Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies (COTTONWOOD)
Ulcerative Colitis
About this trial
This is an interventional treatment trial for Ulcerative Colitis
Eligibility Criteria
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
Sites / Locations
- University of Alabama Medical Center
- University of California San Diego Medical Center
- University of California, Irvine Medical Center
- SDG Clinical Research
- University of California at San Francisco
- Ventura Clinical Trials
- Peak Gastroenterology Associates
- Clinical Research of the Rockies
- Rocky Mountain Gastroenterology Associates
- Innovative Medical Research of South Florida, Inc.
- West Central Gastroenterology d/b/a Gastro Florida
- IMIC, Inc
- Regenerate Clinical Trials
- FQL Research, LLC
- Gastroenterology Group of Naples
- Advanced Research Institute, Inc.
- Internal Medicine Specialists
- Shafran Gastroenterology Center
- Atlanta Gastroenterology Associates
- Gastroenterology Associates of Central Georgia
- Gastrointestinal Specialists of Georgia, PC
- Atlanta Gastroenterology Specialists, PC
- Northwestern University Feinberg School Of Medicine
- University of Chicago Medical Center; Medicine, Section of Pulmonary
- Southwest Gastroenterology
- Aquiant Research
- Cotton-O'Neil Clinical Research Center, Digestive Health
- Gastroenterology Associates, LLC
- Louisiana Research Center, LLC
- Massachusetts General Hospital; Crohn's & Colitis Center
- University of Michigan
- Henry Ford Health System
- Center for Digestive Health
- Huron Gastroenterology Associates
- Regents of the University of Minnesota
- University of Mississippi Medical Center
- Ehrhardt Clinical Research, LLC
- Kansas City Research Institute, LLC
- Clinica Peruano Americana S.A.
- NYU Langone Medical Center
- Concorde Medical Group
- Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
- Asheville Gastroenterology Associates, P.A.
- University of North Carolina at Chapel Hill
- Kinston Medical Specialists
- Consultants for Clin. Rsrch
- UC Health Clinical Trials Office; Division of Digestive Diseases
- Great Lakes Gastroenterology Research, LLC
- Gastroenterology Center of the Midsouth, P.C.
- Vanderbilt University Medical Center
- Texas Digestive Disease Consultants - Dallas
- Wellness Clinical Research Center
- Texas Digestive Disease Consultants - Southlake
- Tyler Research Institute, LLC
- Ericksen Research and Development
- University of Utah School of Medicine
- McGuire Research Institute; Gastroenterology
- Washington Gastroenterology
- Instituto Medico DAMIC
- Hospital Provincial del Centenario
- Bankstown-Lidcombe Hospital
- Concord Repatriation General Hospital
- Royal Brisbane and Women's Hospital
- Mater Adult Hospital
- Princess Alexandra Hospital
- Royal Adelaide Hospital
- Flinders Medical Centre
- Launceston General Hospital; Gastroenterology Research
- Monash Medical Centre
- St Vincent's Hospital Melbourne
- Footscray Hospital
- St Frances Xavier Cabrini Hospital
- Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics
- Fiona Stanley Hospital
- LKH - Universitätsklinikum der PMU Salzburg
- Medizinische Universität Wien
- GZA Ziekenhuizen - Campus Sint-Vincentius
- Imeldaziekenhuis
- CHU St Pierre (St Pierre)
- UZ Brussel
- Cliniques Universitaires Saint-Luc; Pharmacy
- UZ Gent
- AZ Sint Elisabeth Herentals
- UZ Leuven; Neurology
- AZ Delta (Campus Rumbeke)
- Hospital Universitario Prof Edgar Santos-Ufba; Ambulatorio Magalhaes Neto 3Andar- Dermatologia
- Hospital Universitario Walter Cantidio - UFC
- CCBR - Brasilia
- Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
- Hospital Felicio Rocho
- Centro Digestivo de Curitiba
- Hospital Universitario Clementino Fraga Filho - UFRJ
- Hospital Moinhos de Vento
- Hospital das Clinicas - UFRGS
- Hospital Ernesto Dornelles
- UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
- CAEP - Centro Avancado de Estudos e Pesquisas Ltda.
