AzTrials
AzTrials

Ulcerative ColitisPhase 3COTTONWOODNCT02118584

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

A Phase 3 study testing Etrolizumab in people with Ulcerative Colitis, run by Hoffmann-La Roche at 411 sites in 42 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis
What is being tested?
Etrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,822 participants
Where
411 sitesin 42 countries
Study dates
15 Sep 2014to 5 Oct 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

411 sites in 42 countries.

411 sites in 42 countries

United States57 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Asheville Gastroenterology Associates, P.A.

    Asheville, North Carolina, 28801

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

  • Innovative Medical Research of South Florida, Inc.

    Aventura, Florida, 33180

  • Gastroenterology Associates, LLC

    Baton Rouge, Louisiana, 70809

  • Washington Gastroenterology

    Bellevue, Washington, 98004

  • Ehrhardt Clinical Research, LLC

    Belton, Missouri, 64012

  • University of Alabama Medical Center

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital; Crohn's & Colitis Center

    Boston, Massachusetts, 02114

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Northwestern University Feinberg School Of Medicine

    Chicago, Illinois, 60611

  • University of Chicago Medical Center; Medicine, Section of Pulmonary

    Chicago, Illinois, 60637

  • Consultants for Clin. Rsrch

    Cincinnati, Ohio, 45219

  • UC Health Clinical Trials Office; Division of Digestive Diseases

    Cincinnati, Ohio, 45267

  • West Central Gastroenterology d/b/a Gastro Florida

    Clearwater, Florida, 33756

  • Ericksen Research and Development

    Clinton, Utah, 84015

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

  • Texas Digestive Disease Consultants - Dallas

    Dallas, Texas, 75231

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Clinica Peruano Americana S.A.

    Great Neck, New York, 11021

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Kansas City Research Institute, LLC

    Kansas City, Missouri, 64131

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • University of California San Diego Medical Center

    La Jolla, California, 92093-5354

  • Clinical Research of the Rockies

    Lafayette, Colorado, 80026

  • Gastroenterology Associates of Central Georgia

    Macon, Georgia, 31201

  • Gastrointestinal Specialists of Georgia, PC

    Marietta, Georgia, 30060

  • Gastroenterology Center of the Midsouth, P.C.

    Memphis, Tennessee, 38120

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohio, 44060

  • Regenerate Clinical Trials

    Miami, Florida, 33155

  • IMIC, Inc

    Miami Beach, Florida, 33140

  • Regents of the University of Minnesota

    Minneapolis, Minnesota, 55455

  • FQL Research, LLC

    Miramar, Florida, 33025

  • Gastroenterology Group of Naples

    Naples, Florida, 34102

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Aquiant Research

    New Albany, Indiana, 47150

  • Advanced Research Institute, Inc.

    New Port Richey, Florida, 34653

  • NYU Langone Medical Center

    New York, New York, 10016-9451

  • Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)

