A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease

Crohn's Disease Clinical Trial

— FORTIFY  

Official title:

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03105102
• Other study ID #: M16-000
• Secondary ID: 2016-003191-50
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 9, 2018
• Est. completion date: May 14, 2026

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study consists of 4 sub-studies, as follows:

• Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to intravenous risankizumab induction treatment in Study M16-006 or Study M15-991;

• Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991;

• Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2, another AbbVie risankizumab Crohn's disease study, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab;

• Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and pharmacokinetics of risankizumab administered via OBI in participants who are receiving maintenance treatment with risankizumab.

• OL CTE to ensure uninterrupted care in accordance with local regulations until risankizumab is commercially available for participants who completed Sub-study 3, Sub-study 4.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1336
• Est. completion date: May 14, 2026
• Est. primary completion date: May 14, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria:

• Participants who have entered and completed Study M16-006 or Study M15-991 or other AbbVie risankizumab Crohn's disease study.

• Participants have completed the study M16-006 or M15-991 and have achieved clinical response.

• Sub-Study 4:

• Participants receiving maintenance treatment in Sub-study 3 and willing to comply with the requirements of Sub-study 4, including self-administration of sub-cutaneous injections using the on-body injector (OBI).

• Participant has received at least 16 weeks of stable dosing with risankizumab in Sub-study 3 (i.e., no rescue within 16 weeks and participant has surpassed the 72-week mark).

Exclusion Criteria:

• Participants should not be enrolled in Study M16-000 with high grade colonic dysplasia or colon cancer identified during Study M15-991, Study M16-006 or another AbbVie risankizumab Crohn's disease study if the final endoscopy was performed prior to enter Study M16-000 OR is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.

• Participant who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of Chinese hamster ovary (CHO), OR had an adverse event (AE) during Studies M16-006, M15-991 or another AbbVie risankizumab Crohn's disease study that in the Investigator's judgment makes the participant unsuitable for this study.

• Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-006, M15-991 or another AbbVie risankizumab Crohn's disease study.

• Confirmed positive urine pregnancy test at the Final Visit of Study M16-006, Study M15-991 or another AbbVie risankizumab Crohn's disease study.

• Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.

• Any active or chronic recurring infections based on the Investigator's assessment makes the participant an unsuitable candidate for the study.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Placebo for Risankizumab SC
Placebo for Risankizumab SC Subcutaneous (SC) Injection
• Risankizumab IV
Risankizumab IV Intravenous (IV) infusion
• Placebo for Risankizumab IV
Placebo for Risankizumab IV Intravenous (IV) infusion
• Risankizumab SC
Risankizumab SC Subcutaneous (SC) injection
• Risankizumab On-Body Injector (OBI)
Subcutaneous (SC) injection; on-body injector (OBI)

