Clinical trial NCT04232553: A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
Official title: A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients With Crohn's Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Crohn's Disease
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 778
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.


Eligibility criteria: Inclusion Criteria:

* Participants must have completed study I6T-MC-AMAG (NCT02891226) or study I6T-MC-AMAM (NCT03926130)
* If female, participant must meet the contraception requirements

Exclusion Criteria:

* Participants must not have developed a new condition, including cancer in the previous study (I6T-MC-AMAG or I6T-MC-AMAM) that would pose an unacceptable risk in the trial.
* Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either previous study.

Note: Participants with a history of active TB with documentation of treatment by the Centers for Disease Control (CDC) and/or World Health Organization (WHO) criteria prior to the originator study are not excluded from the study.

* Participants must not have a known hypersensitivity to any component of mirikizumab or have experienced acute systemic hypersensitivity event with previous study drug administration in the originating study that precludes mirikizumab therapy.
* Participation must not be pregnant, lactating, or planning to become pregnant while enrolled in the study or 16 weeks after receiving the last dose of study drug.

Primary outcomes:
measure: Percentage of Participants Achieving Endoscopic Response
timeFrame: Week 52
measure: Percentage of Participants Achieving Clinical Remission
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Participants Achieving Endoscopic Remission
timeFrame: Week 52
measure: Percentage of Participants Achieving Clinical Response
timeFrame: Week 52
measure: Change from Baseline in C-Reactive Protein
timeFrame: Baseline, Week 12
measure: Change from Baseline in Fecal Calprotectin
timeFrame: Baseline, Week 12
measure: Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ)
timeFrame: Baseline to Week 52
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Digestive Health Specialists
state: Alabama
city: Litchfield Park
country: United States
facility: Research Solutions of Arizona
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: Gilroy
country: United States
facility: Care Access - Gilroy
state: California
city: Huntington Beach
country: United States
facility: Newport Huntington Medical Group
state: California
city: Northridge
country: United States
facility: California Medical Research Associates
state: California
city: Bristol
country: United States
facility: Connecticut Clinical Research Institute
state: Connecticut
city: Clearwater
country: United States
facility: Gastroenterology Consultants of Clearwater
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc. (Clearwater)
state: Florida
city: Kissimmee
country: United States
facility: IHS Health Research
state: Florida
city: Miami
country: United States
facility: Ezy Medical Research
state: Florida
city: Orlando
country: United States
facility: Care Access - Orlando
state: Florida
city: Pensacola
country: United States
facility: Gastroenterology Associates of Pensacola, PA
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research
state: Florida
city: Tampa
country: United States
facility: USF Health
state: Florida
city: Tampa
country: United States
facility: Alliance Clinical Research of Tampa
state: Florida
city: Atlanta
country: United States
facility: Digestive Healthcare of Georgia
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia
state: Georgia
city: Idaho Falls
country: United States
facility: Grand Teton Research Group
state: Idaho
city: Evansville
country: United States
facility: Qualmedica Research, LLC
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health University Hospital
state: Indiana
city: Monroe
country: United States
facility: Delta Research Partners
state: Louisiana
city: Chevy Chase
country: United States
facility: Capital Digestive Care - Chevy Chase
state: Maryland
city: Glen Burnie
country: United States
facility: Woodholme Gastroenterology Associates - Glen Burnie
state: Maryland
city: Chesterfield
country: United States
facility: The Digestive Health Center of Michigan (DHCMI)
state: Michigan
city: Farmington Hills
country: United States
facility: Revive Research Institute, Inc.