    New York, New York, 10021

  • Southwest Gastroenterology

    Oak Lawn, Illinois, 60453

  • University of California, Irvine Medical Center

    Orange, California, 92868

  • Internal Medicine Specialists

    Orlando, Florida, 32806

  • McGuire Research Institute; Gastroenterology

    Richmond, Virginia, 23249

  • University of Utah School of Medicine

    Salt Lake City, Utah, 84132

  • Wellness Clinical Research Center

    San Antonio, Texas, 78232

  • SDG Clinical Research

    San Diego, California, 92103

  • University of California at San Francisco

    San Francisco, California, 94115

  • Louisiana Research Center, LLC

    Shreveport, Louisiana

  • Texas Digestive Disease Consultants - Southlake

    Southlake, Texas, 76092

  • Atlanta Gastroenterology Specialists, PC

    Suwanee, Georgia, 30024

  • Cotton-O'Neil Clinical Research Center, Digestive Health

    Topeka, Kansas, 66606

  • Center for Digestive Health

    Troy, Michigan, 48098

  • Tyler Research Institute, LLC

    Tyler, Texas, 75701

  • Ventura Clinical Trials

    Ventura, California, 93003

  • Rocky Mountain Gastroenterology Associates

    Wheat Ridge, Colorado, 80033

  • Shafran Gastroenterology Center

    Winter Park, Florida, 32789

  • Huron Gastroenterology Associates

    Ypsilanti, Michigan, 48197

Other trials in United States

Ukraine29 sites

  • RCNECRCH Dept of Surgery, SHEI Ukr BSMU

    Chernivtsi, Podolia Governorate, 58002

  • RCI Chernivtsi RCH Gastroenterology Bukovinsky SMU

    Chernivtsi, 58002

  • SI Dnipropetrovsk MA of MOHU SI Institute of gastroenterology of AMSU

    Dnipropetrovsk, 49074

  • CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC

    Kharkiv, Kharkiv Governorate, 61037

  • Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital

    Kharkiv, Kharkiv Governorate, 61058

  • GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine

    Kharkiv, 61039

  • CI of Healthcare Kharkiv CCH #13

    Kharkiv, 61124

  • CI Kherson Afanasii and Olha Tropiny City Clinical Hospital

    Kherson, 73000

  • Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

    Kyiv, Kharkiv Governorate, 04107

  • CNE Kyiv CCH #18

    Kyiv, KIEV Governorate, 01030

  • CI of Kyiv RC Kyiv Regional Clinical Hospital

    Kyiv, KIEV Governorate, 04107

  • Medical Center of Limited Liability Company Medical Clinic Blagomed

    Kyiv, KIEV Governorate, 1023

  • Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"

    Kyiv, KIEV Governorate, 2091

  • CI of Kyiv RC Regional Clinical Hospital #2

    Kyiv, KIEV Governorate, 4073

  • CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv

    Kyiv, 02232

  • Lviv Regional Clinical Hospital

    Lviv, KIEV Governorate, 79010

  • Odessa regional clinical Hospital

    Odesa, 65117

  • M.V. Sklifosovskyi Poltava RCH Dept of Gastroenterology HSEIU UMSA

    Poltava, 36011

  • M.V. Sklifosovskyi Poltava RCH Outpatient UMSA HSEIU Ukrainian Medical Stomatological Academy

    Poltava, 36011

  • CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI

    Sumy, Kharkiv Governorate, 40022

  • CI UDH Dept of Ther SHEI Fac of PGE&Pre-Univ Training

    Uzhhorod, KIEV Governorate, 88009

  • A.Novak Transcarpathian Regional Clinical Hospital

    Uzhhorod, KIEV Governorate, 88018

  • Private Small Enterprise Medical Center Pulse

    Vinnytsia, 21001

  • M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU

    Vinnytsia, 21018

  • MCIC Health Clinic BO LTD TPC Slaomed

    Vinnytsia, 21029

  • LLC Gastroenterology Center IBD Team

    Zaporizhzhya, Kharkiv Governorate, 69000

  • CI City Hospital #1

    Zaporizhzhya, Tavria Okruha, 69104

  • Co Ltd. Diaservice

    Zaporizhzhya, 69035

  • CI City Hospital #7

    Zaporizhzhya, 69118

Other trials in Ukraine

Poland28 sites

  • AppleTreeClinics Sp. z o.o.

    ?ód?, 90-349

  • Nasz Lekarz Osrodek Badan Klinicznych

    Bydgoszcz, 85-312

  • Centrum Medyczne Lukamed Joanna Luka

    Chojnice, 89-600

  • Centrum Medyczne Sw. Lukasza

    Cz?stochowa, 42-202

  • 7 Szpital Marynarki Wojennej z Przychodnia SPZOZ im. W. Lasinskiego

    Gdansk, 80-305

  • Pro Familia Altera Sp z o.o.

    Katowice, 40-645

  • Nzoz All-Medicus

    Katowice, 40-660

  • Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego SUM

    Katowice, 40-752

  • NZOZ Centrum Medyczne ProMiMed

    Krakow, 31-637

  • Centrum Opieki Zdrowotnej Orkan-Med

    Ksawerów, 95-054

  • Indywidualna Specjalistyczna Praktyka Lekarska

    Lublin, 20-015

  • GASTROMED Sp. z o.o.

    Lublin, 20-582

  • Allmedica Badania Kliniczne Sp z o.o. Sp K.

    Nowy Targ, 34-400

  • Wojewodzki Specjalistyczny Szpital w Olsztynie

    Olsztyn, 10-561

  • SOLUMED Centrum Medyczne

    Późna, 60-529

  • Centrum Medyczne Medyk

    Rzeszów, 35-055

  • Gabinet Lekarski, Bartosz Korczowski

    Rzeszów, 35-302

  • Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia

    Sopot, 81-756

  • Niepubliczny Zaklad Opieki Zdrowotnej SONOMED

    Szczecin, 70-351

  • Twoja Przychodnia-Szczecinskie Centrum Medyczne

    Szczecin, 71-434

  • Centrum Zdrowia MDM

    Warsaw, 00-189

  • Zespó Przychodni Specjalistycznych PRIMA

    Warsaw, 02-018

  • Endoterapia PFG Sp. z o.o.