- CECIP - Centro de Estudos Clínicos do Interior Paulista
- Pesquisare Saúde Sociedade Simples
- Hospital Estadual Mario Covas
- Hospital Sírio-Libanês
- Hospital do Servidor Público Estadual/HSPE-SP
- Medical Centre "Asklepii", OOD
- DCC Sv. Pantaleymon OOD; II-nd Clinic of Neurology
- Medical center Medconsult Pleven OOD
- MHAT - Ruse, AD
- MHAT "Hadzhi Dimitar", OOD
- "City Clinic UMHAC" EOOD
- UMHAT "Sv. Ivan Rilski", EAD
- UMHAT Tsaritsa Yoanna - ISUL, EAD
- Diagnostic Consultation Center CONVEX EOOD
- Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
- MHAT 'Sv. Marina', EAD; First Children's Clinic
- MC Medica Plus
- University of Calgary
- Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology
- Pacific Gastroenterology Associates
- Queen Elizabeth II Health Sciences Centre; Gastroenterology Research
- Guelph GI & Surgery Clinic
- University Hospital - London Health Sciences Centre
- Taunton Health Centre
- Mount Sinai Hospital
- Toronto Liver Centre
- Toronto Digestive Disease Associates
- Centre de santé et de services sociaux Champlain-Charles-Le Moyne
- Hotel Dieu de Levis
- Hôpital Maisonneuve - Rosemont
- Royal University Hospital
- RTS - Fundación Valle de Lili
- Instituto de Coloproctologia ICO S.A.S.
- Clinical Hospital Centre Osijek
- Clinical Hospital Sveti Duh; Department of Neurology
- Vojenska nemocnice Brno
- Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika
- Fakultni nemocnice Hradec Kralove
- Hepato-Gastroenterologie HK, s.r.o.
- Oblastni nemocnice Kladno, a.s., nemocnice Stredoces. kraje; Endoskopicke centrum
- PreventaMed, s.r.o.
- Mestska Nemocnice Ostrava
- Pardubicka krajska nemocnice a.s.
- Nemocnice Na Bulovce
- ISCARE a.s.
- Krajska zdravotni, a.s. ? Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni
- Krajska nemocnice T. Bati, a.s.
- Herlev og Gentofte Hospital
- Rigshospitalet; Medicinsk gastroenterologisk klinik
- Ålborg Universitets Hospital; Gastromedicinsk
- OÜ Innomedica
- East Tallinn Central Hospital
- West Tallinn Central Hospital
- North Estonia Medical Centre Foundation
- Tartu University Hospital
- CHU Amiens - Hopital Sud
- CHU de Caen Hopital Cote de Nacre
- CHU Tours - Hôpital Trousseau
- Hôpital Beaujon
- Hopital Claude Huriez - CHU Lille
- CHU Hopital Saint Eloi
- CHU Nice - Hopital de l'Archet 2
- Hôpital Saint-Louis
- CHU Bordeaux - Hôpital Haut-Lévêque
- Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie
- CHU Saint Etienne - Hôpital Nord
- Höpital Hautepierre; Pediatrie1
- CHU de Toulouse - Hôpital Rangueil
- Hôpital de Brabois Adultes
- Charite Universitaetsmedizin Berlin - Campus Charite Mitte
- Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
- DRK Kliniken Berlin Westend
- Krankenhaus Waldfriede e. V.
- Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
- Universitaetsklinikum Erlangen
- Klinikum der Johann Wolfgang Goethe-Universitaet
- Universitaetsklinikum Freiburg; Urology
- Universitaetsklinikum Halle (Saale)
- Hamburgisches Forschungsinstitut fuer CED
- Universitätsklinikum Hamburg-Eppendorf
- Gastroenterologie Eppendorfer Baum
- Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie
- Universitaetsklinikum Jena; Apotheke des Uniersitätsklinikums Jena
- Universitaetsklinikum Schleswig-Holstein, Campus Kiel
- Medizinisches Zentrum Klinikum Lueneburg
- Klinikum Mannheim GmbH Universitätsklinikum
- Universitaetsklinikum Muenster
- Gemeinschaftspraxis Dres. Joachim Mueller und Steffi Appelt
- Universitaetsklinikum Ulm
- University General Hospital of Heraklion
- University of Hong Kong
- DRC Gyogyszervizsgalo Kozpont Kft
- Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
- Semmelweis Egyetem
- Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo
- Pannónia Klinika Magánorvosi
- Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
- Endomedix Diagnosztikai Kozpont
- Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
- Debreceni Egyetem Klinikai Kozpont
- Markhot Ferenc Oktato Korhaz es Rendelointezet
- Petz Aladar Megyei Oktato Korhaz
- Pest Megyei Flor Ferenc Korhaz
- Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
- Pecsi Tudomanyegyetem
- Csongrad Megyei Dr. Bugyi Istvan Korhaz
- Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