Locations

Country	Name	City	State
Argentina	Cemic /Id# 168078	Ciudad Autonoma de Buenos Aire	Ciudad Autonoma De Buenos Aires
Argentina	Hospital Britanico de Buenos Aires /ID# 168077	Ciudad Autonoma de Buenos Aire	Ciudad Autonoma De Buenos Aires
Argentina	Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 168076	Cordoba
Argentina	Hospital Provincial del Centenario /ID# 170886	Rosario	Santa Fe
Australia	Emeritus Research /ID# 213512	Camberwell	Victoria
Australia	Lyell McEwin Hospital /ID# 212215	Elizabeth Vale	South Australia
Australia	Mater Misericordiae Limited /ID# 167220	South Brisbane	Queensland
Australia	Griffith University /ID# 212635	Southport	Queensland
Austria	Medizinische Universitaet Graz /ID# 158140	Graz	Steiermark
Austria	Universitaetsklinikum St. Poelten /ID# 166424	Sankt Poelten	Niederoesterreich
Austria	Krankenhaus der Barmherzigen Brueder Wien /ID# 212060	Vienna	Wien
Austria	Medizinische Universitaet Wien /ID# 158141	Vienna	Wien
Belarus	Vitebsk Regional Advanced Clin /ID# 206778	???????
Belarus	Gomel Regional Clinical Hospital /ID# 205112	Gomel
Belarus	Grodno city clinical hospital #2 /ID# 205113	Grodno
Belgium	Universite Libre de Bruxelles - Hopital Erasme /ID# 157408	Anderlecht	Bruxelles-Capitale
Belgium	Imelda Ziekenhuis /ID# 157403	Bonheiden
Belgium	AZ Maria Middelares /ID# 213532	Gent
Belgium	UZ Gent /ID# 157405	Gent	Oost-Vlaanderen
Belgium	AZ Groeninge /ID# 211513	Kortrijk
Belgium	Universitair Ziekenhuis Leuven /ID# 157407	Leuven	Vlaams-Brabant
Belgium	CHU de Liege /ID# 157409	Liege
Belgium	Groupe Sante CHC - Clinique du MontLegia /ID# 157404	Liege
Belgium	AZ Sint-Maarten /ID# 212876	Mechelen	Antwerpen
Belgium	ZNA - Jan Palfijn /ID# 212877	Merksem
Belgium	AZ-Delta /ID# 157402	Roeselare	West-Vlaanderen
Belgium	Cliniques Universitaires UCL Saint-Luc /ID# 157406	Woluwe-Saint-Lambert	Bruxelles-Capitale
Belgium	Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 157412	Yvoir	Namur
Bosnia and Herzegovina	Klinicki centar Banja Luka /ID# 164513	Banja Luka
Bosnia and Herzegovina	Clinical Center University of Sarajevo /ID# 165139	Sarajevo
Bulgaria	UMHAT Dr Georgi Stranski EAD /ID# 203976	Pleven
Bulgaria	UMHAT Kaspela EOOD /ID# 165700	Plovdiv
Bulgaria	2nd Mhat /ID# 165702	Sofia
Bulgaria	Duplicate_UMHAT Tsaritsa Joanna - ISUL /ID# 211242	Sofia
Bulgaria	Tokuda Hospital Sofia /ID# 165701	Sofia
Bulgaria	UMHAT Sveti Ivan Rilski /ID# 204815	Sofia
Bulgaria	MHAT Trakia /ID# 201668	Stara Zagora
Canada	University of Calgary /ID# 157155	Calgary	Alberta
Canada	Allen Whey Khye Lim Professional Corporation /ID# 169763	Edmonton	Alberta
Canada	Covenant Health /ID# 161632	Edmonton	Alberta
Canada	University of Alberta Hospital /ID# 157099	Edmonton	Alberta
Canada	CISSS de la Monteregie Centre - Hopital Charles Le Moyne /ID# 161630	Greenfield Park
Canada	IWK Health Center /ID# 165905	Halifax	Nova Scotia
Canada	QEII - Health Sciences Centre /ID# 157088	Halifax	Nova Scotia
Canada	Hamilton Health Sciences - McMaster University Medical Centre /ID# 157184	Hamilton	Ontario
Canada	Hotel Dieu de Levis /ID# 214377	Lévis	Quebec
Canada	London Health Sciences Center- University Hospital /ID# 157161	London	Ontario
Canada	CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 159056	Montreal	Quebec
Canada	Montreal General Hospital- McGill University Health Center /ID# 157085	Montreal
Canada	Fraser Clinical Trials Inc /ID# 159055	New Westminster	British Columbia
Canada	Scott Shulman Medicine Professional Corporation /ID# 165906	North Bay	Ontario
Canada	Medicor Research Inc /ID# 157150	Sudbury	Ontario
Canada	Mount Sinai Hospital /ID# 169764	Toronto	Ontario
Canada	GIRI Gastrointestinal Research Institute /ID# 157096	Vancouver	British Columbia
Canada	Toronto Digestive Disease Associates, Inc. /ID# 157158	Vaughan	Ontario
Canada	Percuro Clinical Research, Ltd /ID# 161631	Victoria	British Columbia
Chile	Hospital Guillermo Grant Benavente de Concepción /ID# 210760	Concepción
Chile	Complejo Asistencial Dr. Sotero del Rio /ID# 169384	Santiago	Region Metropolitana De Santiago
Chile	Servicio de Salud Occidente Hospital San Juan de Dios /ID# 171122	Santiago	Region Metropolitana Santiago
Chile	Hospital Las Higueras /ID# 167092	Talcahuano
China	The Second Xiangya Hospital of Central South University /ID# 211700	Changsha
China	West China Hospital, Sichuan University /ID# 210890	Chengdu	Sichuan
China	Guangdong Provincial People's Hospital /ID# 212949	Guangzhou	Guangdong
China	The Sixth Affiliated Hosp Sun /ID# 210784	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 210625	Hangzhou	Zhejiang
China	The second affiliated hospital of Zhejiang University school of medicine /ID# 210724	Hangzhou	Zhejiang
China	Jinhua Municipal Central Hospital /ID# 215628	Jinhua	Zhejiang
China	The First Affiliated Hospital of Nanchang University /ID# 211036	Nanchang	Jiangxi
China	Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 210705	Shanghai	Shanghai
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210840	Shanghai	Shanghai
China	Shanghai East Hospital /ID# 212684	Shanghai	Shanghai
China	The Second Hospital of Hebei Medical University /ID# 212738	Shijiazhuang	Hebei
China	Tianjin Medical University General Hospital /ID# 210926	Tianjin
China	Renmin Hospital of Wuhan University /ID# 214874	Wuhan	Hubei
China	Tongji Hospital Tongji Medical College of HUST /ID# 210858	Wuhan	Hubei
China	Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 211039	Wuhan	Hubei
Colombia	Hospital Univ San Ignacio /ID# 158734	Bogota	Cundinamarca
Colombia	Hospital Universitario San Vic /ID# 171486	Medellin
Colombia	Instituto de Coloproctologia /ID# 158743	Medellin	Antioquia
Colombia	Hospital Pablo Tobón Uribe /ID# 158730	Medellín
Croatia	Poliklinika Borzan d.o.o. /ID# 157559	Osijek
Croatia	Klinicki Bolnicki Centar (KBC) Split /ID# 157562	Split	Splitsko-dalmatinska Zupanija
Croatia	Zadar General Hospital /ID# 157563	Zadar
Croatia	Klinicka bolnica Dubrava Zagreb /ID# 157560	Zagreb	Grad Zagreb
Croatia	Klinicki bolnicki centar Sestre milosrdnice /ID# 157728	Zagreb	Grad Zagreb
Croatia	Klinicki bolnicki centar Zagreb /ID# 157561	Zagreb	Grad Zagreb