    Warsaw, 02-653

  • Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy

    Warsaw, 02-781

  • Nzoz Vivamed

    Warsaw, 03-580

  • Przychodnia EuroMediCare

    Wroc?aw, 50-220

  • PlanetMed

    Wroc?aw, 52-210

  • LexMedica Osrodek Badan Klinicznych

    Wroclaw, 53-114

Other trials in Poland

Russia23 sites

  • SBEI HPE Altai StateMedicalUniversityofMoH andSD

    Barnaul, Altayskiy Kray, 656050

  • Medical and Sanitary Division of Severstal

    Cherepovets, Vologda Oblast, 162600

  • Irkutsk State Medical Academy of Continuing Education

    Irkutsk, 664079

  • FSBIH Central Clinical Hospital of RAS

    Moscow, Moscow Oblast, 119333

  • FSBI ?State Scientific Centre of Coloproctology" of the MoH of RF; Gastroenterology

    Moscow, Moscow Oblast, 123154

  • Yusupov Hospital

    Moskva, Adygeya Republic, 127015

  • SBHI of NN region ?RCH of NN n.a. N.A.Semashko?

    Nizhny Novgorod, Niznij Novgorod, 603126

  • FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS

    Novosibirsk, 630117

  • BHI of Omsk region Clinical Oncology Dispensary

    Omsk, 644013

  • SBEI of HPE "Omsk SMA" Ministry of healthcare of RF"

    Omsk, 644043

  • SEIHPE "Rostov SMU of MoH of RF"

    Rostov-on-Don, Rostov Oblast, 344022

  • FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF; Therapy

    Saint Petersburg, Sankt-Peterburg, 193163

  • FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine"; Pulmonology

    Saint Petersburg, Sankt-Peterburg, 194044

  • SPb SBIH "City Multy-field Hospital # 2"; Intensive Pulmonology and Thoracal Surgery

    Saint Petersburg, Sankt-Peterburg, 194354

  • Baltic Medicine

    Saint Petersburg, Sankt-Peterburg, 194356

  • City Hospital #26

    Saint Petersburg, Sankt-Peterburg, 196247

  • Pavlov First Saint Petersburg State Medical University

    Saint Petersburg, Sankt-Peterburg, 197022

  • SBIH City Clinical Hospital #31

    Saint Petersburg, Sankt-Peterburg, 197110

  • SPb SHI "City Hospital #9"

    Saint Petersburg, Sankt-Peterburg, 197110

  • LLC International Medical Centre ?SOGAZ?

    Saint Petersburg, Sankt-Peterburg, 198035

  • Stavropol Regional Clinical Diagnostic Consultative Center

    Stavropol, 355017

  • FSBEI HE "Stavropol State Medical University" of Ministry of Healthcare of Russian Federation

    Stavropol, 355018

  • SBEI HPE "Voronezh State Medical University n.a. N.N. Burdenko" of the MoH of the RF

    Voronezh, Voronez, 394036

Other trials in Russia

Germany20 sites

  • Charite Universitaetsmedizin Berlin - Campus Charite Mitte

    Berlin, 10117

  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berlin, 12203

  • DRK Kliniken Berlin Westend

    Berlin, 14050

  • Krankenhaus Waldfriede e. V.

    Berlin, 14163

  • Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH

    Bochum, 44789

  • Universitaetsklinikum Erlangen

    Erlangen, 91054

  • Klinikum der Johann Wolfgang Goethe-Universitaet

    Frankfurt, 60590

  • Universitaetsklinikum Freiburg; Urology

    Freiburg im Breisgau, 79106

  • Universitaetsklinikum Halle (Saale)

    Halle, 06120

  • Hamburgisches Forschungsinstitut fuer CED

    Hamburg, 20148

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Gastroenterologie Eppendorfer Baum

    Hamburg, 20249

  • Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie

    Hanover, 30625

  • Universitaetsklinikum Jena; Apotheke des Uniersitätsklinikums Jena

    Jena, 07740

  • Universitaetsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24116

  • Medizinisches Zentrum Klinikum Lueneburg

    Lüneburg, 21339

  • Klinikum Mannheim GmbH Universitätsklinikum

    Mannheim, 68167

  • Universitaetsklinikum Muenster

    Münster, 48149

  • Gemeinschaftspraxis Dres. Joachim Mueller und Steffi Appelt

    Schweinfurt, 97421

  • Universitaetsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Italy19 sites