state: Michigan
city: Plymouth
country: United States
facility: MNGI Digestive Health - Plymouth Endoscopy Center & Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University Medical School
state: Missouri
city: Las Vegas
country: United States
facility: Care Access - Las Vegas
state: Nevada
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Chapel Hill
country: United States
facility: Clinical & Translational Research Center (CTRC)
state: North Carolina
city: Greenville
country: United States
facility: Carolina Digestive Diseases and Endoscopy Center
state: North Carolina
city: Kinston
country: United States
facility: Care Access - Kinston
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio Gastroenterology
state: Ohio
city: Hilliard
country: United States
facility: Ohio State University
state: Ohio
city: Westlake
country: United States
facility: North Shore Gastroenterology & Endoscopy Centers
state: Ohio
city: Oklahoma City
country: United States
facility: The University of Oklahoma Health Sciences Center
state: Oklahoma
city: Providence
country: United States
facility: University Gastroenterology
state: Rhode Island
city: Orangeburg
country: United States
facility: Gastroenterology Associates of Orangeburg
state: South Carolina
city: Cordova
country: United States
facility: Gastroenterology Center Of The Midsouth
state: Tennessee
city: Bellaire
country: United States
facility: First Surgical Hospital
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine Medical Center
state: Texas
city: Lubbock
country: United States
facility: West Texas Digestive Disease
state: Texas
city: San Antonio
country: United States
facility: Southern Star Research Institute
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute
state: Texas
city: Ogden
country: United States
facility: Care Access - Ogden
state: Utah
city: Salt Lake City
country: United States
facility: Care Access - Salt Lake City
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
city: Williamsburg
country: United States
facility: Tidewater Physicians Multispecialty Group Clinical Research
state: Virginia
city: Bellevue
country: United States
facility: Washington Gastroenterology - Bellevue
state: Washington
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Tacoma
country: United States
facility: Washington Gastroenterology - Tacoma
state: Washington
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: DOM Centro de Reumatología
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Sydney
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Maroochydore
country: Australia
facility: Coastal Digestive Health
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck
state: Tirol
city: Vienna
country: Austria
facility: Universitaetsklinikum Allgemeines Krankenhaus Wien
state: Wien
city: Salzburg
country: Austria
facility: Uniklinikum Salzburg
city: Bonheiden
country: Belgium
facility: Imelda General Hospital
state: Antwerpen
city: Brussels
country: Belgium
facility: Université Libre de Bruxelles - Hôpital Erasme
state: Bruxelles-Capitale, Région De
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
city: Salvador
country: Brazil
facility: CLIAGEN Clínica de Atenção em Gastroenterologia, Especialidades e Nutrição
state: Bahia
city: Brasília
country: Brazil
facility: L2IP - Instituto de Pesquisas Clínicas
state: Distrito Federal
city: Brasília
country: Brazil
facility: Chronos Pesquisa Clínica
state: Distrito Federal
city: Belo Horizonte
country: Brazil
facility: Hospital Felicio Rocho
state: Minas Gerais
city: Caxias do sul
country: Brazil
facility: Fundação Universidade de Caxias do Sul (FUCS)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Núcleo de Pesquisa Clínica do Rio Grande do Sul
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: Rio Grande Do Sul
city: Botucatu
country: Brazil
facility: Faculdade de Medicina da UNESP
state: São Paulo
city: Campinas
country: Brazil
facility: Centro de Pesquisa Sao Lucas
state: São Paulo
city: Santo Andre
country: Brazil
facility: Praxis Pesquisa Medica
state: São Paulo
city: Santo André
country: Brazil
facility: Pesquisare Saude
state: São Paulo
city: Sao Bernardo do Campo
country: Brazil
facility: Centro Multidisciplinar de Estudos Clinicos
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Hospital Sírio Libanês
state: São Paulo
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clínica
city: São Paulo
country: Brazil
facility: Instituto de Assistência Médica ao Servidor Público Estadual - IAMSPE/HSPE-FMO Conhecer Centro de Oncolog -T
city: São Paulo
country: Brazil
facility: Clínica Hepatogastro JK
city: Edmonton
country: Canada
facility: Gastroenterology and internal medicine research institute
state: Alberta
city: Vancouver
country: Canada
facility: GIRI GI Research Institute - Vancouver
state: British Columbia
city: Kentville
country: Canada
facility: Private Practice - Dr. Bruce Musgrave
state: Nova Scotia
city: London
country: Canada
facility: Victoria Hospital
state: Ontario
city: North Bay
country: Canada
facility: Private Practice - Dr. Stephane M. Gauthier
state: Ontario
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Chongqing
country: China
facility: Chongqing General Hospital
state: Chongqing
city: Xiamen
country: China
facility: Zhongshan Hospital Affiliated to Xiamen University
state: Fujian
city: Foshan
country: China
facility: The First People's Hospital of Foshan
state: Guangdong
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical,Science & Technology
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
state: Jiangsu
city: Changzhou
country: China
facility: Changzhou No.2 People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital of Chinese Medicine
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Cheng Du
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated hospital of Zhejiang University school of medicine
state: Zhejiang
city: Wenzhou
country: China
facility: The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university
state: Zhejiang
city: Fuzhou
country: China
facility: The First Affiliated Hospital Of Fujian Medical University
city: Zagreb
country: Croatia
facility: Klinički bolnički centar Zagreb
state: Grad Zagreb
city: Osijek
country: Croatia
facility: Klinički bolnički centar Osijek
city: Brno
country: Czechia
facility: Vojenská Nemocnice Brno
state: Brno-město
city: Brno
country: Czechia
facility: Fakultni Nemocnice u sv. Anny v Brne
state: Brno-město
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK
state: Hradec Králové
city: Nachod
country: Czechia
facility: Oblastni nemocnice Nachod
state: Náchod
city: Olomouc
country: Czechia
facility: MUDr. Gregar, s.r.o.