- Deccan College of Medical Sciences and Allied Hospitals; Department of Gastroenterology
- Nirmal Hospital
- K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
- M. S. Ramaiah Medical College and Hospital
- Kasturba Medical College & Hospital
- Midas institute of Gastroenterology
- Ruby Hall Clinic
- Dayanand Medical College and Hospital
- S. R. Kalla Memorial Gastro & General Hospital
- King Edward Memorial Hospital Research Centre
- Bnai Zion Medical Center; Internal Medicine
- Shaare Zedek Medical Center
- Hadassah University Hospital - Ein Kerem
- Holy Family Hospital
- Rabin Medical Center Beilinson Campus; Gaucher Clinic Genetics Institute
- Kaplan Medical Center
- Assaf Harofeh
- Chaim Sheba Medical Center; Pediatrics B North and Pediatric Endocrinology Unit
- Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh
- A.O.U. Policlinico di Modena
- Azienda Ospedaliero Universitaria di Parma
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata
- Ospedale Sandro Pertini
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Azienda Ospedaliera San Camillo Forlanini
- Azienda Ospedaliero Universitaria San Martino
- Fondazione Poliambulanza Istituto Ospedaliero
- Azienda Ospedaliera Fatebenefratelli e Oftalmico
- Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
- Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
- Ospedale di Circolo; Neuropsichiatria Infantile
- Istituto Clinico Humanitas
- I.R.C.C.S Policlinico San Donato
- IRCCS Ospedale Casa Sollievo della Soffenza; Stru Comp di Gastroenterologia ed Endoscopia digest
- Ospedale Mauriziano Umberto I
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
- Azienda Ospedaliera Universitaria Careggi
- Azienda Ospedaliera di Padova
- Dong-A University Hospital
- Pusan National University Hospital
- Kyungpook National University Medical Center
- Keimyung University Dongsan Medical Center
- Kyungpook National University Hospital
- Yeungnam Univ. Hospital
- Korea University Ansan Hospital
- Seoul National University Bundang Hospital
- CHA Bundang Medical Centre; CHA university
- Seoul National University Hospital
- Kangbuk Samsung Hospital
- Severance Hospital, Yonsei University Health System
- Samsung Medical Center
- Asan Medical Center.
- Ajou University Hospital
- The Catholic University of Korea St. Vincent's Hospital
- Yonsei University Wonju Severance Christian Hospital
- Central Outpatient Clinic
- Pauls Stradins Clinical University Hospital
- Digestive Diseases Center "Gastro"
- Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
- Klaipeda Seamen's Hospital, Public Institution
- Vilnius University Hospital Santariskiu Clinic, Public Institution; Cardiology
- Pusat Perubatan Universiti Kebangsaan Malaysia
- University Malaya Medical Center
- Hospital Tengku Ampuan Afzan
- Hospital Raja Perempuan Zainab II; Department of Medicine
- Centro Integral en Reumatología S.A. de C.V. (CIRSA)
- Accelerium S. de R.L. de C.V.
- Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León
- Centro Regiomontano de Estudios Clínicos Roma S.C.
- Phylasis Clinicas Research S de RL de CV
- Amsterdam UMC Location VUMC
- Amsterdam UMC Location AMC
- Radboudumc
- North Shore Hospital
- Middlemore Hospital
- Dunedin Hospital
- Waikato Hospital
- Shakespeare Specialist Group
- Tauranga Hospital
- Akershus universitetssykehus HF
- AppleTreeClinics Sp. z o.o.
- Nasz Lekarz Osrodek Badan Klinicznych
- Centrum Medyczne Lukamed Joanna Luka
- Centrum Medyczne Sw. Lukasza
- 7 Szpital Marynarki Wojennej z Przychodnia SPZOZ im. W. Lasinskiego
- Pro Familia Altera Sp z o.o.
- Nzoz All-Medicus
- Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego SUM
- NZOZ Centrum Medyczne ProMiMed
- Centrum Opieki Zdrowotnej Orkan-Med
- Indywidualna Specjalistyczna Praktyka Lekarska
- GASTROMED Sp. z o.o.
- Allmedica Badania Kliniczne Sp z o.o. Sp K.
- Wojewodzki Specjalistyczny Szpital w Olsztynie
- SOLUMED Centrum Medyczne
- Centrum Medyczne Medyk
- Gabinet Lekarski, Bartosz Korczowski
- Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia
- Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
- Twoja Przychodnia-Szczecinskie Centrum Medyczne
- Centrum Zdrowia MDM
- Zespó Przychodni Specjalistycznych PRIMA
- Endoterapia PFG Sp. z o.o.
- Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy
- Nzoz Vivamed
- Przychodnia EuroMediCare
- PlanetMed
- LexMedica Osrodek Badan Klinicznych
- Hospital de Braga
- Hospital da Senhora da Oliveira Guimarães
- Spitalul Clinic Colentina
- S.C MedLife S.A
- Centrul Medical Unirea SRL
- Centrul de Gastroenterologie Dr. Goldis
- Yusupov Hospital
- SBEI HPE Altai StateMedicalUniversityofMoH andSD
- Baltic Medicine
- CJSC Nasledniki
- FSBIH Central Clinical Hospital of RAS
- FSBI ?State Scientific Centre of Coloproctology" of the MoH of RF; Gastroenterology
- SBHI of NN region ?RCH of NN n.a. N.A.Semashko?
- SEIHPE "Rostov SMU of MoH of RF"
- FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine"; Pulmonology
- SPb SBIH "City Multy-field Hospital # 2"; Intensive Pulmonology and Thoracal Surgery
- SBIH City Clinical Hospital #31
- City Hospital #26
- LLC International Medical Centre ?SOGAZ?
- FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF; Therapy
- Pavlov First Saint Petersburg State Medical University
- SPb SHI "City Hospital #9"
- Medical and Sanitary Division of Severstal
- SBEI HPE "Voronezh State Medical University n.a. N.N. Burdenko" of the MoH of the RF
- Irkutsk State Medical Academy of Continuing Education
- FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS
- BHI of Omsk region Clinical Oncology Dispensary
- SBEI of HPE "Omsk SMA" Ministry of healthcare of RF"
- Stavropol Regional Clinical Diagnostic Consultative Center
- FSBEI HE "Stavropol State Medical University" of Ministry of Healthcare of Russian Federation
- Clinical Center Zvezdara
- Military Medical Academy
- Clinical Center Zemun
- Clinical Center Kragujevac
- General Hospital Djordje Joanovic
- Singapore General Hospital
- Fakultna nemocnica s poliklinikou F.D. Roosevelta
- Nemocnica A.Lena Humenne, n.o.
- KM Management spol. s r.o.
- Gastro I, s.r.o.
- Svet zdravia a.s.
- Endomed, s.r.o.
- Accout Center s.r.o.
- Netcare Universitas Private Hospital
- Dr MJ Prins Practice
- Dr JP Wright Practice
- Emmed Research
- Corporacio Sanitaria Parc Tauli
- Fundacion Hospital de Alcorcon; Servicio de Digestivo
- Centro Médico Teknon
- Hospital Universitari de Girona Dr Josep Trueta
- Hospital Universitario de la Princesa
- Hospital Universitario La Paz
- Hospital Universitario de Fuenlabrada
- Hospital Universitari i Politecnic La Fe
- Hospital Universitario Miguel Servet
- Inselspital-Universitaetsspital Bern
- Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner
- Gazi University Medical Faculty; Gastroenterology
- Haydarpasa Numune Training and Research Hospital; Medical Oncology
- Kocaeli Universitesi Tip Fakultesi; Infectious Diseases
- CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
- Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital
- Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
- CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI
- LLC Gastroenterology Center IBD Team
- CNE Kyiv CCH #18
- CI of Kyiv RC Kyiv Regional Clinical Hospital
- Medical Center of Limited Liability Company Medical Clinic Blagomed
- Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
- CI of Kyiv RC Regional Clinical Hospital #2
- Lviv Regional Clinical Hospital
- CI UDH Dept of Ther SHEI Fac of PGE&Pre-Univ Training
- A.Novak Transcarpathian Regional Clinical Hospital
- RCNECRCH Dept of Surgery, SHEI Ukr BSMU
- CI City Hospital #1
- RCI Chernivtsi RCH Gastroenterology Bukovinsky SMU
- SI Dnipropetrovsk MA of MOHU SI Institute of gastroenterology of AMSU
- GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
- CI of Healthcare Kharkiv CCH #13
- CI Kherson Afanasii and Olha Tropiny City Clinical Hospital
- CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv
- Odessa regional clinical Hospital
- M.V. Sklifosovskyi Poltava RCH Dept of Gastroenterology HSEIU UMSA
- M.V. Sklifosovskyi Poltava RCH Outpatient UMSA HSEIU Ukrainian Medical Stomatological Academy
- Private Small Enterprise Medical Center Pulse
- M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
- MCIC Health Clinic BO LTD TPC Slaomed
- Co Ltd. Diaservice
- CI City Hospital #7
- Addenbrooke's Hospital
- University Hospital Coventry
- Royal Devon and Exeter Hospital (Wonford)
- St James University Hospital
- The Royal London Hospital
- University College London Hospital
- St Thomas Hospital
- King's College London
- Fairfield General Hospital
- Royal Victoria Infirmary
- Nottingham University Hospitals; QMC Campus
- Southampton General Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Part 1: Open-label Extension
Part 2: Safety Monitoring
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).
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).