Czechia	Hepato-Gastroenterologie HK, s.r.o. /ID# 163225	Hradec Kralove
Czechia	Nemocnice Pardubickeho kraje, a.s. /ID# 163226	Pardubice
Czechia	Iscare Klinické Centrum /ID# 225794	Prague	Praha 9
Czechia	Duplicate_Institut klinicke a experimentalni mediciny (IKEM) /ID# 165465	Prague 4	Praha 4
Czechia	Axon Clinical, s.r.o. /ID# 163223	Praha
Czechia	Fakultni Thomayerova nemocnice /ID# 162941	Praha
Czechia	Nemocnice Horovice - NH Hospital a.s /ID# 211077	Praha
Czechia	Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 211306	Praha
Czechia	ResTrial s.r.o. /ID# 211078	Praha
Denmark	Aarhus Universitetshospital - Skejby /ID# 155664	Aarhus	Midtjylland
Denmark	Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 155530	Hvidovre	Hovedstaden
Denmark	Sygehusenheden Nyborg - OUH /ID# 161525	Nyborg	Syddanmark
Denmark	Odense University Hospital /ID# 155531	Odense	Syddanmark
Denmark	Roskilde Sygehus /ID# 155532	Roskilde	Sjælland
Egypt	Zagazig University Hospitals /ID# 164539	Al Sharqia
Egypt	Alexandria University /ID# 157187	Alexandria
Egypt	Alexandria University /ID# 164540	Alexandria
Egypt	Clinical Research Center, Faculty of Medicine, Cairo university /ID# 157175	Cairo
Egypt	Duplicate_Internal Medicine Department, Faculty of Medicine, AinShams University /ID# 157506	Cairo
Egypt	National Hepatology and Tropical Medicine Research Institute /ID# 157874	Cairo
Estonia	North Estonia Medical Centre /ID# 164326	Mustamäe Linnaosa	Harjumaa
Estonia	East Tallinn Central Hospital /ID# 157074	Tallinn
Estonia	West Tallinn Central Hospital /ID# 157075	Tallinn
France	CHU Amiens-Picardie Site Sud /ID# 165058	Amiens CEDEX 1	Somme
France	Hopital Beaujon /ID# 166284	Clichy	Ile-de-France
France	Duplicate_CHU Grenoble - Hopital Michallon /ID# 212834	La Tronche	Isere
France	CHRU Lille - Hopital Claude Huriez /ID# 162559	Lille	Nord
France	CHU Montpellier - Hopital Saint Eloi /ID# 215147	Montpellier Cedex 5	Herault
France	Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 249858	Neuilly Sur Seine	Ile-de-France
France	Chu de Nice-Hopital Larchet Ii /Id# 162557	Nice	Alpes-Maritimes
France	Centre Hospitalier Universitaire de Bordeaux /ID# 162558	Pessac CEDEX	Gironde
France	HCL - Hopital Lyon Sud /ID# 162560	Pierre Benite CEDEX	Rhone
France	CHRU Pontchaillou /ID# 213209	Rennes
France	Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 162562	St-Priest-en-Jarez
France	CHRU Nancy - Hopitaux de Brabois /ID# 162561	Vandoeuvre-les-Nancy	Meurthe-et-Moselle
Germany	DRK Kliniken Berlin Westend /ID# 166151	Berlin
Germany	Duplicate_Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212220	Berlin
Germany	Duplicate_Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212894	Berlin
Germany	Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 211974	Berlin
Germany	MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159350	Berlin
Germany	Krankenhaus Waldfriede /ID# 212727	Berlin-Zehlendorf
Germany	Stadtisches Klinikum Braunschweig /ID# 163680	Braunschweig
Germany	Evangelisches Krankenhaus Kalk /ID# 212726	Cologne	Nordrhein-Westfalen
Germany	Medizinisches Versorgunszentrum Dachau /ID# 211555	Dachau
Germany	Universitaetsklinikum Erlangen /ID# 159343	Erlangen	Bayern
Germany	Duplicate_Agaplesion Markus Krankenhaus /ID# 159345	Frankfurt am Main	Hessen
Germany	Universitaetsklinikum Frankfurt /ID# 212979	Frankfurt am Main	Hessen
Germany	Universitaetsklinikum Freiburg /ID# 162030	Freiburg	Baden-Wuerttemberg
Germany	Praxiszentrum fuer Gastroenterologie /ID# 211966	Grevenbroich	Nordrhein-Westfalen
Germany	Medizinische Hochschule Hannover /ID# 162032	Hannover
Germany	Praxis fuer Gastroenterologie /ID# 166150	Heidelberg	Baden-Wuerttemberg
Germany	Universitaetsklinikum Jena /ID# 159351	Jena	Thueringen
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159349	Kiel	Schleswig-Holstein
Germany	Universitaetsklinikum Koeln /ID# 164989	Köln	Nordrhein-Westfalen
Germany	Eugastro /ID# 212078	Leipzig	Sachsen
Germany	Klinikum Lueneburg /ID# 163678	Lueneburg
Germany	Universitaetsklinikum Magdeburg /ID# 211843	Magdeburg
Germany	Universitatsklinikum Mannheim /ID# 162031	Mannheim	Baden-Wuerttemberg
Germany	Gastroenterologische Gemeinschaftspraxis Minden /ID# 162029	Minden
Germany	Universitaetsklinikum Muenster /ID# 159344	Muenster	Nordrhein-Westfalen
Germany	Universitaetsklinikum Regensburg /ID# 163813	Regensburg
Germany	Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 210528	Saarbrücken	Saarland
Germany	Universitaetsklinikum Ulm /ID# 164990	Ulm	Baden-Wuerttemberg
Greece	General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157423	Athens
Greece	General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170914	Athens	Attiki
Greece	University General Hospital of Heraklion PA.G.N.I /ID# 157422	Heraklion	Kriti
Greece	University General Hospital of Ioannina /ID# 157420	Ioannina
Greece	General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 157424	Nikaia
Greece	Tzaneio general hospital of Piraeus /ID# 206443	Piraeus	Attiki
Greece	Theageneio Anticancer Hospital /ID# 163897	Thessaloniki
Hong Kong	Queen Mary Hospital /ID# 163923	Hong Kong
Hong Kong	Tuen Mun Hospital /ID# 163905	Hong Kong
Ireland	Duplicate_Beaumont Hospital /ID# 157543	Beaumont	Dublin
Ireland	St Vincent's University Hospital /ID# 157540	Elm Park	Dublin
Ireland	University Hospital Galway /ID# 157541	Galway
Israel	The Edith Wolfson Medical Center /ID# 217331	Ashkelon	HaDarom
Israel	Soroka University Medical Center /ID# 157794	Be'er Sheva	HaDarom
Israel	Duplicate_Rambam Medical Center /ID# 171067	Haifa
Israel	Hadassah Medical Center-Hebrew University /ID# 165914	Jerusalem	Yerushalayim
Israel	Shaare Zedek Medical Center /ID# 163541	Jerusalem	Yerushalayim
Israel	Shaare Zedek Medical Center /ID# 171068	Jerusalem	Yerushalayim
Israel	The Chaim Sheba Medical Center /ID# 157793	Ramat Gan	Tel-Aviv
Israel	The Chaim Sheba Medical Center /ID# 171069	Ramat Gan	Tel-Aviv
Israel	Tel Aviv Sourasky Medical Center /ID# 157792	Tel Aviv	Tel-Aviv
Italy	IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 155643	Bologna
Italy	A.O. Per L'Emergenza Cannizzaro /ID# 161300	Catania
Italy	University of Catanzaro /ID# 212016	Catanzaro	Calabria