state: Olomoucký Kraj
city: Ostrava
country: Czechia
facility: MUDr. Radka Koskova, s.r.o.
state: Ostrava Město
city: Prague
country: Czechia
facility: Synexus Czech
state: Praha 2
city: Prague
country: Czechia
facility: Fakultni Thomayerova nemocnice
state: Praha 4
city: Praha
country: Czechia
facility: Institut Klinicke a Experimentalni Mediciny
state: Praha 4
city: Praha
country: Czechia
facility: AXON Clinical
state: Praha 5
city: Praha
country: Czechia
facility: Fakultni nemocnice Motol
state: Praha 5
city: Prague
country: Czechia
facility: ISCARE klinické centrum
state: Praha 9
city: Zlín
country: Czechia
facility: Nemocnice Tomase Bati ve Zline
state: Zlínský Kraj
city: Olomouc
country: Czechia
facility: PreventaMed
city: Usti nad Labem
country: Czechia
facility: Masarykova Nemocnice V Usti Nad Labem
state: Ústí Nad Labem
city: Aalborg
country: Denmark
facility: Gastroenterologische Praxis Balsiger, Seibold & Partner
state: Nordjylland
city: Montpellier
country: France
facility: Chu Saint Eloi
state: Languedoc-Roussillon
city: Vandoeuvre lès Nancy
country: France
facility: Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
state: Meurthe-et-Moselle
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers
state: Vienne
city: Pforzheim
country: Germany
facility: Siloah St. Trudpert Klinikum
state: Baden-Württemberg
city: Wuerzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg
state: Bayern
city: Frankfurt am Main
country: Germany
facility: Synexus Clinical Research GmbH
state: Hessen
city: Lauterbach
country: Germany
facility: Siteworks GmbH - Lauterbach
state: Hessen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Bottrop
country: Germany
facility: Knappschaftskrankenhaus Bottrop
state: Nordrhein-Westfalen
city: Wipperfürth
country: Germany
facility: Gemeinschaftspraxis Jakobeit
state: Nordrhein-Westfalen
city: Halle (Saale)
country: Germany
facility: Studiengesellschaft BSF Unternehmergesellschaft
state: Sachsen-Anhalt
city: Leipzig
country: Germany
facility: Synexus Leipzig Clinical Research Centre
state: Sachsen
city: Kiel
country: Germany
facility: Allgemeine Innere Medizin I
state: Schleswig-Holstein
city: Oldenburg
country: Germany
facility: RED-Institut GmbH
state: Schleswig-Holstein
city: Nordhausen
country: Germany
facility: Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum
state: Thüringen
city: Gyula
country: Hungary
facility: Synexus Magyarország Kft
state: Békés
city: Gyöngyös
country: Hungary
facility: Bugát Pál Kórház
state: Heves
city: Tatabánya
country: Hungary
facility: Szent Borbala Korhaz
state: Komárom-Esztergom
city: Vác
country: Hungary
facility: Jávorszky Ödön Kórház
state: Pest
city: Szekszárd
country: Hungary
facility: CLINFAN Szolgáltató Kft
state: Tolna
city: Balatonfüred
country: Hungary
facility: DRC Gyógyszervizsgáló Központ
state: Veszprém
city: Budapest
country: Hungary
facility: Clinexpert Kft.
city: Budapest
country: Hungary
facility: SYNEXUS Magyarország Kft. Eü.