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh

    Bologna, Emilia-Romagna, 40138

  • Fondazione Poliambulanza Istituto Ospedaliero

    Brescia, Lombardy, 25124

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Tuscany, 50134

  • Azienda Ospedaliera Fatebenefratelli e Oftalmico

    Milan, Lombardy, 20121

  • Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

    Milan, Lombardy, 20162

  • Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

    Milan, Lombardy

  • A.O.U. Policlinico di Modena

    Modena, Emilia-Romagna, 40124

  • Azienda Ospedaliera di Padova

    Padova, Veneto, 35128

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, Sicily, 90127

  • Azienda Ospedaliero Universitaria di Parma

    Parma, Emilia-Romagna, 43126

  • Ospedale di Circolo; Neuropsichiatria Infantile

    Rho, Lombardy, 20017

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    Rome, Lazio, 00133

  • Ospedale Sandro Pertini

    Rome, Lazio, 00157

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Lazio, 00168

  • Azienda Ospedaliera San Camillo Forlanini

    Rome, Lazio, 151

  • Istituto Clinico Humanitas

    Rozzano (MI), Lombardy, 20089

  • I.R.C.C.S Policlinico San Donato

    San Donato Milanese (MI), Lombardy, 20097

  • IRCCS Ospedale Casa Sollievo della Soffenza; Stru Comp di Gastroenterologia ed Endoscopia digest

    San Giovanni Rotondo, Lombardy, 71013

  • Ospedale Mauriziano Umberto I

    Turin, Piedmont, 10128

Other trials in Italy

Brazil17 sites

  • Hospital Felicio Rocho

    Belo Horizonte, Minas Gerais, 30110-068

  • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

    Botucatu, São Paulo, 18618-970

  • CCBR - Brasilia

    Brasília, Federal District, 70200-730

  • CAEP - Centro Avancado de Estudos e Pesquisas Ltda.

    Campinas, São Paulo, 13087-567

  • Centro Digestivo de Curitiba

    Curitiba, Paraná, 80430-160

  • Hospital Universitario Walter Cantidio - UFC

    Fortaleza, Ceará, 60430-370

  • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

    Goiânia, Goiás, 74535-170

  • CECIP - Centro de Estudos Clínicos do Interior Paulista

    Jaú, São Paulo, 17210-190

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital Ernesto Dornelles

    Porto Alegre, Rio Grande do Sul, 90160-092

  • Hospital Universitario Clementino Fraga Filho - UFRJ

    Rio de Janeiro, Rio de Janeiro, 21941-913

  • Hospital Universitario Prof Edgar Santos-Ufba; Ambulatorio Magalhaes Neto 3Andar- Dermatologia

    Salvador, Estado de Bahia, 41110-170

  • Pesquisare Saúde Sociedade Simples

    Santo André, São Paulo, 09080-000

  • Hospital Estadual Mario Covas

    São Bernardo do Campo, São Paulo, 09715-090

  • Hospital Sírio-Libanês

    São Paulo, São Paulo, 01308-050

  • Hospital do Servidor Público Estadual/HSPE-SP

    São Paulo, São Paulo, 04039-901

Other trials in Brazil

South Korea17 sites

  • Dong-A University Hospital

    Busan, 49201

  • Pusan National University Hospital

    Busan, 602-739

  • Kyungpook National University Medical Center

    Daegu, 41404

  • Keimyung University Dongsan Medical Center

    Daegu, 41931

  • Kyungpook National University Hospital

    Daegu, 41944

  • Yeungnam Univ. Hospital

    Daegu, 705-717

  • Korea University Ansan Hospital

    Gyeonggi-do, 15355

  • CHA Bundang Medical Centre; CHA university

    Seongnam, 13520

  • Seoul National University Bundang Hospital

    Seongnam-si, 463-707

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Samsung Medical Center

    Seoul, 06351

  • Asan Medical Center.

    Seoul, 5505

  • The Catholic University of Korea St. Vincent's Hospital

    Suwon, 442-723

  • Ajou University Hospital

    Suwon, 443-721

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju, 26426

Other trials in South Korea

Hungary16 sites

  • DRC Gyogyszervizsgalo Kozpont Kft

    Balatonfüred, 8230

  • Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

    Békéscsaba, 5600

  • Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika

    Budapest, 1088

  • Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo

    Budapest, 1125

  • Pannónia Klinika Magánorvosi

    Budapest, 1136

  • Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely

    Budapest, H-1077

  • Endomedix Diagnosztikai Kozpont

    Budapest

  • Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont

    Debrecen, 4025

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Markhot Ferenc Oktato Korhaz es Rendelointezet

    Eger, 3300

  • Petz Aladar Megyei Oktato Korhaz

    Győr, 9024

  • Pest Megyei Flor Ferenc Korhaz

    Kistarcsa, 2143

  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

    Miskolc, 3526

  • Pecsi Tudomanyegyetem

    Pécs, 7624

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár, 8000

  • Csongrad Megyei Dr. Bugyi Istvan Korhaz

    Szentes, 6600

Other trials in Hungary

Australia14 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Bankstown-Lidcombe Hospital

    Bankstown, New South Wales, 2200

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Footscray Hospital

    Footscray, Victoria, 3011

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Launceston General Hospital; Gastroenterology Research

    Launceston, Tasmania, 7250

  • Mater Adult Hospital

    Mackay, Queensland, 4740

  • St Frances Xavier Cabrini Hospital

    Malvern, Victoria, 3144

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics

    Parkville, Victoria, 3050

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Canada14 sites

  • University of Calgary

    Calgary, Alberta, T2N 2T9

  • Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology

    Edmonton, Alberta, T6G 2X8

  • Centre de santé et de services sociaux Champlain-Charles-Le Moyne

    Greenfield Park, Quebec, J4V 2H1

  • Guelph GI & Surgery Clinic

    Guelph, Ontario, N1H 3R3

  • Queen Elizabeth II Health Sciences Centre; Gastroenterology Research

    Halifax, Nova Scotia, B3H 1V7

  • Hotel Dieu de Levis

    Lévis, Quebec, G6V 3Z1

  • University Hospital - London Health Sciences Centre

    London, Ontario, N6A 5A5

  • Hôpital Maisonneuve - Rosemont

    Montreal, Quebec, H1T 2M4

  • Taunton Health Centre

    Oshawa, Ontario, L1H 7K4

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

  • Toronto Liver Centre

    Toronto, Ontario, M6H 3M1

  • Pacific Gastroenterology Associates

    Vancouver, British Columbia, V6Z 2K5

  • Toronto Digestive Disease Associates

    Vaughan, Ontario, L4L 4Y7

Other trials in Canada

France14 sites

  • CHU Amiens - Hopital Sud

    Amiens, 80054

  • CHU de Caen Hopital Cote de Nacre

    Caen, 14033

  • CHU Tours - Hôpital Trousseau

    Chambray-lès-Tours, 37170

  • Hôpital Beaujon

    Clichy, 92110

  • Hopital Claude Huriez - CHU Lille

    Lille, 59037

  • CHU Hopital Saint Eloi

    Montpellier, 34295

  • CHU Nice - Hopital de l'Archet 2

    Nice, 06202

  • Hôpital Saint-Louis

    Paris, 75475

  • CHU Bordeaux - Hôpital Haut-Lévêque

    Pessac, 33600

  • Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie

    Pierre-Bénite, 69495

  • CHU Saint Etienne - Hôpital Nord

    Saint-Etienne, 42055

  • Höpital Hautepierre; Pediatrie1

    Strasbourg, 67098

  • CHU de Toulouse - Hôpital Rangueil

    Toulouse, 31059

  • Hôpital de Brabois Adultes

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Bulgaria12 sites

  • Medical Centre "Asklepii", OOD

    Dupnitsa, 2600

  • DCC Sv. Pantaleymon OOD; II-nd Clinic of Neurology

    Pleven, 5800

  • Medical center Medconsult Pleven OOD

    Pleven, 5800

  • MHAT - Ruse, AD

    Rousse, 7002

  • MHAT "Hadzhi Dimitar", OOD

    Sliven, 8800

  • "City Clinic UMHAC" EOOD

    Sofia, 1407

  • UMHAT "Sv. Ivan Rilski", EAD

    Sofia, 1431

  • UMHAT Tsaritsa Yoanna - ISUL, EAD

    Sofia, 1527

  • Diagnostic Consultation Center CONVEX EOOD

    Sofia, 1680

  • Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

    Stara Zagora, 6000

  • MHAT 'Sv. Marina', EAD; First Children's Clinic

    Varna, 9010

  • MC Medica Plus

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Czechia12 sites

  • Vojenska nemocnice Brno

    Brno, 636 00

  • Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika

    Brno, 65691

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Hepato-Gastroenterologie HK, s.r.o.

    Hradec Králové, 500 12

  • Oblastni nemocnice Kladno, a.s., nemocnice Stredoces. kraje; Endoskopicke centrum

    Kladno, 272 59

  • PreventaMed, s.r.o.

    Olomouc, 779 00

  • Mestska Nemocnice Ostrava

    Ostrava, 728 80

  • Pardubicka krajska nemocnice a.s.

    Pardubice, 532 03

  • ISCARE a.s.

    Prague, 170 04

  • Nemocnice Na Bulovce

    Prague, 180 01

  • Krajska zdravotni, a.s. ? Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni

    Ústí nad Labem, 401 13

  • Krajska nemocnice T. Bati, a.s.

    Zlín, 76001

Other trials in Czechia

United Kingdom12 sites

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

  • University Hospital Coventry

    Coventry, CV2 2DX

  • Royal Devon and Exeter Hospital (Wonford)

    Exeter, EX2 5DW

  • St James University Hospital

    Leeds, LS9 7TF

  • The Royal London Hospital

    London, E1 1FR

  • University College London Hospital

    London, N7 9NH

  • St Thomas Hospital

    London, SE1 7EH

  • King's College London

    London, SE5 9NU

  • Fairfield General Hospital

    Manchester, M8 5RB

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

  • Nottingham University Hospitals; QMC Campus

    Nottingham, NG7 2UH

  • Southampton General Hospital

    Southampton, SO16 6YD

Other trials in United Kingdom

India10 sites

  • K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre

    Belagavi, Karnataka, 590010

  • M. S. Ramaiah Medical College and Hospital

    Bengaluru, Karnataka, 560054

  • Deccan College of Medical Sciences and Allied Hospitals; Department of Gastroenterology

    Hyderabad, Andhra Pradesh, 500058

  • S. R. Kalla Memorial Gastro & General Hospital

    Jaipur, Rajasthan, 302001

  • Dayanand Medical College and Hospital

    Ludhiana, Punjab, 141001

  • Kasturba Medical College & Hospital

    Manglore, Karnataka, 575001

  • Midas institute of Gastroenterology

    Nagpur, Maharashtra, 440012

  • Ruby Hall Clinic

    Pune, Maharashtra, 411001

  • King Edward Memorial Hospital Research Centre

    Pune, 411011

  • Nirmal Hospital

    Surat, Gujarat, 395002

Other trials in India

Belgium9 sites

  • GZA Ziekenhuizen - Campus Sint-Vincentius

    Antwerp, 2018

  • Imeldaziekenhuis

    Bonheiden, 2820

  • CHU St Pierre (St Pierre)

    Brussels, 1000

  • UZ Brussel

    Brussels, 1090

  • Cliniques Universitaires Saint-Luc; Pharmacy

    Brussels, 1200

  • UZ Gent

    Ghent, 9000

  • AZ Sint Elisabeth Herentals

    Herentals, 2200

  • UZ Leuven; Neurology

    Leuven, 3000

  • AZ Delta (Campus Rumbeke)

    Roeselare, 8800

Other trials in Belgium

Spain9 sites

  • Fundacion Hospital de Alcorcon; Servicio de Digestivo

    Alcorcón, Madrid, 28922

  • Centro Médico Teknon

    Barcelona

  • Hospital Universitari de Girona Dr Josep Trueta

    Girona, 17007

  • Hospital Universitario de la Princesa

    Madrid, 28006

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario de Fuenlabrada

    Madrid, 28942

  • Corporacio Sanitaria Parc Tauli

    Sabadell, Barcelona, 08208

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Israel8 sites

  • Bnai Zion Medical Center; Internal Medicine

    Haifa, 3339419

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 9112001

  • Holy Family Hospital

    Nazareth, 1641101

  • Rabin Medical Center Beilinson Campus; Gaucher Clinic Genetics Institute

    Petach Tiqwa, 49100

  • Kaplan Medical Center

    Rehovot, 7610001

  • Assaf Harofeh

    Rishon LeZiyyon, 7505001

  • Chaim Sheba Medical Center; Pediatrics B North and Pediatric Endocrinology Unit

    Tel HaShomer, 52621

Other trials in Israel

Slovakia7 sites

  • Fakultna nemocnica s poliklinikou F.D. Roosevelta

    Banská Bystrica, 974 01

  • Nemocnica A.Lena Humenne, n.o.

    Humenné, 066 01

  • Endomed, s.r.o.

    Košice, 040 01

  • KM Management spol. s r.o.

    Nitra, 94901

  • Gastro I, s.r.o.

    Prešov, 080 01

  • Svet zdravia a.s.

    Rimavská Sobota, 979 01

  • Accout Center s.r.o.

    Šahy, 936 01

Other trials in Slovakia

New Zealand6 sites

  • North Shore Hospital

    Auckland, 0620

  • Middlemore Hospital

    Auckland

  • Dunedin Hospital

    Dunedin

  • Waikato Hospital

    Hamilton, 3248

  • Shakespeare Specialist Group

    Takapuna, 0620

  • Tauranga Hospital

    Tauranga, 3143

Other trials in New Zealand

Estonia5 sites

  • OÜ Innomedica

    Tallinn, 10117

  • East Tallinn Central Hospital

    Tallinn, 10138

  • West Tallinn Central Hospital

    Tallinn, 10617

  • North Estonia Medical Centre Foundation

    Tallinn, 13419

  • Tartu University Hospital

    Tartu, 51014

Other trials in Estonia

Mexico5 sites

  • Phylasis Clinicas Research S de RL de CV

    Cuautitlán Izcalli, 54769

  • Centro Integral en Reumatología S.A. de C.V. (CIRSA)

    Guadalajara, Jalisco, 44160

  • Accelerium S. de R.L. de C.V.

    Monterrey, Nuevo León, 64000

  • Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León

    Monterrey, Nuevo León, 64460

  • Centro Regiomontano de Estudios Clínicos Roma S.C.

    Monterrey, Nuevo León, 64610

Other trials in Mexico

Serbia5 sites

  • Clinical Center Zvezdara

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11040

  • Clinical Center Zemun

    Belgrade, 11080

  • Clinical Center Kragujevac

    Kragujevac, 34000

  • General Hospital Djordje Joanovic

    Zrenjanin, 23000

Other trials in Serbia

Malaysia4 sites

  • Hospital Raja Perempuan Zainab II; Department of Medicine

    Kota Bharu, 15586

  • Pusat Perubatan Universiti Kebangsaan Malaysia

    Kuala Lumpur, FED. Territory of Kuala Lumpur, 56000

  • University Malaya Medical Center

    Kuala Lumpur, FED. Territory of Kuala Lumpur, 59100

  • Hospital Tengku Ampuan Afzan

    Kuantan, Pahang, 25100

Other trials in Malaysia

Romania4 sites

  • S.C MedLife S.A

    Bucharest, 010719

  • Centrul Medical Unirea SRL

    Bucharest, 040055

  • Spitalul Clinic Colentina

    Bucharest, 772202

  • Centrul de Gastroenterologie Dr. Goldis

    Timișoara, 300002

Other trials in Romania

South Africa4 sites

  • Netcare Universitas Private Hospital

    Bloemfontein, 9301

  • Dr MJ Prins Practice

    Cape Town, 7500

  • Dr JP Wright Practice

    Cape Town, 7708

  • Emmed Research

    Pretoria, 0002

Other trials in South Africa

Denmark3 sites

  • Ålborg Universitets Hospital; Gastromedicinsk

    Aalborg, 9000

  • Herlev og Gentofte Hospital

    Hellerup, 2900

  • Rigshospitalet; Afdeling for Tarmsvigt og Leversygdomme

    København Ø, 2100

Other trials in Denmark

Latvia3 sites

  • Central Outpatient Clinic

    Daugavpils, LV-5401

  • Pauls Stradins Clinical University Hospital

    R?ga, LV-1002

  • Digestive Diseases Center "Gastro"

    R?ga, LV-1079

Other trials in Latvia

Lithuania3 sites

  • Hospital of Lithuanian University of Health. Sciences Kaunas Clinics

    Kaunas, 50009

  • Klaipeda Seamen's Hospital, Public Institution

    Klaipėda, 92288

  • Vilnius University Hospital Santariskiu Clinic, Public Institution; Cardiology

    Vilnius, LT-08661

Other trials in Lithuania

Netherlands3 sites

  • Amsterdam UMC Location VUMC

    Amsterdam, 1081 HV

  • Amsterdam UMC Location AMC

    Amsterdam, 1105 AZ

  • Radboudumc

    NL -nijmegen, 6525 GA

Other trials in Netherlands

Turkey (Türkiye)3 sites

  • Gazi University Medical Faculty; Gastroenterology

    Ankara, 06500

  • Haydarpasa Numune Training and Research Hospital; Medical Oncology

    Istanbul, 34668

  • Kocaeli Universitesi Tip Fakultesi; Infectious Diseases

    Kocaeli, 41380

Other trials in Turkey (Türkiye)

Argentina2 sites

  • Instituto Medico DAMIC

    Córdoba, X5003DCE

  • Hospital Provincial del Centenario

    Rosario, S2002KDS

Other trials in Argentina

Austria2 sites

  • LKH - Universitätsklinikum der PMU Salzburg

    Salzburg, 5020

  • Medizinische Universität Wien

    Vienna, 1090

Other trials in Austria

Colombia2 sites

  • RTS - Fundación Valle de Lili

    Cali, 0

  • Instituto de Coloproctologia ICO S.A.S.

    Medellín, 050025

Other trials in Colombia

Croatia2 sites

  • Clinical Hospital Centre Osijek

    Osijek, 31000

  • Clinical Hospital Sveti Duh; Department of Neurology

    Zagreb, 10000

Other trials in Croatia

Portugal2 sites

  • Hospital de Braga

    Braga, 4710-243

  • Hospital da Senhora da Oliveira Guimarães

    Guimarães, 4835-044

Other trials in Portugal

Switzerland2 sites

  • Inselspital-Universitaetsspital Bern

    Bern, 3010

  • Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner

    Bern, 3012

Other trials in Switzerland

Greece1 site

  • University General Hospital of Heraklion

    Heraklio, 711 10

Other trials in Greece

Hong Kong1 site

  • University of Hong Kong

    Hong Kong

Other trials in Hong Kong

Norway1 site

  • Akershus universitetssykehus HF

    Lørenskog, 1478

Other trials in Norway

Singapore1 site

  • Singapore General Hospital

    Singapore, 169608

Other trials in Singapore

About this study

Official title: 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.

Being tested
Etrolizumab
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EtrolizumabDrug

    Also called RG7413, RO5490261, PRO145223, rhuMAb Beta7

    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.

Study groups in NCT02118584
Study groupRoleWhat they receive
Part 1: Open-label ExtensionExperimentalParticipants 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).
Receives: Drug: Etrolizumab
Part 2: Safety MonitoringNo interventionAll 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS)

    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.

    Measured: 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

  2. Part 1: Percentage of Participants With Remission as Determined by the Mayo Clinic Score (MCS)

    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.

    Measured: At OLE Week 108

  3. Part 1: Percentage of Participants With Endoscopic Remission

    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.

    Measured: At OLE Week 108

  4. 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]

    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.

    Measured: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)

  5. Part 1: Number of Participants With Serious Adverse Events (SAEs)

    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.

    Measured: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)

  6. Part 1: Number of Participants With Infection Related AEs and Severity of Infection-Related AEs Assessed Using NCI CTCAE v4.0

    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.

    Measured: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)

  7. Part 1: Number of Participants With Serious Infection Related AES

    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.

    Measured: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)

  8. Part 1: Number of Participants With Injection Site Reactions and Severity of Injection Site Reactions Assessed Using NCI CTCAE v4.0

    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.

    Measured: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)

  9. Part 1: Number of Participants With AEs Leading to Etrolizumab Discontinuation

    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.

    Measured: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)

  10. Part 1: Number of Participants With Malignancies

    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.

    Measured: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)

  11. Part 1: Number of Participants With Hypersensitivity Reactions and Severity of Hypersensitivity Assessed Using NCI-CTCAE v4.0

    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.

    Measured: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)

  12. Part 2: Number of Participants With Confirmed Progressive Multifocal Leukoencephalopathy (PML) During the Post-Treatment PML Monitoring Period

    Measured: From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2014 (estimated)
  2. Study start15 Sep 2014
  3. Primary completion5 Oct 2023
  4. Study completion5 Oct 2023

Why it stopped: The study was terminated due to program discontinuation, based on mixed efficacy results in the parent studies. There were no safety concerns.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,822 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02118584
Sponsor's protocol ID
GA28951
Other IDs
2013-004435-72
Acronym
COTTONWOOD
Status last verified
Sep 2024
First submitted
16 Apr 2014
Last updated
23 Oct 2024
Data monitoring committee
Yes

Publications

  • Sandborn WJ, Vermeire S, Tyrrell H, Hassanali A, Lacey S, Tole S, Tatro AR; Etrolizumab Global Steering Committee. Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program. Adv Ther. 2020 Jul;37(7):3417-3431. doi: 10.1007/s12325-020-01366-2. Epub 2020 May 22.

    PubMed 32445184

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Etrolizumab in people with Ulcerative Colitis, run by Hoffmann-La Roche at 411 sites in 42 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 411 sites in United States, Ukraine, Poland, Russia, Germany and 37 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02118584, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.

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