Italy	Duplicate_Azienda Ospedaliera Univ. Meyer /ID# 167992	Florence	Toscana
Italy	Ospedale Policlinico San Martino /ID# 162439	Genoa	Genova
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 155641	Milan
Italy	ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 155639	Milano
Italy	Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 212028	Modena
Italy	IRCCS Ospedale Sacro Cuore Don Calabria /ID# 161299	Negrar	Verona
Italy	A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 155645	Palermo
Italy	Duplicate_Fondazione IRCCS Policlinico S. Matteo /ID# 212031	Pavia
Italy	ASST Rhodense/Presidio Ospedaliero di Rho /ID# 212227	Rho	Milano
Italy	Azienda Ospedaliera San Camillo Forlanini /ID# 155644	Rome	Roma
Italy	Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 158022	Rome	Roma
Italy	Duplicate_Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 166912	Rome	Roma
Italy	Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 162438	Rome	Roma
Italy	Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 155640	Rome	Roma
Italy	Istituto Clinico Humanitas /ID# 155642	Rozzano	Milano
Italy	Duplicate_AOU Ospendali Riuniti di Ancona /ID# 162436	Torrette	Ancona
Japan	Tokatsu Tsujinaka Hospital /ID# 163352	Abiko-shi	Chiba
Japan	Asahikawa Medical University Hospital /ID# 162848	Asahikawa-shi	Hokkaido
Japan	Tokyo Medical And Dental University Hospital /ID# 160095	Bunkyo-ku	Tokyo
Japan	Chiba University Hospital /ID# 217533	Chiba-shi	Chiba
Japan	Fukuoka University Hospital /ID# 217793	Fukuoka-shi	Fukuoka
Japan	NHO Fukuyama Medical Center /ID# 163577	Fukuyama-shi	Hiroshima
Japan	Tokai University Hachioji Hospital /ID# 160098	Hachioji-shi	Tokyo
Japan	Hamamatsu University Hospital /ID# 205690	Hamamatsu-shi	Shizuoka
Japan	National Hospital Organization Mito Medical Center /ID# 160092	Higashi Ibaraki-gun	Ibaraki
Japan	Hiroshima University Hospital /ID# 160109	Hiroshima-shi	Hiroshima
Japan	Gokeikai Ofuna Chuo Hospital /ID# 171066	Kamakura-shi	Kanagawa
Japan	Kanazawa University Hospital /ID# 202258	Kanazawa-shi	Ishikawa
Japan	The Jikei University Kashiwa Hospital /ID# 200030	Kashiwa-shi	Chiba
Japan	Tsujinaka Hospital Kashiwanoha /ID# 213848	Kashiwa-shi	Chiba
Japan	Saitama Medical Center /ID# 160093	Kawagoe-shi	Saitama
Japan	Yamanashi Prefectural Central Hospital /ID# 160094	Kofu-shi	Yamanashi
Japan	Kurume University Hospital /ID# 160106	Kurume-shi	Fukuoka
Japan	Kitasato University Kitasato Institute Hospital /ID# 160105	Minato-ku	Tokyo
Japan	The Jikei University Hospital /ID# 163209	Minato-ku	Tokyo
Japan	Kyorin University - Mitaka Campus /ID# 160114	Mitaka
Japan	Aichi Medical University /ID# 160097	Nagakute	Aichi
Japan	Nagoya City University Hospital /ID# 160100	Nagoya shi	Aichi
Japan	Daido Clinic /ID# 211476	Nagoya-shi	Aichi
Japan	Nagoya University Hospital /ID# 160116	Nagoya-shi	Aichi
Japan	Hyogo Medical University Hospital /ID# 160107	Nishinomiya-shi	Hyogo
Japan	Nishinomiya Municipal Central Hospital /ID# 210103	Nishinomiya-shi	Hyogo
Japan	Osaka Metropolitan University Hospital /ID# 160117	Osaka-shi	Osaka
Japan	Shiga University of Medical Science Hospital /ID# 164025	Otsu-shi	Shiga
Japan	Kitasato University Hospital /ID# 171065	Sagamihara-shi	Kanagawa
Japan	Tokitokai Tokito clinic /ID# 160110	Saitama-shi	Saitama
Japan	Toho University Sakura Medical Center /ID# 160099	Sakura-shi	Chiba
Japan	Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 160096	Sapporo-shi	Hokkaido
Japan	Sapporo Medical University Hospital /ID# 163056	Sapporo-shi	Hokkaido
Japan	Sapporo Tokushukai Hospital /ID# 213492	Sapporo-shi	Hokkaido
Japan	Tohoku Rosai Hospital /ID# 163229	Sendai-shi	Miyagi
Japan	Tohoku University Hospital /ID# 162847	Sendai-shi	Miyagi
Japan	Tokyo Women's Medical University Hospital /ID# 205974	Shinjuku-ku	Tokyo
Japan	NHO Shizuoka Medical Center /ID# 163057	Sunto-gun	Shizuoka
Japan	Duplicate_Fujita Health University Hospital /ID# 163234	Toyoake-shi	Aichi
Japan	Mie University Hospital /ID# 203640	Tsu-shi	Mie
Japan	Wakayama Medical University Hospital /ID# 202561	Wakayama-shi	Wakayama
Japan	Yamagata University Hospital /ID# 200159	Yamagata-shi	Yamagata
Japan	Yokkaichi Hazu Medical Center /ID# 163764	Yokkaichi-shi	Mie
Japan	Yokohama City University Medical Center /ID# 163907	Yokohama shi	Kanagawa
Japan	Yokohama Municipal Citizen's Hospital /ID# 207161	Yokohama-shi	Kanagawa
Korea, Republic of	Dong-A University Medical Center /ID# 158699	Busan	Gyeongsangnamdo
Korea, Republic of	Inje University Haeundae Hospital /ID# 202518	Busan
Korea, Republic of	Pusan National University Hospital /ID# 158695	Busan
Korea, Republic of	Yeungnam University Medical Center /ID# 158691	Daegu
Korea, Republic of	The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 213554	Daejeon	Daejeon Gwang Yeogsi
Korea, Republic of	Hanyang University Guri Hospital /ID# 158690	Guri-si	Gyeonggido
Korea, Republic of	Duplicate_CHA University Bundang Medical Center /ID# 158698	Seongnam si	Gyeonggido
Korea, Republic of	Asan Medical Center /ID# 158696	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Kangbuk Samsung Hospital /ID# 158694	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Samsung Medical Center /ID# 158692	Seoul
Korea, Republic of	Yonsei University Health System Severance Hospital /ID# 158689	Seoul	Seoul Teugbyeolsi
Korea, Republic of	The Catholic University Of Korea St. Vincent's Hospital /ID# 158693	Suwon	Gyeonggido
Latvia	Duplicate_Digestive Disease Center Gastro /ID# 163107	Riga
Latvia	Pauls Stradins Clinical University Hospital /ID# 159612	Riga	Riga
Latvia	VCA Polyclinic Aura /ID# 159611	Riga
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 162583	Kaunas
Lithuania	Vilnius University Hospital Santaros Klinikos /ID# 162514	Vilnius
Malaysia	Queen Elizabeth Hospital /ID# 160664	Division Pantai Barat Utara	Sabah
Malaysia	Universiti Sains Malaysia /ID# 160666	Kelantan
Malaysia	Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 201363	Kuala Lumpur	Selangor
Mexico	JM Research SC /ID# 170729	Cuernavaca	Morelos
Mexico	Health Pharma Professional Research S.A de C.V /ID# 170730	Del. Benito Juárez
Mexico	Unidad de Atencion Medica e Investigacion en Salud /ID# 170732	Merida	Yucatan
