., pain, pruritus at injection site). Injection site reactions. were graded as per NCI CTCAE v4.0. Grade 1=Tenderness with or without associated symptoms (e.g., warmth, erythema, itching); Grade 2=Pain; lipodystrophy; edema; phlebitis; Grade 3=Ulceration or necrosis; severe tissue damage; operative intervention indicated; Grade 4=life-threatening consequences or urgent intervention indicated; Grade=5 death related to AE.
From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
Part 1: Number of Participants With AEs Leading to Etrolizumab Discontinuation
Time Frame: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a Etrolizumab, whether or not considered related to the medicinal (investigational) product. Number of participants who discontinued etrolizumab treatment during the OLE period have been reported here.
From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
Part 1: Number of Participants With Malignancies
Time Frame: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Number of participants who developed malignancies during the OLE period have been reported here.
From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
Part 1: Number of Participants With Hypersensitivity Reactions and Severity of Hypersensitivity Assessed Using NCI-CTCAE v4.0
Time Frame: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
AE=untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. Hypersensitivity was assessed as per NCI CTCAE v4.0. Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living.
From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)
Part 2: Number of Participants With Confirmed Progressive Multifocal Leukoencephalopathy (PML) During the Post-Treatment PML Monitoring Period
Time Frame: From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks
From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2014

Primary Completion (Actual)

October 5, 2023

Study Completion (Actual)

October 5, 2023

Study Registration Dates

First Submitted

April 16, 2014

First Submitted That Met QC Criteria

April 16, 2014

First Posted (Estimated)

April 21, 2014

Study Record Updates

Last Update Posted (Actual)

October 23, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GA28951
  • 2013-004435-72 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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