city: Budapest
country: Hungary
facility: Pannónia Magánorvosi Centrum
city: Békéscsaba
country: Hungary
facility: Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
city: Surat
country: India
facility: Gujarat Hospital - Gastro & Vascular Centre
state: Gujarat
city: Pune
country: India
facility: Grant Medical Foundation - Ruby Hall Clinic
state: Maharashtra
city: Ludhiana
country: India
facility: Dayanand Medical College and Hospital
state: Punjab
city: Jaipur
country: India
facility: SR Kalla Memorial Gastro & General Hospital
state: Rajasthan
city: Chennai
country: India
facility: Apollo Speciality Hospital - Teynampet
state: Tamil Nadu
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education & Research
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
state: HaDarom
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: HaMerkaz
city: Rehovot
country: Israel
facility: Kaplan Medical Center
state: HaMerkaz
city: Zerifin
country: Israel
facility: Yitzhak Shamir Medical Center
state: HaMerkaz
city: Nahariya
country: Israel
facility: Galilee Medical Center
state: HaTsafon
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
state: Yerushalayim
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
state: Lombardia
city: Milan
country: Italy
facility: IRCCS Policlinico San Donato
state: Milano
city: Rho
country: Italy
facility: Ospedale Di Circolo
state: Milano
city: Hirosaki
country: Japan
facility: National Hospital Organization Hirosaki General Medical Center
state: Aomori
city: Kashiwa
country: Japan
facility: Tsujinaka Hospital - Kashiwanoha
state: Chiba
city: Kitakyusyu-shi
country: Japan
facility: Kitakyushu Municipal Medical Center
state: Fukoka
city: Chikushino
country: Japan
facility: Fukuoka University Chikushi Hospital
state: Fukuoka
city: Kiryu
country: Japan
facility: Kiryu Kosei General Hospital
state: Gunma
city: Chuo-ku, Sapporo-shi
country: Japan
facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Tokushukai Sapporo Tokushukai Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo Higashi Tokushukai Hospital
state: Hokkaido
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine
state: Hyogo
city: Kasama
country: Japan
facility: Ibaraki Prefectural Central Hospital
state: Ibaraki
city: Kamakura
country: Japan
facility: Ofuna Central Hospital
state: Kanagawa
city: Tsu
country: Japan
facility: Mie University Hospital
state: Mie
city: Sendai
country: Japan
facility: Takagi Clinic - Sendai
state: Miyagi
city: Hamamatsu
country: Japan
facility: Matsuda Hospital
state: Shizuoka
city: Bunkyo
country: Japan
facility: Institute of Science Tokyo Hospital
state: Tokyo
city: Mitaka
country: Japan
facility: Kyorin University Hospital
state: Tokyo
city: Shinjyuku-ku
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
state: Tokyo
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kagoshima
country: Japan
facility: Sameshima Hospital
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Kyoto
country: Japan
facility: University Hospital,Kyoto Prefectural University of Medicine
city: Okayama
country: Japan
facility: Okayama Saiseikai Outpatient Center Hospital
city: Tokyo
country: Japan
facility: Tokyo Yamate Medical Center
city: Toyama
country: Japan
facility: Toyama Prefectural Central Hospital
city: Wonju
country: Korea, Republic of
facility: Yonsei University-Wonju Severance Christian Hospital
state: Kang-won-do
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Kyǒnggi-do
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Kyǒnggi-do
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital
state: Kyǒnggi-do
city: Gyeongsan-si
country: Korea, Republic of
facility: Yeungnam Univeristy Medical Center
state: Kyǒngsangbuk-do
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
state: Pusan-Kwangyǒkshi
city: Haeundae-gu
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
state: Pusan-Kwangyǒkshi
city: Dongjak-gu
country: Korea, Republic of
facility: Chungang University Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
state: Taegu-Kwangyǒkshi
city: Deagu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
state: Taegu-Kwangyǒkshi
city: Jung-gu
country: Korea, Republic of
facility: Kyungpook National University Hospital
state: Taegu-Kwangyǒkshi
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea, Daejeon St. Mary's Hospital
state: Taejǒn-Kwangyǒkshi
city: Riga
country: Latvia
facility: Pauls Stradins Clinical Univeristy Hospital
state: Rīga
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas
city: Monterrey
country: Mexico
facility: Christus Muguerza Hospital Sur
state: Nuevo León
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: Nuevo León
city: San Luis Potosi
country: Mexico
facility: Centro de Alta Especialidad en Reumatologia e Investigación del Potosi,S.C
state: San Luis Potosí
city: Chihuahua
country: Mexico
facility: Scientia Investigacion Clinica S.C.