Mexico	Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V. /ID# 170734	Zapopan	Jalisco
Netherlands	Amsterdam UMC, locatie AMC /ID# 157956	Amsterdam	Noord-Holland
Netherlands	Elisabeth Tweesteden Ziekenhuis /ID# 163632	Tilburg
New Zealand	Christchurch Hospital /ID# 167224	Christchurch	Canterbury
New Zealand	Dunedin Hospital /ID# 167227	Otago
New Zealand	Aotearoa Clinical Trials /ID# 167226	Papatoetoe	Auckland
New Zealand	Duplicate_Wellington Hospital (Capital and Coast District Health Board) /ID# 167225	Wellington
Norway	Helse More og Romsdal HF, Alesund sjukehus /ID# 212810	Ålesund
Norway	Duplicate_Vestre viken - Baerum Sykehus /ID# 212996	Gjettum	Akershus
Norway	Sykehuset Levanger Helse NT /ID# 201669	Levanger
Norway	Akershus Universitetssykehus /ID# 169379	Nordbyhagen	Akershus
Poland	Centrum Medyczne LukaMed Joanna Luka /ID# 212478	Chojnice	Pomorskie
Poland	Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego w Lodzi /ID# 212477	Lodz	Lodzkie
Poland	1 Wojskowy Szpital Kliniczny Z Poliklinika /Id# 210940	Lublin	Lubelskie
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie /ID# 210941	Lublin	Lubelskie
Poland	Wojewodzki Szpital Specjalistyczny /ID# 212474	Olsztyn	Warminsko-mazurskie
Poland	Solumed Centrum Medyczne /ID# 163569	Poznan	Wielkopolskie
Poland	Centrum Medyczne Medyk /ID# 212891	Rzeszow	Podkarpackie
Poland	Gastromed Sp. z o.o /ID# 212476	Torun	Kujawsko-pomorskie
Poland	H-T Centrum Medyczne Endoterapia /ID# 212475	Tychy	Slaskie
Poland	Centrum Zdrowia MDM /ID# 163570	Warszawa	Mazowieckie
Poland	Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 213580	Warszawa	Mazowieckie
Poland	NZOZ Vivamed Jadwiga Miecz /ID# 202800	Warszawa	Mazowieckie
Poland	Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 163582	Warszawa	Mazowieckie
Poland	Planetmed Sp. z o.o. /ID# 202799	Wroclaw	Dolnoslaskie
Poland	Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclaw /ID# 212601	Wroclaw
Portugal	Duplicate_Hospital Garcia de Orta, EPE /ID# 160745	Almada	Setubal
Portugal	Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 160713	Faro
Portugal	Duplicate_Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 160737	Guimaraes	Braga
Portugal	Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 167751	Lisboa
Portugal	Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 160692	Lisboa
Portugal	Centro Hospitalar de Lisboa Central /ID# 160673	Lisbon
Portugal	Hospital de Loures, E.P.E /ID# 207759	Loures
Portugal	Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 167752	Portimão	Faro
Portugal	Centro Hospitalar Universitario de Sao Joao, EPE /ID# 160693	Porto
Portugal	Centro Hospitalar de Entre Douro e Vouga /ID# 160672	Santa Maria Da Feira	Porto
Portugal	Centro Hosp de Tondela-Viseu /ID# 160699	Viseu
Romania	Fundeni Clinical Institute /ID# 170899	Bucharest
Romania	Tvm Med Serv Srl /Id# 170902	Cluj
Romania	Cabinet Particular Policlinic Algomed /ID# 170900	Timi?oara
Romania	Duplicate_Centrul Medical Tuculanu SRL /ID# 170903	Timisoara
Russian Federation	Alliance Biomedical Ural Group /ID# 200972	Izhevsk	Udmurtskaya Respublika
Russian Federation	Kuzbass Regional Clinical Hospital /ID# 200962	Kemerovo	Kemerovskaya Oblast
Russian Federation	National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 204808	Moscow
Russian Federation	Novosibirski Gastrocenter /ID# 217552	Novosibirsk
Russian Federation	Duplicate_Perm state medical university n.a. E.A. Vagner /ID# 207439	Perm	Permskiy Kray
Russian Federation	Duplicate_St. Petersburg State Pediatric Medical University /ID# 211978	Saint Petersburg	Sankt-Peterburg
Russian Federation	City Clinical Hospital No. 31 /ID# 208872	St. Petersburg
Russian Federation	Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 200970	Stavropol	Stavropol Skiy Kray
Russian Federation	Tver Regional Clinical Hospital /ID# 206858	Tver	Tverskaya Oblast
Russian Federation	Regional Clinical Hospital #1 /ID# 200973	Tyumen	Tyumenskaya Oblast
Russian Federation	Ulyanovsk Regional Clinical Hospital /ID# 200964	Ulyanovsk
Serbia	Clin Hosp Ctr Bezanijska Kosa /ID# 157050	Belgrade	Beograd
Serbia	Clinical Hosp Center Zvezdara /ID# 157052	Belgrade	Beograd
Serbia	Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 212799	Belgrade
Serbia	Military Medical Academy /ID# 157053	Belgrade	Beograd
Serbia	University Children's Hospital 'Tirsova' /ID# 211482	Belgrade
Serbia	University Clinical Center Serbia /ID# 157047	Belgrade	Beograd
Serbia	Duplicate_University Clinical Center Kragujevac /ID# 157049	Kragujevac	Sumadijski Okrug
Serbia	General Hospital Leskovac /ID# 209575	Leskovac
Serbia	University Clinical Center Vojvodina /ID# 157046	Novi Sad
Singapore	KL Ling Gastroenterology and Liver Clinic /ID# 205741	Singapore
Singapore	National University Hospital /ID# 160667	Singapore
Singapore	Singapore General Hospital /ID# 160668	Singapore
Slovakia	Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 156468	Banska Bystrica
Slovakia	KM Management, spol. s.r.o. /ID# 206764	Nitra	Nitriansky Kraj
Slovakia	Gastro I., s.r.o. /ID# 156469	Prešov	Presovsky Kraj
South Africa	Private Practice Dr MN Rajabally /ID# 163112	Cape Town	Western Cape
South Africa	Spoke Research Inc /ID# 158116	CAPE TOWN Milnerton	Western Cape
South Africa	Clinresco Centers /ID# 163865	Johannesburg	Gauteng
South Africa	Wits Clinical Research /ID# 158114	Johannesburg	Gauteng
Spain	Hospital Clinic de Barcelona /ID# 157552	Barcelona
Spain	Hospital Universitario Basurto /ID# 205190	Bilbao	Vizcaya
Spain	Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 157553	Ferrol	A Coruna
Spain	Hospital Universitari de Bellvitge /ID# 208207	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital General Universitario Gregorio Maranon /ID# 161145	Madrid
Spain	Hospital Universitario La Paz /ID# 159235	Madrid
Spain	Hospital Universitario Puerta de Hierro - Majadahonda /ID# 157573	Majadahonda	Madrid
Spain	Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159237	Sabadell	Barcelona
Spain	Hospital Universitario de Salamanca /ID# 157558	Salamanca
Spain	Hospital Universitario Virgen Macarena /ID# 159967	Sevilla
