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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02403323
Other study ID # GA29145
Secondary ID 2014-003855-76
Status Terminated
Phase Phase 3
First received
Last updated
Start date June 8, 2015
Est. completion date October 9, 2023

Study information

Verified date October 2023
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This open-label extension and safety monitoring study is composed of two parts: Part 1 will evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants with moderately to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144 (NCT02394028) and who meet eligibility criteria for enrollment into Part 1. In Part 2, participants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 [NCT02394028]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events.


Recruitment information / eligibility

Status Terminated
Enrollment 900
Est. completion date October 9, 2023
Est. primary completion date October 9, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Part 1 Open-Label Extension: - Patients previously enrolled in etrolizumab Phase III study GA29144 (NCT02394028) who meet the eligibility criteria for open-label etrolizumab as described in the protocol Part 2 Safety Monitoring: - Patients who participated in etrolizumab Phase III study GA29144 (NCT02394028) and are not eligible or choose not to enter Part 1 - Patients who transfer from Part 1 - Completion of the 12-week safety follow-up period prior to entering Exclusion Criteria: Part 1 Open-Label Extension: - Any new, significant, uncontrolled condition Part 2 Safety Monitoring: - No exclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Etrolizumab
105 mg etrolizumab subcutaneous administration once every 4 weeks

Locations

Country Name City State
Argentina Hospital Italiano Caba
Australia Flinders Medical Centre Bedford Park South Australia
Australia Concord Repatriation General Hospital Concord New South Wales
Australia St Vincent's Hospital Melbourne Fitzroy Victoria
Australia Footscray Hospital Footscray Victoria
Australia The Canberra Hospital Garran Australian Capital Territory
Australia Royal Brisbane and Women's Hospital Herston Queensland
Australia St Frances Xavier Cabrini Hospital Malvern Victoria
Australia Fiona Stanley Hospital Murdoch Western Australia
Australia Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics Parkville Victoria
Australia The Alfred Hospital Prahan Victoria
Australia University of the Sunshine Coast Sippy Downs Queensland
Australia Mater Adult Hospital South Brisbane Queensland
Australia Princess Alexandra Hospital Woolloongabba Queensland
Austria LKH - Universitätsklinikum der PMU Salzburg Salzburg
Austria Medizinische Universität Wien Wien
Belgium UZ Brussel Brussel
Belgium CHU St Pierre (César de Paepe) X Bruxelles
Belgium ULB Hopital Erasme; Service de Néphrologie Bruxelles
Belgium UZ Antwerpen Edegem
Belgium AZ Maria Middelares Gent
Brazil Hospital Felicio Rocho Belo Horizonte MG
Brazil UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu Botucatu SP
Brazil Centro Digestivo de Curitiba Curitiba PR
Brazil Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda Goiânia GO
Brazil Hospital Sao Vicente de Paulo Passo Fundo RS
Brazil Hospital das Clinicas - UFRGS Porto Alegre RS
Brazil Hospital Ernesto Dornelles Porto Alegre RS
Brazil Hospital Universitario Clementino Fraga Filho - UFRJ Rio de Janeiro RJ
Brazil Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A Rio de Janeiro RJ
Brazil Pesquisare Saúde Sociedade Simples Santo Andre SP
Brazil Praxis Pesquisa Médica Santo Andre SP
Brazil Hospital Estadual Mario Covas Sao Bernardo Do Campo SP
Brazil Hospital de Base de Sao Jose do Rio Preto Sao Jose do Rio Preto SP
Brazil Hospital Sírio-Libanês Sao Paulo SP
Brazil Universidade Federal de Sao Paulo - UNIFES Sao Paulo SP
Brazil Hospital do Servidor Público Estadual/HSPE-SP São Paulo SP
Bulgaria "City Clinic UMHAC" EOOD Sofia
Bulgaria UMHAT "Sv. Ivan Rilski", EAD Sofia
Canada University of Calgary Calgary Alberta
Canada Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology Edmonton Alberta
Canada Queen Elizabeth II Health Sciences Centre; Gastroenterology Research Halifax Nova Scotia
Canada University Hospital - London Health Sciences Centre London Ontario
Canada Hôpital Maisonneuve - Rosemont Montreal Quebec
Canada McGill University Health Centre - Glen Site Montreal Quebec
Canada Taunton Health Centre Oshawa Ontario
Canada The Ottawa Hospital - Riverside Campus; Gastrointestinal Clinical Research Unit Ottawa Ontario
Canada Royal University Hospital Saskatoon Saskatchewan
Canada Mount Sinai Hospital Toronto Ontario
Canada (G.I.R.I.) GI Research Institute Vancouver British Columbia
Canada Toronto Digestive Disease Associates Vaughan Ontario
Canada Winnipeg Regional Health Authority; Neurosurgery Department Winnipeg Manitoba
Croatia Clinical Hospital Centre Osijek Osijek
Croatia General Hospital Pula Pula
Croatia Clinical Hospital Center Sestre Milosrdnice Zagreb
Czechia Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika Brno
Czechia Vojenska nemocnice Brno Brno
Czechia Nemocnice Ceske Budejovice a.s. Ceske Budejovice
Czechia Fakultni nemocnice Hradec Kralove Hradec Kralove
Czechia Gastroenterologie s.r.o. Hradec Kralove
Czechia Hepato-Gastroenterologie HK, s.r.o. Hradec Kralove
Czechia PreventaMed, s.r.o. Olomouc
Czechia Fakultni nemocnice Ostrava Ostrava - Poruba
Czechia Fakultni nemocnice Kralovske Vinohrady Praha
Czechia ISCARE a.s. Praha 7
Estonia North Estonia Medical Centre Foundation Tallinn
Estonia West Tallinn Central Hospital Tallinn
Estonia Tartu University Hospital Tartu
France CHU Amiens - Hopital Sud Amiens
France CHU de Caen Hopital Cote de Nacre Caen
France Hôpital Beaujon Clichy cedex
France Hopital Claude Huriez - CHU Lille Lille
France CHU NANTES - Hôtel Dieu; Pharmacy Nantes
France CHU Nice - Hopital de l'Archet 2 Nice
France Hôpital Saint-Louis Paris
France Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN Pessac
France Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie Pierre-Benite
France CHU du Reims - Hopital Robert Debré Reims
France CHU Saint Etienne - Hôpital Nord Saint Etienne
France Höpital Hautepierre; Pediatrie1 Strasbourg
France Hôpital de Brabois Adultes Vandoeuvre-les-nancy
Germany Charité Campus Virchow-Klinikum; Department of Cardiology Berlin
Germany Charite-Campus Virchow Klinikum; Hepatologie und Gastroenterologie Berlin
Germany Krankenhaus Waldfriede e. V. Berlin
Germany Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH Bochum
Germany Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt
Germany Medizinische Hochschule Hannover Hannover
Germany Klinikum Mannheim GmbH Universitätsklinikum Mannheim
Germany Gemeinschaftspraxis Schweinfurt
Germany Universitaetsklinikum Ulm Ulm
Hungary Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza Bekescsaba
Hungary Obudai Egeszsegugyi Centrum Kft. Budapest
Hungary Pannonia Maganorvosi Centrum Budapest
Hungary Semmelweis Egyetem Budapest
Hungary Szt Janos Korhaz es EbudaiEgyesitettKorhazak Budapest
Hungary Debreceni Egyetem Klinikai Központ; B?rgyógyászati Klinika Debrecen
Hungary Petz Aladar Megyei Oktato Korhaz Gyor
Hungary Pest Megyei Flor Ferenc Korhaz Kistarcsa
Israel Haemek Medical Center Afula
Israel Soroka University Medical Centre Beer Sheva
Israel Wolfson Medical Center Holon
Israel Shaare Zedek Medical Center Jerusalem
Israel Holy Family Hospital Nazareth
Israel Rabin Medical Center-Beilinson Campus Petach Tikva
Israel Tel Aviv Sourasky Medical Center; Pharmacy Tel Aviv
Italy Azienda Ospedaliera Universitaria Careggi Florence Toscana
Italy Asst Fatebenefratelli Sacco (Fatebenefratelli) Milano Lombardia
Italy A.O.U. Policlinico di Modena Modena Emilia-Romagna
Italy Azienda Ospedaliera San Camillo Forlanini Roma Lazio
Italy Policlinico Universitario Agostino Gemelli; Farmacia Roma Lazio
Italy Istituto Clinico Humanitas Rozzano (MI) Lombardia
Italy I.R.C.C.S Policlinico San Donato San Donato Milanese (MI) Lombardia
Korea, Republic of Dong-A University Hospital Busan
Korea, Republic of Kyungpook National University Hospital Daegu
Korea, Republic of Yeungnam Univ. Hospital Daegu
Korea, Republic of Korea University Ansan Hospital Gyeonggi-do
Korea, Republic of CHA Bundang Medical Centre; CHA university Seongnam
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Kangbuk Samsung Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Yonsei University Wonju Severance Christian Hospital Wonju-Si
Latvia Pauls Stradins Clinical University Hospital R?ga
Latvia Riga East Clinical University Hospital, clinic "Gailezers"; Department of Endoscopy Riga
Lithuania Hospital of Lithuanian University of Health. Sciences Kaunas Clinics Kaunas
Lithuania Vilnius University Hospital Santariskiu Clinics, Public Inst; Department of Clinical Pharmacology Vilnius
Mexico Medical Care & Research SA de CV Mérida Yucatan
Mexico Clinical Research Institute Tlalnepantla de Baz Mexico CITY (federal District)
Netherlands Amsterdam UMC Location AMC Amsterdam
Netherlands Amsterdam UMC, Locatie VUMC; Gastroenterology Amsterdam
Netherlands Leids Universitair Medisch Centrum; Cardiology Leiden
Netherlands Maastricht University Medical Center Maastricht
Netherlands Erasmus Medisch Centrum Rotterdam
Netherlands Zuyderland Medisch Centrum - Sittard Geleen Sittard-Geleen
Netherlands ETZ TweeSteden Tilburg
New Zealand North Shore Hospital Auckland
New Zealand Christchurch Hospital NZ Christchurch
New Zealand Dunedin Public Hospital Dunedin
New Zealand Waikato Hospital Hamilton
New Zealand Hutt Hospital Lower Hutt
New Zealand Shakespeare Specialist Group Takapuna
New Zealand Tauranga Hospital Tauranga
Poland SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego Bia?ystok
Poland Nasz Lekarz Osrodek Badan Klinicznych Bydgoszcz
Poland Elblaski Szpital Specjalistyczny z Przychodnia SP ZOZ Elblag
Poland ETG Kielce Kielce
Poland Centrum Opieki Zdrowotnej Orkan-Med Ksawerow
Poland Indywidualna Specjalistyczna Praktyka Lekarska Lublin
Poland Allmedica Badania Kliniczne Sp z o.o. Sp K. Nowy Targ
Poland Centrum Medyczne "MEDYK" Rzeszow
Poland Gabinet Lekarski, Bartosz Korczowski Rzeszów
Poland Niepubliczny Zaklad Opieki Zdrowotnej SONOMED Szczecin
Poland Twoja Przychodnia-Szczecinskie Centrum Medyczne Szczecin
Poland Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj Toru?
Poland Centrum Zdrowia MDM Warszawa
Poland Zespó Przychodni Specjalistycznych PRIMA Warszawa
Poland PlanetMed sp. z o.o. Wroc?aw
Poland Przychodnia EuroMediCare Wroc?aw
Poland LexMedica Osrodek Badan Klinicznych Wroclaw
Romania S.C MedLife S.A Bucuresti
Romania Spitalul Clinic Colentina Sector 2
Romania Centrul de Gastroenterologie Dr. Goldis Timisoara
Russian Federation SBEI HPE Altai StateMedicalUniversityofMoH andSD Barnaul Altaj
Russian Federation Irkutsk State Medical Academy of Continuing Education Irkutsk
Russian Federation LEC at SBIH of Moscow "City Clinical Hospital # 24"; Gastroenterology Moscow Moskovskaja Oblast
Russian Federation LLC "Novosibirsk GastroCenter" Novosibirsk Altaj
Russian Federation SBEIHPE Novosibirsk State Medical University Novosibirsk
Russian Federation BHI of Omsk region Clinical Oncology Dispensary Omsk
Russian Federation Evromedservis LCC Pushkin Sankt Petersburg
Russian Federation SEIHPE "Rostov SMU of MoH of RF" Rostov-on-Don Rostov
Russian Federation Federal State Military Educational Inst. of High Prof. Edu Military Medical Acad; Therapy department Saint-Petersburg Sankt Petersburg
Russian Federation North-Western Medical University n.a. I.I. Mechnikov; Rheumatology Sankt-peterburg Sankt Petersburg
Russian Federation SBIH City Clinical Hospital #31 Sankt-peterburg Sankt Petersburg
Russian Federation Pavlov First Saint Petersburg State Medical University St. Petersburg Sankt Petersburg
Russian Federation Baltic Medicine St.Petersburg Leningrad
Serbia Clinical Center Zvezdara Belgrade
Serbia Military Medical Academy Belgrade
Serbia General Hospital Djordje Joanovic Zrenjanin
Slovakia Accout Center s.r.o. Ĺ ahy
Slovakia KM Management spol. s r.o. Nitra
Slovakia Endomed, s.r.o. Vranov Nad Top?ou
South Africa Dr D Epstein Practice Cape Town
South Africa Emmed Research Pretoria
Spain Hospital Clínic i Provincial; Servicio de Farmacia Barcelona
Spain Hospital Reina Sofia; Medical Oncology Cordoba
Spain Hospital Universitario de Bellvitge Hospitalet de Llobregat Barcelona
Spain Hospital Juan Ramón Jiménez Huelva
Spain Hospital Universitario de Fuenlabrada Madrid
Spain Hospital Universitario de la Princesa Madrid
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitario Virgen del Rocio Sevilla
Spain Hospital Universitario Virgen Macarena Sevilla
Spain Hospital Universitari i Politecnic La Fe Valencia
Spain Hospital Universitario Miguel Servet Zaragoza
Switzerland Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner Bern
Switzerland Inselspital-Universitaetsspital Bern Bern
Switzerland Universitätsspital Zürich Zürich
Turkey Gazi University Medical Faculty Ankara
Turkey Hacettepe University Medical Faculty; Gastroenterology Ankara
Turkey Acibadem Fulya Hospital; Neurology Istanbul
Turkey Haydarpasa Numune Training and Research Hospital; Gastroenterology Istanbul
Turkey Ege University Medical Faculty Izmir
Turkey Medeniyet University Goztepe Training and Research Hospital. Kadiköy
Turkey Kocaeli Universitesi Tip Fakultesi; Infectious Diseases Kocaeli
Turkey Acibadem Kozyatagi Hospital; Gastroenterology Kozyata?i
Ukraine RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU Chernivtsi
Ukraine Ivano-Frankivsk Regional Clinical Hospital Ivano-Frankivsk Kuban People's Republica
Ukraine CHI Kharkiv City Clinical Hospital #13 Kharkiv
Ukraine CI of Healthcare Kharkiv Reg Clin Hosp-Center of Med Emergency & Accident Medicine Kharkiv Kharkiv Governorate
Ukraine CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC Kharkiv Kharkiv Governorate
Ukraine CI of Kyiv RC Regional Clinical Hospital #2 Kyiv KIEV Governorate
Ukraine Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+" Kyiv KIEV Governorate
Ukraine Medical Center of Limited Liability Company Medical Clinic Blagomed Kyiv KIEV Governorate
Ukraine Lviv Regional Clinical Hospital Lviv KIEV Governorate
Ukraine Railway Transport Odesa CH of Healthcare Ctr Branch of PJSC Ukrainian Railway Dept of Therapy #2 Odesa
Ukraine M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU Vinnytsia
Ukraine MCIC MC LLC Health Clinic Vinnytsia
Ukraine Private Small Enterprise Medical Center Pulse Vinnytsia
Ukraine LLC Gastroenterology Center IBD Team Zaporizhzhia Kharkiv Governorate
United Kingdom Royal Victoria Hospital Belfast
United Kingdom University Hospital Coventry Coventry
United Kingdom Royal Devon and Exeter Hospital (Wonford) Exeter
United Kingdom Queen Elizabeth Hospital Kings Lynn
United Kingdom St James University Hospital Leeds
United Kingdom Royal Liverpool University Hospital Liverpool
United Kingdom University College London Hospital London
United Kingdom Whipps Cross Hospital London
United Kingdom Fairfield General Hospital Manchester
United Kingdom Royal Victoria Infirmary; Stroke unit Newcastle Upon Tyne
United Kingdom Nottingham University Hospitals Queen's Medical Centre Nottingham
United Kingdom Royal Berkshire Hospital Reading
United Kingdom Southampton General Hospital Southampton
United States University of Michigan Ann Arbor Michigan
United States Valley Gastroenterology Consultants Arcadia California
United States Atlanta Gastroenterology Associates Atlanta Georgia
United States Emory University Hospital Atlanta Georgia
United States Innovative Medical Research of South Florida Aventura Florida
United States Gastroenterology Associates, LLC Baton Rouge Louisiana
United States Ehrhardt Clinical Research, LLC Belton Missouri
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States Charlotte Gastroenterology and Hepatology, P.L.L.C Charlotte North Carolina
United States Northwestern Uni-Feinberg School of Medicine Chicago Illinois
United States University of Chicago Medical Center Chicago Illinois
United States Consultants for Clinical Research Inc. Cincinnati Ohio
United States West Central Gastroenterology d/b/a Gastro Florida Clearwater Florida
United States Ericksen Research and Development Clinton Utah
United States Peak Gastroenterology Associates Colorado Springs Colorado
United States Columbus Regional Research Institute Columbus Georgia
United States University of Texas Southwestern Medical Center; Internal Medicne Dallas Texas
United States Atlanta Center for Gastroenterology, PC Decatur Georgia
United States University of Florida College of Medicine Gainesville Florida
United States Gastro One Germantown Tennessee
United States Gastroenterology Associates of Western Michigan, P.L.C. Grand Rapids Michigan
United States Innovative Clinical Research Greenville South Carolina
United States Great Lakes Medical Research, LLC Harrisburg Pennsylvania
United States Baylor College of Medicine Houston Texas
United States Methodist Hospital Research Institute Houston Texas
United States University of Mississippi Medical Center Jackson Mississippi
United States Borland-Groover Clinic Jacksonville Florida
United States Vidant Medical Group, LLC DBA Vidant Multispeciality Clinic-Kinston Kinston North Carolina
United States University of California San Diego Medical Center La Jolla California
United States VA Long Beach Healthcare System Long Beach California
United States Gastroenterology Associates of Central Georgia Macon Georgia
United States University of Wisconsin Madison Wisconsin
United States Gastrointestinal Specialists of Georgia, PC Marietta Georgia
United States Great Lakes Gastroenterology Research, LLC Mentor Ohio
United States IMIC, Inc Miami Beach Florida
United States FQL Research, LLC Miramar Florida
United States Vanderbilt University Medical Center Nashville Tennessee
United States Concorde Medical Group New York New York
United States Lenox Hill Hospital New York New York
United States Weill Cornell Medical College-New York Presbyterian Hospital New York New York
United States Henry Ford Health System Novi Michigan
United States Southwest Gastroenterology Oak Lawn Illinois
United States Digestive Disease Specialists, Inc. Oklahoma City Oklahoma
United States McGuire Research Institute; Gastroenterology Richmond Virginia
United States Mayo Clinic - Rochester Rochester Minnesota
United States University of Utah School of Medicine Salt Lake City Utah
United States Wellness Clinical Research Center San Antonio Texas
United States Digestive Care Associates, A Medical Corporation San Carlos California
United States SDG Clinical Research San Diego California
United States Uni. of California at San Francisco; Dept Pediatric, Div. of Gastroenterology, Hepatology & Nutri San Francisco California
United States Digestive Disease Institute; Virginia Mason Medical Center Seattle Washington
United States Louisiana Research Center, LLC Shreveport Louisiana
United States Texas Digestive Disease Consultants - Southlake Southlake Texas
United States Advanced Clinical Research Spokane Idaho
United States Cotton-O'Neil Clinical Research Center, Digestive Health Topeka Kansas
United States Center for Digestive Health Troy Michigan
United States Digestive Health Specialists of Tyler Tyler Texas
United States Carle Foundation Hospital Urbana Illinois
United States Shafran Gastroenterology Center Winter Park Florida

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Croatia,  Czechia,  Estonia,  France,  Germany,  Hungary,  Israel,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  Netherlands,  New Zealand,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Switzerland,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Part 1: Number of Participants with Crohn's Disease Activity Index (CDAI) Remission Over Time Weeks 0, 12, 24, and every 12 weeks thereafter until study completion or early withdrawal, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Primary Part 1: Number of Participants with Clinical Remission Over Time Clinical remission is defined by a loose/soft stool frequency (SF) mean daily score =3 and an abdominal pain mean daily score =1 with no worsening in either subscore compared to baseline, averaged over 7 days prior to visit. Weeks 0, 12, 24, and every 12 weeks thereafter until study completion or early withdrawal, commercial availability of etrolizumab, or study termination, whichever is earlier (up to approximately 10 years)
Primary Part 1: Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 108 Week 108 (or at early withdrawal, if prior to Week 108)
Primary Part 1: Overall Number of Participants who Experienced at Least One Adverse Event by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Primary Part 1: Overall Number of Participants with Adverse Events Leading to Etrolizumab Discontinuation From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Primary Part 1: Overall Number of Participants who Experienced at Least One Infection-Related Adverse Event by Severity, According to NCI-CTCAE v4.0 From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Primary Part 1: Number of Infection-Related Adverse Events per Patient-Year From Week 0 until study completion or early withdrawal, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Primary Part 1: Overall Number of Participants who Experienced at Least One Infection-Related Serious Adverse Event From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Primary Part 1: Overall Number of Participants who Experienced at Least One Injection-Site Reaction by Severity, According to NCI-CTCAE v4.0 From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Primary Part 1: Overall Number of Participants who Develop Malignancies From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Primary Part 1: Number of Malignancies per Patient-Year From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Primary Part 1: Overall Number of Participants who Experienced at Least One Hypersensitivity Reaction by Severity, According to NCI-CTCAE v4.0 From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Primary Part 1: Number of Participants with Anti-Therapeutic Antibodies (ATAs) to Etrolizumab Weeks 0 and 12, and every 48 weeks thereafter until study completion or early withdrawal (up to approximately 10 years)
Primary Part 2: Number of Participants who Experienced at Least One Suspected or Confirmed Event of Progressive Multifocal Leukoencephalopathy (PML) From end of safety follow-up until completion of 92-week safety monitoring in Part 2 (up to 92 weeks)
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