city: Tilburg
country: Netherlands
facility: Elisabeth-TweeSteden Ziekenhuis
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie VUmc
state: Noord-Holland
city: Wroclaw
country: Poland
facility: Melita Medical
state: Dolnośląskie
city: Wroclaw
country: Poland
facility: Reumatop
state: Dolnośląskie
city: Wroclaw
country: Poland
facility: Synexus - Wroclaw
state: Dolnośląskie
city: Świdnica
country: Poland
facility: Dc-Med
state: Dolnośląskie
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne "Medis" Manermed
state: Kujawsko-pomorskie
city: Lublin
country: Poland
facility: ZOZ Gastromed
state: Lubelskie
city: Zamosc
country: Poland
facility: ETG Zamość
state: Lubelskie
city: Warsaw
country: Poland
facility: WIP Warsaw IBD Point Profesor Kierkus
state: Mazowieckie
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM
state: Mazowieckie
city: Krakow
country: Poland
facility: Topolowa Medicenter
state: Małopolskie
city: Wadowice
country: Poland
facility: NZOZ Formed
state: Małopolskie
city: Rzeszow
country: Poland
facility: Private Practice - Dr. Korczowski Bartosz
state: Podkarpackie
city: Rzeszow
country: Poland
facility: Centrum Medyczne MEDYK
state: Podkarpackie
city: Bialystok
country: Poland
facility: Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
state: Podlaskie
city: Gdansk
country: Poland
facility: Synexus Polska Gdansku
state: Pomorskie
city: Gdynia
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni
state: Pomorskie
city: Sopot
country: Poland
facility: Endoskopia Sp. z.o.o.
state: Pomorskie
city: Elblag
country: Poland
facility: NZOZ TwojeZdrowie
state: Warmińsko-mazurskie
city: Poznan
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Poznaniu
state: Wielkopolskie
city: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne
state: Zachodniopomorskie
city: Szczecin
country: Poland
facility: SONOMED Centrum Medyczne
state: Zachodniopomorskie
city: Czestochowa
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Czestochowie
state: Śląskie
city: Katowice
country: Poland
facility: Synexus Polska - Katowicach
state: Śląskie
city: Sosnowiec
country: Poland
facility: Kiepury Clinic
state: Śląskie
city: Bucharest
country: Romania
facility: Spitalul de Oncologie Monza
state: București
city: Bucharest
country: Romania
facility: Delta Health Care
state: București
city: Bucuresti
country: Romania
facility: S.C. Centrul Medical Medicum SRL
state: București
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina
state: București
city: Timisoara
country: Romania
facility: S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
state: Timiș
city: Constanța
country: Romania
facility: Gastromed S.R.L.
city: Barnaul
country: Russian Federation
facility: Poliklinika Agmu "Konsul'tativno-Diagnosticheskiy Tsentr"
state: Altayskiy Kray
city: Irkutsk
country: Russian Federation
facility: Scientific Centre of Reconstructive and Restorative Surgery
state: Irkutskaya Oblast'
city: Petrozavodsk
country: Russian Federation
facility: Karelia Republican Hospital V.A. Baranova
state: Kareliya, Respublika
city: Kemerovo
country: Russian Federation
facility: SIH Kemerovo Regional Clinical Hosptial
state: Kemerovskaya Oblast'
city: Moscow
country: Russian Federation
facility: Olla-Med
state: Moskva
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhny Novgorod Regional Hospital N.A. Semashko
state: Nizhegorodskaya Oblast'
city: Novosibirsk
country: Russian Federation
facility: LLC "Medicine Center SibNovoMed"
state: Novosibirskaya Oblast'
city: Novosibirsk
country: Russian Federation
facility: Research Institute of Physiology and Fundamental Medicine
state: Novosibirskaya Oblast'
city: Omsk
country: Russian Federation
facility: Clinic of Omsk State Medical University
state: Omskaya Oblast'
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical University
state: Rostovskaya Oblast'
city: Samara
country: Russian Federation
facility: NonState Healthcare Institution Central Clinical Hospital
state: Samarskaya Oblast'
city: Saint Petersburg
country: Russian Federation
facility: LLC Medical Center Reavita Med SPb
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: Balt Med Clinic
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg City Hospital of Saint Elizabeth
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: Scientific research center ECO-security
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg State Budgetary Healthcare Institution City Clinical Hospital No.31
state: Sankt-Peterburg
city: Saint-Petersburg
country: Russian Federation
facility: First Pavlov State Medical University of Saint Petersburg
state: Sankt-Peterburg
city: Ekaterinburg
country: Russian Federation
facility: LLC MA New Hospital
state: Sverdlovskaya Oblast'
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Zvezdara
state: Beograd
city: Belgrade
country: Serbia
facility: University Medical Center "Bezanijska kosa"
state: Beograd
city: Zrenjanin
country: Serbia
facility: General Hospital "Djordje Joanovic"
state: Vojvodina
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
state: Banskobystrický Kraj
city: Bratislava
country: Slovakia
facility: Cliniq s.r.o.