Spain	Hospital Clinico Universitario de Valencia /ID# 209700	Valencia
Spain	Hospital Universitario y Politecnico La Fe /ID# 157556	Valencia
Spain	Hospital Clinico Universitario Lozano Blesa /ID# 212525	Zaragoza
Spain	Hospital Universitario Miguel Servet /ID# 157557	Zaragoza
Sweden	Duplicate_Sahlgrenska University Hospital /ID# 163792	Gothenburg	Vastra Gotalands Lan
Sweden	Duplicate_Sahlgrenska University Hospital /ID# 163797	Gothenburg	Vastra Gotalands Lan
Sweden	Skane University hospital /ID# 211745	Malmo	Skane Lan
Sweden	Karolinska University Hospital Solna /ID# 212025	Solna	Stockholms Lan
Sweden	Danderyd Hospital /ID# 202138	Stockholm	Stockholms Lan
Sweden	GHP Stockholm Gastro Center /ID# 211748	Stockholm	Stockholms Lan
Sweden	Medicinkliniken, Gastroenheten /ID# 163744	Stockholm
Switzerland	Universitätsspital Basel /ID# 164554	Basel Town	Basel-Stadt
Switzerland	Inselspital, Universitaetsspital Bern /ID# 163535	Bern
Switzerland	University Hospital Zurich /ID# 163536	Zurich	Zuerich
Taiwan	China Medical University Hospital /ID# 160141	Taichung
Taiwan	Taichung Veterans General Hospital /ID# 160140	Taichung
Taiwan	National Cheng Kung University Hospital /ID# 160142	Tainan
Taiwan	Taipei Veterans General Hosp /ID# 212712	Taipei
Taiwan	National Taiwan University Hospital /ID# 162190	Taipei City	Taipei
Ukraine	Kharkiv City Clinical Hospital No.2 n.a. Prof. O.O. Shalimov /ID# 165657	Kharkiv
Ukraine	Municipal Nonprofit Enterprise Kherson city clinical hospital n.a. Y.Y. Karabel /ID# 212399	Kherson
Ukraine	Communal Noncommercial Institution Consultative and Diagnostic Center of Desnian /ID# 165659	Kyiv
Ukraine	Kyiv City Clinical Hospital No.18 /ID# 162531	Kyiv
Ukraine	Kyiv Railway Clinical Hosp No.2 /ID# 217366	Kyiv
Ukraine	Medical Center of LLC Medbud-Clinic /ID# 216998	Kyiv
Ukraine	Medical Center OK Clinic LLC, International Institute of Clinical Research /ID# 211998	Kyiv
Ukraine	ME Volyn Regional Clinical Hospital of Volyn Regional Council /ID# 206789	Lutsk
Ukraine	Lviv Railway Clinical Hospital of branch Healthcare Centers of Public Joint Stoc /ID# 165658	Lviv
Ukraine	Transcarpathian Regional Clinical Hospital n.a. Andriy Novak /ID# 167960	Uzhgorod
Ukraine	?linic Scientific Research Inst of Invalid Rehab ESM? M I Pyrogov VNMU /ID# 212000	Vinnytsia	Vinnytska Oblast
Ukraine	CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 216474	Vinnytsia	Vinnytska Oblast
United Kingdom	Barnsley Hospital NHS Foundation Trust /ID# 202773	Barnsley
United Kingdom	University Hospitals Birmingham NHS Foundation Trust /ID# 157545	Birmingham
United Kingdom	Addenbrooke's Hospital /ID# 158034	Cambridge	Cambridgeshire
United Kingdom	Ashford and St Peter's Hospitals NHS Foundation Trust /ID# 207936	Chertsey	Surrey
United Kingdom	NHS Lothian /ID# 207448	Edinburgh
United Kingdom	Duplicate_Royal Devon University Healthcare NHS Foundation Trust /ID# 157544	Exeter	Devon
United Kingdom	NHS Greater Glasgow and Clyde /ID# 202568	Glasgow	Scotland
United Kingdom	Calderdale and Huddersfield NHS Foundation Trust /ID# 209570	Huddersfield
United Kingdom	Hull University Teaching Hospitals NHS Trust /ID# 158761	Hull	East Riding Of Yorkshire
United Kingdom	Leeds Teaching Hospitals NHS Trust /ID# 157550	Leeds
United Kingdom	Barts Health NHS Trust /ID# 163713	London	London, City Of
United Kingdom	Guys and St Thomas NHS Foundation Trust /ID# 157546	London	London, City Of
United Kingdom	King's College Hospital NHS Foundation Trust /ID# 158760	London
United Kingdom	The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 163708	Newcastle upon Tyne
United Kingdom	Oxford University Hospitals NHS Foundation Trust /ID# 158036	Oxford	Oxfordshire
United Kingdom	Northern Care Alliance NHS Group /ID# 207766	Salford
United States	University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 157126	Ann Arbor	Michigan
United States	TX Clinical Research Institute /ID# 159404	Arlington	Texas
United States	Atlanta Gastro Assoc /ID# 154724	Atlanta	Georgia
United States	GI Alliance /ID# 161963	Baton Rouge	Louisiana
United States	Inquest Clinical Research /ID# 165694	Baytown	Texas
United States	Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 162262	Brandon	Florida
United States	NY Scientific /ID# 158294	Brooklyn	New York
United States	Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 213447	Burnt Hills	New York
United States	GI Alliance /ID# 209797	Cedar Park	Texas
United States	Texas Digestive Disease Consultants /ID# 209946	Cedar Park	Texas
United States	Univ NC Chapel Hill /ID# 154833	Chapel Hill	North Carolina
United States	Medical University of South Carolina /ID# 212858	Charleston	South Carolina
United States	Atrium Health Carolinas Medical Center /ID# 158428	Charlotte	North Carolina
United States	Clin Res Inst of Michigan, LLC /ID# 169179	Chesterfield	Michigan
United States	Metropolitan Gastroenterology Group - Chevy Chase /ID# 154832	Chevy Chase	Maryland
United States	Duplicate_Northwestern University /ID# 158261	Chicago	Illinois
United States	The University of Chicago Medical Center /ID# 157124	Chicago	Illinois
United States	Tri-State Endoscopy Center /ID# 154927	Cincinnati	Ohio
United States	South Lake Pain Institute, Inc /ID# 162808	Clermont	Florida
United States	Cleveland Clinic Main Campus /ID# 209226	Cleveland	Ohio
United States	Peak Gastroenterology Associates, PC /ID# 165843	Colorado Springs	Colorado
United States	Gastro Center of Maryland /ID# 165001	Columbia	Maryland
United States	Optimed Research, Ltd. /ID# 167887	Columbus	Ohio
United States	The Ohio State University /ID# 164708	Columbus	Ohio
United States	Gastro One /ID# 154726	Cordova	Tennessee
United States	Southern California Res. Ctr. /ID# 211991	Coronado	California
United States	Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 159406	Dallas	Texas
United States	Duplicate_Western Connecticut Medical Group /ID# 165879	Danbury	Connecticut
United States	Hometown Urgent Care and Resea /ID# 170464	Dayton	Ohio
United States	Omega Research Maitland, LLC /ID# 171082	DeBary	Florida
United States	Universal Axon Clinical Research /ID# 165428	Doral	Florida
United States	NorthShore University HealthSystem /ID# 158265	Evanston	Illinois
United States	Plains Clinical Research Center, LLC /ID# 169718	Fargo	North Dakota
United States	Intercity Advanced Gastroentertology Center /ID# 215205	Fresh Meadows	New York
United States	Duplicate_DHAT Research Institute /ID# 158208	Garland	Texas
United States	Duplicate_Northwell Health Division of Gastroenterology at Great Neck /ID# 168738	Great Neck	New York
United States	Gastroenterology Associates, P.A. of Greenville /ID# 154904	Greenville	South Carolina
United States	Houma Digestive Health Special /ID# 158264	Houma	Louisiana
United States	Baylor College of Medicine /ID# 158203	Houston	Texas
United States	Centex Studies, Inc. - Houston /ID# 201219	Houston	Texas
United States	Vilo Research Group Inc /ID# 207655	Houston	Texas
United States	Duplicate_Newport Huntington Medical Group /ID# 213035	Huntington Beach	California
United States	Nature Coast Clinical Research - Inverness /ID# 159408	Inverness	Florida
United States	East Tennessee Research Institute /ID# 168739	Johnson City	Tennessee
United States	SIH Research Mumtaz, Inc /ID# 163083	Kissimmee	Florida
United States	UC San Diego Health Systems /ID# 155555	La Jolla	California
United States	NYU Langone Long Island Clinical Research Associates /ID# 154829	Lake Success	New York
United States	Las Vegas Medical Research /ID# 160170	Las Vegas	Nevada
United States	Revival Research Institute, Inc /ID# 210985	Las Vegas	Nevada
United States	Duplicate_University of Kentucky Chandler Medical Center /ID# 157120	Lexington	Kentucky
United States	Alliance Medical Research /ID# 163837	Lighthouse Point	Florida
United States	Atria Clinical Research /ID# 164505	Little Rock	Arkansas
United States	Rocky Mountain Pediatric Gastroenterology /ID# 207170	Lone Tree	Colorado
United States	United Medical Doctors /ID# 207888	Los Alamitos	California
United States	Gastrointestinal Biosciences Clinical Trials, LLC /ID# 162657	Los Angeles	California
United States	TLC Clinical Research Inc /ID# 212719	Los Angeles	California
United States	University of Louisville Hospital /ID# 210525	Louisville	Kentucky
United States	Gastroenterology Associates of Central Georgia, LLC /ID# 154850	Macon	Georgia
United States	Cfagi Llc /Id# 202479	Maitland	Florida
United States	Clinical Neuroscience Solutions - Memphis /ID# 164180	Memphis	Tennessee
United States	Great Lakes Gastroenterology Research, LLC /ID# 201770	Mentor	Ohio
United States	Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211884	Mesa	Arizona
United States	Coral Research Clinic /ID# 158456	Miami	Florida
United States	South Florida Research Ph I-IV, Inc. /ID# 161832	Miami	Florida
United States	Sylvester Comprehensive Cancer Center /ID# 155007	Miami	Florida
United States	West Virginia University Hospitals /ID# 167941	Morgantown	West Virginia
United States	United Medical Doctors - Murrieta /ID# 158300	Murrieta	California
United States	Gastroenterology Group Naples /ID# 165204	Naples	Florida
United States	Vanderbilt University Medical Center /ID# 157121	Nashville	Tennessee
United States	Digestive Disease Care /ID# 211777	New Hyde Park	New York
United States	Delricht Research /ID# 206644	New Orleans	Louisiana
United States	Nola Research Works, LLC /ID# 161317	New Orleans	Louisiana
United States	Advanced Research Institute, Inc /ID# 161966	New Port Richey	Florida
United States	Columbia Univ Medical Center /ID# 161899	New York	New York
United States	Icahn School of Medicine at Mount Sinai /ID# 165612	New York	New York
United States	Lenox Hill Hospital /ID# 168467	New York	New York
United States	NYU Langone Medical Center /ID# 160169	New York	New York
United States	Weill Cornell Medicine /ID# 165878	New York	New York
United States	DiGiovanna Institute for Medical Education & Research /ID# 171126	North Massapequa	New York
United States	Southwest Gastroenterology /ID# 164781	Oak Lawn	Illinois
United States	Advanced Research Institute /ID# 154907	Ogden	Utah
United States	Digestive Disease Specialists /ID# 170775	Oklahoma City	Oklahoma
United States	Hightower Clinical /ID# 211993	Oklahoma City	Oklahoma
United States	University of Nebraska Medical Center /ID# 210058	Omaha	Nebraska
United States	Endoscopic Research, Inc. /ID# 205906	Orlando	Florida
United States	IMIC Inc. Medical Research /ID# 154942	Palmetto Bay	Florida
United States	Phoenix VA Health Care System /ID# 162264	Phoenix	Arizona
United States	Children's Hospital of Pittsburgh of UPMC /ID# 212544	Pittsburgh	Pennsylvania
United States	Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 154873	Raleigh	North Carolina
United States	Rapid City Medical Center - GI Research /ID# 163838	Rapid City	South Dakota
United States	Richmond VA Medical Center /ID# 159988	Richmond	Virginia
United States	Mayo Clinic - Rochester /ID# 163086	Rochester	Minnesota
United States	St. Louis University /ID# 161883	Saint Louis	Missouri
United States	Clinical Associates in Research Therapeutics of America, LLC /ID# 161323	San Antonio	Texas
United States	Southern Star Research Institute, LLC /ID# 168773	San Antonio	Texas
United States	University of California San Francisco - Mission Bay /ID# 157127	San Francisco	California
United States	Duplicate_Virginia Mason Medical Center /ID# 155556	Seattle	Washington
United States	Louisiana Research Center, LLC /ID# 162237	Shreveport	Louisiana
United States	Clinical Research of West Florida, Inc /ID# 205865	Tampa	Florida
United States	Clinical Research of West Florida, Inc /ID# 208125	Tampa	Florida
United States	Baylor Scott & White Center for Diagnostic Medicine /ID# 204131	Temple	Texas
United States	Cotton O'Neil Clinical Research Center, Digestive Health /ID# 154722	Topeka	Kansas
United States	Center for Digestive Health /ID# 154683	Troy	Michigan
United States	University of Arizona /ID# 158502	Tucson	Arizona
United States	Adult Gastroenterology Associates - Gen 1 Research /ID# 208864	Tulsa	Oklahoma
United States	Tyler Research Institute, LLC /ID# 166797	Tyler	Texas
United States	Gastro Health & Nutrition - Victoria /ID# 164290	Victoria	Texas
United States	Duplicate_Cedars-Sinai Medical Center-West Hollywood /ID# 163839	West Hollywood	California
United States	Velocity Clinical Research - Salt Lake City /ID# 161778	West Jordan	Utah
United States	Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 161313	Wyoming	Michigan
United States	Digestive Disease Associates, LTD /ID# 208297	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belarus,  Belgium,  Bosnia and Herzegovina,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Croatia,  Czechia,  Denmark,  Egypt,  Estonia,  France,  Germany,  Greece,  Hong Kong,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Singapore,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sub-Study 2: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission	The CDAI is used to evaluate disease activity in patients with Crohn's disease. The CDAI clinical remission is defined as a CDAI score of < 150.	Week 52
Other	Sub-Study 2: Percentage of Participants With Endoscopic Response	Endoscopic response defined as decrease from Baseline of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).	Week 52
Other	Sub-Study 2: Percentage of Participants With Exposure Adjusted Occurrence of CD-related Hospitalizations From Week 0 Through Week 52	Participants with an event that results in admission to the hospital.	Up to Week 52
Primary	Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission	The CDAI is used to evaluate disease activity in patients with Crohn's disease. The CDAI clinical remission is defined as a CDAI score of < 150.	Week 52
Primary	Sub-Study 1: Percentage of Participants With Endoscopic Response	Endoscopic response defined as decrease from Baseline of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).	Week 52
Primary	Sub-Study 3: Number of Participants With Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent AEs are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.	Up to Week 220
Primary	Sub-Study 4: Percentage of Participants With an Observer Rating of Successful Participant Self Administration	Participant who successfully completed the sequence of critical steps in the instructions for use (IFU) without errors to administer study drug via the OBI at Week 0 and 16.	Up to Week 16
Primary	Sub-Study 4: Percentage of Participants who had no Potential Hazards	Measured by an observer on the possible use-related hazards checklist for self-administration with OBI at Week 0 and Week 16.	Up to Week 16
Primary	Sub-Study 4: Percentage of Participants Rating of Acceptability Using Self-Injection Assessment Questionnaire (SIAQ) at Weeks 0, 8, 16	SIAQ evaluations consist of the PRE module, which is self-completed immediately before the first OBI self-injection at baseline, and the POST module, which is self-completed 20 to 40 min following injections at Weeks 0, 8, 16. These modules are completed by participants while alone in a quiet environment.; Participants rate each item of the SIAQ. The ratings are later transformed to scores ranging from 0 (worst experience) to 10 (best experience). The domain score is the mean of the item scores included in the domain. Domain scores are calculated only if at least half of the domain items are completed. Item and domain scores from the PRE module are compared with the corresponding item and domain scores from the POST modules.	Up to Week 16
Primary	Sub-Study 4: Percentage of Participants in CDAI Clinical Remission at Week 0, 16	Clinical remission per average daily stool frequency (SF) and average daily abdominal pain (AP) score.	Up to Week 16
Secondary	Sub-Study 1: Percentage of Participants With Clinical Remission	Clinical remission per average daily stool frequency (SF) and average daily AP score.	Week 52
Secondary	Sub-Study 1: Percentage of Participants With CDAI Clinical Remission Among Participants With CDAI Clinical Remission in Week 0	The CDAI is used to evaluate disease activity in patients with Crohn's disease	Week 52
Secondary	Sub-Study 1: Percentage of Participants With Ulcer-Free Endoscopy	Endoscopic healing was assessed using SES-CD.	Week 52
Secondary	Sub-Study 1: Percentage of Participants With Endoscopic Remission	Endoscopic Remission is defined as SES-CD <= 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable, as scored by a central reviewer	Week 52
Secondary	Sub-Study 1: Change From Baseline of Induction in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)	The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.	Week 52
Secondary	Sub-Study 1: Percentage of Participants Who Discontinued Corticosteroid Use for 90 Days and Achieved Clinical Remission in Participants Taking Steroids at Baseline	Participants who discontinued corticosteroid use and achieved clinical remission per average daily SF and average daily AP score.	Week 52
Secondary	Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response	The CDAI is used to evaluate disease activity in patients with Crohn's disease.	Week 52
Secondary	Sub-Study 1: Percentage of Participants With Stool Frequency (SF) Remission	SF Remission is defined by an average daily SF <= 2.8 and not worse than baseline.	Week 52
Secondary	Sub-Study 1: Percentage of Participants With Abdominal Pain (AP) Remission	AP Remission is defined by an average daily AP <= 1 and not worse than baseline.	Week 52
Secondary	Sub-Study 1: Percentage of Participants With CDAI Clinical Remission and Endoscopic Response	The CDAI is used to evaluate disease activity in patients with Crohn's disease. The CDAI clinical remission is defined as a CDAI score of < 150. Endoscopic response defined as decrease from baseline of > 50% of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).	Week 52
Secondary	Sub-Study 1: Percentage of Participants With Deep Remission	Deep remission defined as participants with both clinical remission (per average daily SF and average daily AP score) and endoscopic remission (assessed using SES-CD).	Week 52
Secondary	Sub-Study 1: Percentage of Participants With Exposure Adjusted Occurrence of CD-related Hospitalizations From Week 0 Through Week 52	Participants with an event that results in admission to the hospital.	Up to Week 52

External Links

•   This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.