state: Bratislavský Kraj
city: Nové Zámky
country: Slovakia
facility: Gastromedic
state: Nitriansky Kraj
city: Presov
country: Slovakia
facility: Gastro LM
state: Prešovský Kraj
city: Vranov N. Toplou
country: Slovakia
facility: Endomed, s.r.o.
state: Prešovský Kraj
city: Bern
country: Switzerland
facility: Gastroenterologische Praxis Balsiger, Seibold & Partner
state: Berne
city: St.Gallen
country: Switzerland
facility: Cantonal Hospital St.Gallen
state: Sankt Gallen
city: Berne
country: Switzerland
facility: Inselspital Bern
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University
state: Eskişehir
city: Istanbul- Fatih
country: Turkey
facility: Istanbul Universitesi Cerrahpasa
state: İstanbul
city: Balcova
country: Turkey
facility: Dokuz Eylül Üniversitesi
state: İzmir
city: Izmit
country: Turkey
facility: Kocaeli University Medical Faculty Hospital
state: Kocaeli
city: Ankara
country: Turkey
facility: Ankara City Hospital
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri
city: Ankara
country: Turkey
facility: Gazi University Health Research and Application Center Gazi Hospital
city: Antalya
country: Turkey
facility: Antalya Egitim ve Arastırma Hastanesi
city: Bursa
country: Turkey
facility: Uludag Universitesi
city: Edirne
country: Turkey
facility: Trakya University
city: Hatay
country: Turkey
facility: Mustafa Kemal Universitesi
city: Istanbul
country: Turkey
facility: Medicana Kadiköy Hastanesi
city: Istanbul
country: Turkey
facility: Acbadem Kozyatagi Hospital
city: Mersin
country: Turkey
facility: Mersin University
city: Dnipro
country: Ukraine
facility: Medical Center Family Medicine Clinic
state: Dnipropetrovska Oblast
city: Ivano-Frankivsk
country: Ukraine
facility: Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council"
state: Ivano-Frankivska Oblast
city: Kharkiv
country: Ukraine
facility: City Clinical Hospital No. 2
state: Kharkivska Oblast
city: Kyiv
country: Ukraine
facility: Medbud Clinic
state: Kyivska Oblast
city: Lviv
country: Ukraine
facility: University Hospital branch of Danylo Halytsky Lviv National Medical University (UH DHLNMU)
state: Lvivska Oblast
city: Odesa
country: Ukraine
facility: Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council
state: Odeska Oblast
city: Vinnytsia
country: Ukraine
facility: Medical Clinical Investigational Center of Medical Center Health Clinic
state: Vinnytska Oblast
city: Vinnytsya
country: Ukraine
facility: City Clinical Hospital #1, Vinnitsya National Medical University
state: Vinnytska Oblast
city: Vinnytsya
country: Ukraine
facility: Municipal Nonprofit Enterprise "Vinnytsia Regional Clinical Hospital n.a. M. I. Pyrohov of Vinnytsia Regio -T
state: Vinnytska Oblast
city: Vinnytsya
country: Ukraine
facility: VNMU
state: Vinnytska Oblast
city: Uzhgorod
country: Ukraine
facility: Transcarpathian Regional Hospital im.Andriya Novak
state: Zakarpatska Oblast
city: Zaporizhia
country: Ukraine
facility: Communal Non-profit Enterprise "City Hospital #6" of Zaporizhzhia City Council
state: Zaporizka Oblast
city: Zaporizhzhia
country: Ukraine
facility: Diacenter
state: Zaporizka Oblast
city: Chernivtsi
country: Ukraine
facility: Chernivtsi Regional Clinical Hospital
city: Kyiv
country: Ukraine
facility: Medical Center Ok!Clinic+
city: Kyiv
country: Ukraine
facility: Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrainian Ra -T
city: Kyiv
country: Ukraine
facility: Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
city: Kyiv
country: Ukraine
facility: Municipal non-profit enterprise of Kyiv Regional Council "Kyiv Regional Center for Rehabilitation Medicine"
city: Kyiv
country: Ukraine
facility: Municipal Nonprofit Enterprise of Kyiv Region Council "Kyiv Regional Clinical Hospital"
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: Cambridgeshire
city: London
country: United Kingdom
facility: Whipps Cross University Hospital
state: England
city: Cardiff
country: United Kingdom
facility: Synexus Wales Clinical Research Centre
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM -5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: