A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

Crohn's Disease Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03345836
• Other study ID #: M14-431
• Secondary ID: 2017-001226-18
• Status: Completed
• Phase: Phase 3
• Start date: November 29, 2017
• Est. completion date: August 11, 2021

Study information

• Verified date: July 2022
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 624
• Est. completion date: August 11, 2021
• Est. primary completion date: August 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of CD for at least 3 months prior to Baseline.

• Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score.

• Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader.

• Demonstrated an inadequate response or intolerance to any biologic therapy for infliximab, adalimumab, certolizumab pegol, vedolizumab, and ustekinumab.

• If female, participant must meet the contraception recommendations.

Exclusion Criteria:

• Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.

• Participant not on stable doses of CD related antibiotics, oral aminosalicylates, corticosteroids or methotrexate (MTX).

• Participant with the following ongoing known complications of CD: abscess (abdominal or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.

• Participant with ostomy or ileoanal pouch.

• Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short gut or short bowel syndrome.

• Screening laboratory and other protocol pre-specified analyses show abnormal results.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Matching Placebo for Upadacitinib
Matching placebo tablets
• Upadacitinib
Upadacitinib tablets

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires /ID# 215543	Ciudad Autonoma Buenos Aires	Ciuadad Autonoma De Buenos Aires
Argentina	Cemic /Id# 169184	Ciudad Autonoma de Buenos Aire	Ciuadad Autonoma De Buenos Aires
Argentina	Gedyt /ID# 210019	Ciudad Autonoma de Buenos Aire	Ciuadad Autonoma De Buenos Aires
Argentina	Hospital Privado Univesitario /ID# 169228	Cordoba
Argentina	Hospital Provincial del Centenario /ID# 171254	Rosario	Santa Fe
Argentina	Cardio Alem /ID# 211284	San Isidro	Buenos Aires
Australia	Royal Adelaide Hospital /ID# 171511	Adelaide	South Australia
Australia	Box Hill Hospital /ID# 203734	Box Hill	Victoria
Australia	Concord Repatriation General Hospital /ID# 171509	Concord	New South Wales
Australia	Fiona Stanley Hospital /ID# 171510	Murdoch	Western Australia
Australia	Coral Sea Clinical Research institute /ID# 212987	North Mackay	Queensland
Australia	Mater Misericordiae Limited /ID# 204908	South Brisbane	Queensland
Austria	Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 214467	Salzburg
Austria	Klinik Landstrasse /ID# 203437	Vienna	Wien
Austria	Medizinische Universitaet Wien /ID# 169462	Vienna	Wien
Belgium	AZ Sint-Lucas /ID# 200301	Gent
Belgium	CHU UCL Namur - site Godinne /ID# 200300	Godinne	Namur
Belgium	Universitair Ziekenhuis Leuven /ID# 200298	Leuven	Vlaams-Brabant
Belgium	CHU de Liege Sart Tilman /ID# 200299	Liège	Liege
Belgium	UCL Saint-Luc /ID# 200297	Woluwe-Saint-Lambert	Bruxelles-Capitale
Bosnia and Herzegovina	University Clinical Centre of the Republic of Srpska /ID# 208050	Banja Luka	Republika Srpska
Bosnia and Herzegovina	Clinical Center University of Sarajevo /ID# 203885	Sarajevo
Bosnia and Herzegovina	Polyclinic and Daily Hospital Dr. Al-Tawil /ID# 217841	Sarajevo
Bosnia and Herzegovina	University Clinical Center Tuzla /ID# 210324	Tuzla	Tuzlanski
Brazil	Upeclin Fmb - Unesp /Id# 166876	Botucatu	Sao Paulo
Brazil	Hospital Nossa Senhora das Graças /ID# 166869	Curitiba	Parana
Brazil	Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 166870	Goiânia	Goias
Brazil	Hospital de Clinicas de Porto Alegre /ID# 166872	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 166874	Ribeirão Preto	Sao Paulo
Brazil	Faculdade de Medicina do ABC /ID# 208327	Santo André	Sao Paulo
Brazil	Kaiser Clinica e Hospital Dia /ID# 166873	Sao Jose Do Rio Preto	Sao Paulo
Bulgaria	UMHAT Kaspela EOOD /ID# 167617	Plovdiv
Bulgaria	Duplicate_Second MHAT Sofia /ID# 167618	Sofia
Bulgaria	MHAT Trakia /ID# 201678	Stara Zagora
Canada	University of Calgary - Cumming School of Medicine - Adult Cystic Fibrosis Clini /ID# 166963	Calgary	Alberta
Canada	Allen Whey Khye Lim Professional Corporation /ID# 168041	Edmonton	Alberta
Canada	Covenant Health /ID# 166966	Edmonton	Alberta
Canada	QEII - Health Sciences Centre /ID# 169306	Halifax	Nova Scotia
Canada	CHAU- Hotel-Dieu de Levis /ID# 166958	Levis	Quebec
Canada	Crchum /Id# 170121	Montreal	Quebec
Canada	Montreal General Hospital - McGill University Health Center /ID# 170010	Montreal	Quebec
Canada	Fraser Clinical Trials Inc /ID# 166957	New Westminster	British Columbia
Canada	Scott Shulman Medicine Professional Corporation /ID# 169064	North Bay	Ontario
Canada	Taunton Surgical Centre /ID# 168039	Oshawa	Ontario
Canada	The Ottawa Hospital /ID# 212413	Ottawa	Ontario
Canada	CIUSSS de l'Estrie - CHUS /ID# 170935	Sherbrooke	Quebec
Canada	Medicor Research Inc /ID# 166967	Sudbury	Ontario
Canada	GIRI Gastrointestinal Research Institute /ID# 166964	Vancouver	British Columbia
Canada	Toronto Digestive Disease Asso /ID# 166961	Vaughan	Ontario
Chile	Hospital Guillermo Grant Benavente de Concepción /ID# 212422	Concepción
Chile	CTR Estudios Clinicos /ID# 200650	Providencia
Chile	Hospital Clinico Universidad De Los Andes /ID# 207465	Santiago
Chile	M y F Estudios Clínicos /ID# 169995	Santiago	Region Metropolitana Santiago
Chile	Research Group /ID# 203180	Santiago	Region Metropolitana De Santiago
China	Beijing Friendship Hospital /ID# 204536	Beijing
China	The First Hospital of Jilin University /ID# 206867	Changchun	Jilin
China	The Second Hospital Central South University /ID# 204075	Changsha
China	Zhongshan Hospital Xiamen University /ID# 204985	Fujian	Anhui
China	Nanfang Hospital of Southern Medical University /ID# 204074	Guangzhou
China	Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 205226	Guangzhou	Guangdong
China	The Sixth Affiliated Hosp Sun /ID# 204049	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 204068	Hangzhou	Zhejiang
China	The second Affiliated hospital of Zhejiang University school of Medicine /ID# 204078	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Nanchang University /ID# 204070	Nanchang	Jiangxi
China	Nanjing Drum Tower Hospital /ID# 204869	Nanjing	Jiangsu
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 204072	Shanghai	Shanghai
China	Duplicate_Tianjin Med Univ General Hosp /ID# 206993	Tianjin
China	Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 204069	Wuhan
China	Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 204096	Wuhan	Hubei
Colombia	Hospital San Vicente de Paul /ID# 200028	Medellin	Antioquia
Colombia	Hospital Pablo Tobon Uribe /ID# 202405	Medellín	Antioquia
Croatia	UHC Split /ID# 171206	Split
Croatia	Zadar General Hospital /ID# 205534	Zadar
Croatia	Clinical Hospital Dubrava /ID# 171186	Zagreb	Grad Zagreb
Croatia	Klinicki bolnicki centar Sestre milosrdnice /ID# 171190	Zagreb	Grad Zagreb
Croatia	Klinicki bolnicki centar Zagreb /ID# 171201	Zagreb	Grad Zagreb
Croatia	Poliklinika Solmed /ID# 211518	Zagreb	Grad Zagreb
Czechia	Hepato-Gastroenterologie HK, s.r.o. /ID# 171566	Hradec Kralove
Czechia	ResTrial s.r.o. /ID# 208652	Praha
Czechia	ARTROSCAN s.r.o. /ID# 171592	Trebovice
Denmark	Nordsjaellands Hospital /ID# 200613	Frederikssund	Hovedstaden
Denmark	Herlev Hospital /ID# 200782	Herlev	Hovedstaden
Denmark	Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 200611	Hvidovre	Hovedstaden
Denmark	Duplicate_Sjaellands Universitets Hospital /ID# 200783	Roskilde	Sjælland
Egypt	Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171010	Alexandria
Egypt	Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171015	Alexandria
Egypt	Air Force Specialized Hospital /ID# 170995	Cairo
Egypt	Clinical Research Center, Faculty of Medicine, Cairo university /ID# 209557	Cairo
Egypt	Faculty of Medicine Ain Shams Research Institute- Clinical Research Centre /ID# 209565	Cairo
Egypt	National Hepatology and Tropical Medicine Research Institute /ID# 170990	Cairo
Estonia	Tartu University Hospital /ID# 203140	Tartu Linn	Tartumaa
France	CHU Amiens-Picardie Site Sud /ID# 171016	Amiens CEDEX 1	Somme
France	CHRU Tours - Hopital Trousseau /ID# 169786	Chambray Les Tours
France	Hopital Beaujon /ID# 171011	Clichy	Ile-de-France
France	Duplicate_CHU Henri Mondor /ID# 169787	Creteil
France	CHRU Lille - Hopital Claude Huriez /ID# 206539	Lille	Hauts-de-France
France	Duplicate_Hopital Saint Eloi /ID# 170646	Montpellier CEDEX 5	Herault
France	Chu de Nice-Hopital L'Archet Ii /Id# 171009	Nice	Alpes-Maritimes
France	Polyclinique Grand Sud /ID# 170649	Nimes Cedex
France	CHU Bordeaux - Hopital Haut Lévêque /ID# 207414	Pessac CEDEX	Gironde
France	HCL - Hôpital Lyon Sud /ID# 171014	Pierre Benite CEDEX	Auvergne-Rhone-Alpes
France	CHU de SAINT ETIENNE - Hopital Nord /ID# 171018	St. Priest En Jarez	Loire
France	CHU Toulouse - Hopital Rangueil /ID# 169785	Toulouse
France	CHRU Nancy - Hôpitaux de Brabois /ID# 170985	Vandœuvre-lès-Nancy	Meurthe-et-Moselle
Germany	Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 169067	Berlin
Germany	Gastroenterologie am Mexikoplatz /ID# 203573	Berlin
Germany	Universitaetsklinikum Erlangen /ID# 203551	Erlangen	Bayern
Germany	Universitaetsmedizin Essen St. Josef Krankenhaus Werden /ID# 203571	Essen
Germany	Agaplesion Markus Krankenhaus /ID# 168777	Frankfurt am Main
Germany	Universitaetsklinikum Frankfurt /ID# 203565	Frankfurt am Main	Hessen
Germany	Universitaetsklinikum Halle (Saale) /ID# 207454	Halle (Saale)
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 168779	Kiel	Schleswig-Holstein
Germany	Universitatsklinikum Mannheim /ID# 168778	Mannheim	Baden-Wuerttemberg
Germany	Medizinisches Versorgungszentrum Portal 10 /ID# 200213	Muenster
Germany	Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 206740	Saarbrücken	Saarland
Germany	Universitaetsklinikum Ulm /ID# 203563	Ulm	Baden-Wuerttemberg
Greece	General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 167037	Athens
Greece	General Hospital of Athens Ippokratio /ID# 167036	Athens	Attiki
Greece	General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202103	Athens	Attiki
Greece	University General Hospital of Heraklion PA.G.N.I /ID# 167035	Heraklion	Kriti
Greece	Tzaneio general hospital of Piraeus /ID# 206432	Piraeus	Attiki
Greece	Genl Hosp Thess Ippokrateio /ID# 208824	Thessaloniki
Hong Kong	Queen Mary Hospital /ID# 171217	Hong Kong
Hungary	Magyar Honvedseg Egeszsegugyi Kozpont /ID# 201719	Budapest
Hungary	Obudai Egeszsegugyi Centrum Kft. /ID# 201891	Budapest	Pest
Hungary	Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 201720	Debrecen
Hungary	Bugat Pal Korhaz /ID# 201889	Gyöngyös	Heves
Hungary	CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 205546	Miskolc	Borsod-Abauj-Zemplen
Hungary	Mentahaz Maganorvosi Kozpont /ID# 201890	Szekesfehervar
Ireland	Mercy University Hospital /ID# 206510	Cork
Israel	Barzilai Medical Center /ID# 223372	Ashkelon
Israel	Soroka University Medical Center /ID# 169912	Be'er Sheva	HaDarom
Israel	Assaf Harofeh Medical Center /ID# 204870	Be'Er Ya'Akov
Israel	Hadassah Medical Center-Hebrew University /ID# 169927	Jerusalem
Israel	Rabin Medical Center /ID# 202635	Petakh Tikva
Israel	Kaplan Medical Center /ID# 170277	Rehovot
Israel	Tel Aviv Sourasky Medical Center /ID# 204876	Tel Aviv-Yafo	Tel-Aviv
Italy	A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 168173	Bologna
Italy	A.O. Per L'Emergenza Cannizzaro /ID# 168176	Catania
Italy	University of Catanzaro /ID# 201920	Catanzaro	Calabria
Italy	Policlinico San Martino/Univer /ID# 168177	Genova
Italy	ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 168167	Milano
Italy	Azienda Ospedaliero-Universitaria di Modena /ID# 200008	Modena
Italy	IRCCS Ospedale Sacro Cuore Don Calabria /ID# 168172	Negrar	Verona
Italy	A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 168175	Palermo
Italy	Azienda Ospedaliero Universitaria Pisana-Stabilimento di Cisanello /ID# 202420	Pisa
Italy	Azienda Ospedaliera San Camillo Forlanini /ID# 168170	Rome	Lazio
Italy	Fondazione PTV Policlinico Tor Vergata /ID# 168174	Rome	Roma
Italy	Policlinico Universitario Campus Bio-Medico /ID# 168169	Rome	Lazio
Italy	Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 168168	Rome	Roma
Italy	Istituto Clinico Humanitas /ID# 168171	Rozzano	Milano
Japan	Asahikawa Medical University Hospital /ID# 167133	Asahikawa-shi	Hokkaido
Japan	Tokyo Medical And Dental University, Medical Hospital /ID# 165948	Bunkyo-ku	Tokyo
Japan	NHO Fukuyama Medical Center /ID# 167139	Fukuyama-shi	Hiroshima
Japan	Duplicate_Tokai University Hachioji Hospital /ID# 165951	Hachioji-shi	Tokyo
Japan	Hirosaki National Hospital /ID# 165944	Hirosaki-shi	Aomori
Japan	Hiroshima University Hospital /ID# 166006	Hiroshima-shi	Hiroshima
Japan	Idzuro Imamura Hospital /ID# 206651	Kagoshima-shi	Kagoshima
Japan	Imamura General Hospital /ID# 227136	Kagoshima-shi	Kagoshima
Japan	Sameshima Hospital /ID# 206674	Kagoshima-shi	Kagoshima
Japan	Kanazawa University Hospital /ID# 169215	Kanazawa-shi	Ishikawa
Japan	Nara Medical University Hospital /ID# 169216	Kashihara-shi	Nara
Japan	Aoyama Clinic /ID# 166001	Kobe-shi	Hyogo
Japan	Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 166002	Kurashiki-shi	Okayama
Japan	Kurume University Hospital /ID# 166004	Kurume-shi	Fukuoka
Japan	Japanese Red Cross Kyoto Daiichi Hosital /ID# 165958	Kyoto-shi	Kyoto
Japan	Kyoto University Hospital /ID# 169888	Kyoto-shi	Kyoto
Japan	The Jikei University Hospital /ID# 167142	Minato-ku	Tokyo
Japan	Kyorin University Hospital /ID# 165950	Mitaka-shi	Tokyo
Japan	Iwate Medical University Uchimaru Medical Center /ID# 202407	Morioka-shi	Iwate
Japan	Aichi Medical University Hospital /ID# 165957	Nagakute-shi	Aichi
Japan	Nagoya City University Hospital /ID# 165956	Nagoya shi	Aichi
Japan	Nagoya University Hospital /ID# 165955	Nagoyashi	Aichi
Japan	Niigata University Medical & Dental Hospital /ID# 170044	Niigata-shi	Niigata
Japan	Hyogo College of Medicine College Hospital /Id# 200173	Nishinomiya-shi	Hyogo
Japan	Ishida Clinic of IBD and Gastroenterology /ID# 167134	Oita-shi	Oita
Japan	Okayama University Hospital /ID# 167355	Okayama-shi	Okayama
Japan	Kinshukai Infusion Clinic /ID# 218871	Osaka-shi	Osaka
Japan	Osaka City University Hospital /ID# 166007	Osaka-shi	Osaka
Japan	Shiga University of Medical Science Hospital /ID# 167141	Otsu-shi	Shiga
Japan	Tokitokai Tokito clinic /ID# 165945	Saitama-shi	Saitama
Japan	Toho University Sakura Medical Center /ID# 165949	Sakura-shi	Chiba
Japan	Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 165943	Sapporo-shi	Hokkaido
Japan	Sapporo Medical University Hospital /ID# 167137	Sapporo-shi	Hokkaido
Japan	Tohoku University Hospital /ID# 167135	Sendai-shi	Miyagi
Japan	Tokyo Women's Medical University Hospital /ID# 205981	Shinjuku-ku	Tokyo
Japan	Osaka University Hospital /ID# 169662	Suita-shi	Osaka
Japan	NHO Shizuoka Medical Center /ID# 167138	Sunto-gun	Shizuoka
Japan	National Hospital Organization Takasaki General Medical Center /ID# 167136	Takasaki-shi	Gunma
Japan	Osaka Medical and Pharmaceutical University Hospital /ID# 206324	Takatsuki-shi	Osaka
Japan	Toyama Prefectural Central Hospital /ID# 217833	Toyama-shi	Toyama
Japan	Toyohashi Municipal Hospital /ID# 200174	Toyohashi-shi	Aichi
Japan	Japanese Red Cross Wakayama Medical Center /ID# 200638	Wakayama-shi	Wakayama
Japan	Wakayama Medical University Hospital /ID# 169481	Wakayama-shi	Wakayama
Japan	Yamagata University Hospital /ID# 200156	Yamagata-shi	Yamagata
Japan	Kenseikai Dongo Hospital /ID# 208103	Yamatotakada-shi	Nara
Japan	Yokkaichi Hazu Medical Center /ID# 167191	Yokkaichi-shi	Mie
Korea, Republic of	Dong-A University Hospital /ID# 167582	Busan
Korea, Republic of	Inje University Haeundae Hospital /ID# 202629	Busan
Korea, Republic of	Pusan National University Hospital /ID# 167580	Busan
Korea, Republic of	Kyungpook National Univ Hosp /ID# 207015	Daegu
Korea, Republic of	Hayang University GuriHospital /ID# 167578	Guri	Gyeonggido
Korea, Republic of	CHA University Bundang Medical Center /ID# 167583	Seongnam si	Gyeonggido
Korea, Republic of	Chung-Ang University Hostipal /ID# 207017	Seoul
Korea, Republic of	Kangbuk Samsung Hospital /ID# 167577	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Samsung Medical Center /ID# 167579	Seoul
Korea, Republic of	Yonsei University Health System Severance Hospital /ID# 167581	Seoul	Seoul Teugbyeolsi
Latvia	Digestive Disease Center Gastro /ID# 169517	Riga
Latvia	Pauls Stradins Clinical University Hospital /ID# 169493	Riga
Latvia	Riga East Clinical University Hospital /ID# 169496	Riga
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 207263	Kaunas
Lithuania	Vilnius University Hospital Santaros Klinikos /ID# 203285	Vilnius
Malaysia	Hospital Sultanah Bahiyah /ID# 202627	Alor Setar	Kedah
Malaysia	Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 170778	Kuala Lumpur	Selangor
Mexico	Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 206779	Guadalajara	Jalisco
Mexico	Morales Vargas Centro de Investigacion S.C. /ID# 203495	Leon	Guanajuato
Mexico	Instituto de Investigaciones Aplicadas a la Neurociencias A.C. /ID# 207143	Victoria de Durango	Durango
Netherlands	Academisch Medisch Centrum /ID# 166924	Amsterdam
Netherlands	Medisch Spectrum Twente /ID# 170297	Enschede
Netherlands	Zuyderland Medisch Centrum /ID# 169698	Heerlen	Limburg
Netherlands	Radboud Universitair Medisch Centrum /ID# 166925	Nijmegen	Gelderland
Poland	Malopolskie Centrum Kliniczne /ID# 202166	Krakow	Malopolskie
Poland	Centrum Medyczne Reuma Park w Warszawie /ID# 200488	Warsaw	Mazowieckie
Poland	WIP Warsaw IBD Point Profesor Kierkus /ID# 224300	Warsaw	Mazowieckie
Poland	Centrum Zdrowia MDM /ID# 200486	Warszawa	Mazowieckie
Poland	Vistamed /ID# 208570	Wroclaw	Dolnoslaskie
Portugal	Hospital Garcia de Orta, EPE /ID# 170234	Almada
Portugal	Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 170225	Guimaraes	Braga
Portugal	Hospital Egas Moniz /ID# 170249	Lisbon	Porto
Portugal	Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 200606	Ponte de Lima	Viana Do Castelo
Portugal	Centro Hospitalar Universitario de Sao Joao, EPE /ID# 170231	Porto
Puerto Rico	Mindful Medical Research /ID# 203357	San Juan
Puerto Rico	School of Medicine University of Puerto Rico-Medical Science Campus /ID# 166770	San Juan
Romania	Clinica GASTRO MED SRL /ID# 206367	Cluj-Napoca	Cluj
Romania	Institutul Clinic Fundeni /ID# 167826	Sector 2	Bucuresti
Romania	Cabinet Particular Policlinic Algomed /ID# 167827	Timi?oara
Russian Federation	Immanuel Kant Baltic Federal University /ID# 202128	Kaliningrad	Kaliningradskaya Oblast
Russian Federation	Kazan State Medical University /ID# 169574	Kazan	Tatarstan, Respublika
Russian Federation	Olla-Med Clinic /ID# 208721	Moscow
Russian Federation	P.A. Bayandin Murmansk Regiona /ID# 169575	Murmansk
Russian Federation	LLC Medical Center /ID# 209233	Novosibirsk	Novosibirskaya Oblast
Russian Federation	Perm Clinical Center of the Federal Medical and Biological Agency /ID# 202988	Perm	Permskiy Kray
Russian Federation	Republican hospital named after V.A. Baranov /ID# 206487	Petrozavodsk
Russian Federation	Euromedservice /ID# 206609	Pushkin
Russian Federation	LLC Novaya Klinika /ID# 206615	Pyatigorsk	Stavropol Skiy Kray
Russian Federation	X7 Clinical Research Center /ID# 216349	Saint Petersburg
Russian Federation	City Clinical Hospital No. 31 /ID# 208870	St. Petersburg
Russian Federation	Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 202995	Stavropol	Stavropol Skiy Kray
Serbia	Clin Hosp Ctr Bezanijska Kosa /ID# 168799	Belgrade	Beograd
Serbia	Clinical Hosp Center Zvezdara /ID# 168221	Belgrade	Beograd
Serbia	Military Medical Academy /ID# 168784	Belgrade	Beograd
Serbia	University Clinical Center Serbia /ID# 168220	Belgrade	Beograd
Serbia	University Clinical Center Kragujevac /ID# 205858	Kragujevac	Sumadijski Okrug
Serbia	Clinical Center Vojvodina /ID# 168222	Novi Sad	Vojvodina
Singapore	Gleneagles Medical Centre /ID# 206530	Singapore
Singapore	KL Ling Gastroenterology and Liver Clinic /ID# 217963	Singapore
Singapore	Tan Tock Seng Hospital /ID# 203159	Singapore
Slovakia	Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 169952	Banska Bystrica
Slovakia	KM Management, spol. s.r.o. /ID# 170199	Nitra
Slovenia	Univ Medical Ctr Ljubljana /ID# 211042	Ljubljana
South Africa	Farmovs (Pty) Ltd /Id# 207536	Bloemfontein	Free State
South Africa	Dr JP Wright /ID# 170885	Cape Town	Western Cape
South Africa	Private Practice Dr MN Rajabally /ID# 169852	Cape Town	Western Cape
South Africa	Lenasia Clinical Trial Centre /ID# 205144	Johannesburg	Gauteng
South Africa	Wits Clinical Research Site /ID# 170851	Johannesburg	Gauteng
Spain	Hospital Universitario A Coruna - CHUAC /ID# 203908	A Coruna
Spain	Hospital Clinic de Barcelona /ID# 171242	Barcelona
Spain	Hospital Universitario Vall d'Hebron /ID# 171237	Barcelona
Spain	Hospital Universitario de Girona Doctor Josep Trueta /ID# 202040	Girona
Spain	Hospital Juan Ramon Jimenez /ID# 171243	Huelva
Spain	Hospital Universitario Dr. Negrin /ID# 171238	Las Palmas de Gran Canaria	Las Palmas
Spain	Hospital Universitario La Paz /ID# 171241	Madrid
Spain	Hospital Universitari Son Espases /ID# 201997	Palma de Mallorca	Illes Balears
Spain	Complejo Hospitalario de Navarra /ID# 202038	Pamplona	Navarra
Spain	Hospital Unversitario Marques de Valdecilla /ID# 202039	Santander	Cantabria
Spain	Hospital Universitario Virgen Macarena /ID# 171240	Sevilla
Spain	Hospital Universitario y Politecnico La Fe /ID# 201988	Valencia
Sweden	Alingsas lasarett /ID# 170838	Alingsas	Vastra Gotalands Lan
Sweden	Sodra Alvsborgs sjukhus /ID# 202889	Boras	Vastra Gotalands Lan
Sweden	Sahlgrenska University Hospital /ID# 169031	Gothenburg	Vastra Gotalands Lan
Sweden	Hallands Hospital Halmstad /ID# 170840	Halmstad	Hallands Lan
Switzerland	Inselspital, Universitätsspital Bern /ID# 171006	Bern
Switzerland	Universitätsspital Zürich /ID# 170999	Zürich	Zuerich
Taiwan	National Taiwan University Hospital /ID# 169789	Taipei City
Taiwan	Linkou Chang Gung Memorial Ho /ID# 169788	Taoyuan City
Turkey	Ankara Univ Medical Faculty /ID# 206412	Ankara
Turkey	Inonu Universitesi Turgut Ozal /ID# 201267	Battalgazi/malatya
Turkey	Mustafa Kemal University Medic /ID# 171318	Hatay
Turkey	Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 200280	Istanbul
Turkey	Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171316	Istanbul
Turkey	Acibadem Kozyatagi Hospital /ID# 209405	Kadikoy	Istanbul
Turkey	Erciyes University Medical Fac /ID# 171321	Melikgazi	Kayseri
Turkey	Mersin University Medical /ID# 171320	Mersin
Turkey	Sisli Etfal Train & Res Hosp /ID# 171317	Sisli
Turkey	Gazi Universitesi Tip Fakultes /ID# 217443	Yenimahalle
United Kingdom	Royal United Hospitals Bath /ID# 169084	Bath
United Kingdom	South Eastern Health and Social Care Trust /ID# 205322	Belfast	Antrim
United Kingdom	University Hospitals Birmingham NHS Foundation Trust /ID# 169080	Birmingham
United Kingdom	The Dudley Group NHS Foundation Trust /ID# 169079	Dudley
United Kingdom	London North West University Healthcare NHS Trust /ID# 169078	Harrow
United Kingdom	Barts Health NHS Trust /ID# 218829	London	London, City Of
United Kingdom	King's College Hospital NHS Foundation Trusts /ID# 169082	London
United Kingdom	The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 169085	Newcastle Upon Tyne
United Kingdom	Stockport NHS foundation trust /ID# 208718	Stockport
United Kingdom	Taunton and Somerset NHS Foundation Trust /ID# 209664	Taunton
United Kingdom	St George's University Hospitals NHS Foundation Trust /ID# 205551	Tooting
United Kingdom	Warrington and Halton Hospitals NHS Foundation Trust /ID# 171388	Warrington	Cheshire West And Chester
United Kingdom	Warrington and Halton Hospitals NHS Foundation Trust /ID# 209085	Warrington	Cheshire West And Chester
United Kingdom	The Royal Wolverhampton NHS Trust /ID# 171387	Wolverhampton
United States	University of Michigan Health Systems /ID# 164844	Ann Arbor	Michigan
United States	TX Clinical Research Institute /ID# 164848	Arlington	Texas
United States	Johns Hopkins University School of Medicine /ID# 211940	Baltimore	Maryland
United States	Inquest Clinical Research /ID# 164865	Baytown	Texas
United States	Washington Gastroenterology Associates /ID# 164721	Bellevue	Washington
United States	HP Clinical Research /ID# 164929	Bountiful	Utah
United States	Advantage Clinical Trials /ID# 168557	Bronx	New York
United States	Montefiore Medical Center - Moses Campus /ID# 166226	Bronx	New York
United States	NY Scientific /ID# 164833	Brooklyn	New York
United States	Lahey Hospital and Medical Center /ID# 214725	Burlington	Massachusetts
United States	Texas Digestive Disease Consultants /ID# 209802	Cedar Park	Texas
United States	Texas Digestive Disease Consultants /ID# 209952	Cedar Park	Texas
United States	Delsol Research Management, Ll /Id# 170179	Chandler	Arizona
United States	Pharmacorp Clinical Trials /ID# 164809	Charleston	South Carolina
United States	Atrium Health Carolinas Medical Center /ID# 164834	Charlotte	North Carolina
United States	PMG Research of Charlotte /ID# 171170	Charlotte	North Carolina
United States	Clin Res Inst of Michigan, LLC /ID# 170178	Chesterfield	Michigan
United States	MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 164835	Chevy Chase	Maryland
United States	University of Chicago Medicine /ID# 165472	Chicago	Illinois
United States	Consultants for Clinical Research /ID# 164855	Cincinnati	Ohio
United States	University of Cincinnati /ID# 164720	Cincinnati	Ohio
United States	Clinical Research of West Florida, Inc /ID# 205825	Clearwater	Florida
United States	Clinical Research of West Florida, Inc /ID# 208117	Clearwater	Florida
United States	Cleveland Clinic Main Campus /ID# 208220	Cleveland	Ohio
United States	Delta Waves, Inc. /ID# 164872	Colorado Springs	Colorado
United States	Peak Gastroenterology Associates, PC /ID# 170181	Colorado Springs	Colorado
United States	Gastro Center of Maryland /ID# 171171	Columbia	Maryland
United States	Optimed Research, Ltd. /ID# 205618	Columbus	Ohio
United States	The Ohio State University /ID# 170174	Columbus	Ohio
United States	Advanced Research - Coral Springs /ID# 218020	Coral Springs	Florida
United States	Southern California Res. Ctr. /ID# 169654	Coronado	California
United States	Citrus Valley Gastroenterology /ID# 166201	Covina	California
United States	Tri-State Gastroenterology /ID# 165484	Crestview Hills	Kentucky
United States	Hometown Urgent Care and Resea /ID# 201290	Dayton	Ohio
United States	DuPage Medical Group /ID# 205303	Downers Grove	Illinois
United States	AGA Clinical Research Associates, LLC /ID# 164883	Egg Harbor Township	New Jersey
United States	Dayton Gastroenterology, Inc. /ID# 167624	Englewood	Ohio
United States	MediSphere Medical Research Center /ID# 166209	Evansville	Indiana
United States	Plains Clinical Research Center, LLC /ID# 170184	Fargo	North Dakota
United States	Digestive Health Associates (DHA) - Farmington Hills /ID# 206099	Farmington Hills	Michigan
United States	Gastro One /ID# 164718	Germantown	Tennessee
United States	Gastroenterology Associates, P.A. of Greenville /ID# 164880	Greenville	South Carolina
United States	Medical Research Center of CT /ID# 164829	Hamden	Connecticut
United States	CroNOLA, LLC /ID# 164722	Houma	Louisiana
United States	Baylor College of Medicine - Baylor Medical Center /ID# 164847	Houston	Texas
United States	Centex Studies, Inc. - Houston /ID# 201213	Houston	Texas
United States	CliniCore International, LLC /ID# 164662	Houston	Texas
United States	GI Specialists of Houston /ID# 202338	Houston	Texas
United States	Indianapolis Gastroenterology /ID# 164837	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics /ID# 165330	Iowa City	Iowa
United States	Southern Therapy and Advanced Research (STAR) LLC /ID# 165318	Jackson	Mississippi
United States	Encore Borland-Groover Clinical Research /Id# 203498	Jacksonville	Florida
United States	East Tennessee Research Institute /ID# 203612	Johnson City	Tennessee
United States	NYU Langone Long Island Clinical Research Associates /ID# 164830	Lake Success	New York
United States	Las Vegas Medical Research /ID# 168562	Las Vegas	Nevada
United States	United Medical Doctors /ID# 207452	Los Alamitos	California
United States	Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164887	Los Angeles	California
United States	University of Louisville /ID# 168536	Louisville	Kentucky
United States	University of Louisville /ID# 208093	Louisville	Kentucky
United States	Caprock Gastro Research /ID# 215437	Lubbock	Texas
United States	Gastroenterology Associates of Central Georgia, LLC /ID# 165460	Macon	Georgia
United States	Ctr for Advanced Gastroenterol /ID# 165332	Maitland	Florida
United States	Great Lakes Medical Research, LLC /ID# 202007	Mentor	Ohio
United States	Coral Research Clinic /ID# 164657	Miami	Florida
United States	Crystal Pharmacology Research /ID# 166101	Miami	Florida
United States	Froedtert Memorial Lutheran Hospital /ID# 202286	Milwaukee	Wisconsin
United States	Facey Medical Foundation /ID# 203137	Mission Hills	California
United States	CB Flock Research Corporation /ID# 166220	Mobile	Alabama
United States	East View Medical Research, LLC /ID# 171133	Mobile	Alabama
United States	United Medical Doctors - Murrieta /ID# 164845	Murrieta	California
United States	Quality Medical Research /ID# 205262	Nashville	Tennessee
United States	Vanderbilt University Medical Center /ID# 164846	Nashville	Tennessee
United States	Aquiant Research /ID# 205504	New Albany	Indiana
United States	Rutgers Robert Wood Johnson /ID# 166092	New Brunswick	New Jersey
United States	Nola Research Works, LLC /ID# 164897	New Orleans	Louisiana
United States	Advanced Research Institute, Inc /ID# 164814	New Port Richey	Florida
United States	Columbia Univ Medical Center /ID# 164870	New York	New York
United States	The Mount Sinai Hospital /ID# 170172	New York	New York
United States	Advanced Research Institute /ID# 164866	Ogden	Utah
United States	Digestive Disease Specialists /ID# 201062	Oklahoma City	Oklahoma
United States	CHI Health Research Center /ID# 168545	Omaha	Nebraska
United States	Quality Clinical Research Inc. /ID# 170177	Omaha	Nebraska
United States	Endoscopic Research, Inc. /ID# 205893	Orlando	Florida
United States	Omega Research Maitland, LLC /ID# 203480	Orlando	Florida
United States	Thomas Jefferson University /ID# 168014	Philadelphia	Pennsylvania
United States	University of Pennsylvania /ID# 168402	Philadelphia	Pennsylvania
United States	Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 164663	Raleigh	North Carolina
United States	Rapid City Medical Center - GI Research /ID# 201734	Rapid City	South Dakota
United States	Gastro Group of Rochester /ID# 166216	Rochester	New York
United States	Mayo Clinic - Rochester /ID# 164868	Rochester	Minnesota
United States	Gastroenterology Consultants PC - Roswell /ID# 218219	Roswell	Georgia
United States	Duplicate_Care Access Research /ID# 164853	Salt Lake City	Utah
United States	Clinical Associates in Research Therapeutics of America, LLC /ID# 164863	San Antonio	Texas
United States	Southern Star Research Institute, LLC /ID# 169754	San Antonio	Texas
United States	Medical Assoc Research Grp /ID# 169705	San Diego	California
United States	Ucsd /Id# 164679	San Diego	California
United States	UCSF Center for Colitis and Crohn's Disease /ID# 202373	San Francisco	California
United States	Univ of California San Francis /ID# 164843	San Francisco	California
United States	Care Access Research /ID# 167766	San Pablo	California
United States	HonorHealth Research Institute - Shea /ID# 164734	Scottsdale	Arizona
United States	University of Washington /ID# 164875	Seattle	Washington
United States	Virginia Mason - Seattle Orthapedics /ID# 164680	Seattle	Washington
United States	Louisana Research Center, LLC /ID# 164659	Shreveport	Louisiana
United States	Richmond University Medical Center /ID# 201855	Staten Island	New York
United States	Carl R. Meisner Medical Clinic /ID# 201060	Sugar Land	Texas
United States	Arizona Arthritis & Rheumatology Research, PLLC /ID# 203891	Sun City	Arizona
United States	Atlanta Gastroenterology Spec /ID# 164780	Suwanee	Georgia
United States	AdventHealth Tampa /ID# 171175	Tampa	Florida
United States	Clinical Research Trials of Florida, Inc. /ID# 203484	Tampa	Florida
United States	Center for Digestive Health /ID# 164733	Troy	Michigan
United States	Healthcare Research Consultant /ID# 166228	Tulsa	Oklahoma
United States	Options Health Research, LLC /ID# 164737	Tulsa	Oklahoma
United States	Tyler Research Institute, LLC /ID# 168681	Tyler	Texas
United States	The Vancouver Clinic, INC. PS /ID# 164811	Vancouver	Washington
United States	Gastro Health & Nutrition - Victoria /ID# 167813	Victoria	Texas
United States	Allegiance Research Specialists /ID# 165321	Wauwatosa	Wisconsin
United States	Velocity Clinical Research - Salt Lake City /ID# 166095	West Jordan	Utah
United States	Duplicate_Western States Clinical Research, Inc. /ID# 164895	Wheat Ridge	Colorado
United States	Wake Forest Baptist Medical Center /ID# 201225	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI) at Week 12	The CDAI was used to evaluate the activity of Crohn's disease. Clinical remission per CDAI is defined as CDAI <150. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to about 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C).	Week 12
Primary	Percentage of Participants With Endoscopic Response at Week 12	Endoscopic response was defined as greater than 50% decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) from Baseline of the induction study (or for participants with an SES-CD of 4 at Baseline of the induction study, at least a 2-point reduction from Baseline), as scored by Central Reviewer. SES-CD is calculated based on the sum of individual segment values for four endoscopic variables (presence and size of ulcers, ulcerated surface, affected surface and presence of narrowing). Each variable in each segment is scored 0 to 3 resulting in SES-CD values ranging from 0 to 56 with higher scores indicating more severe disease. Results were based on NRI-C.	Baseline to Week 12
Primary	Number of Participants With Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product.	From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
Secondary	Percentage of Participants With Clinical Remission Per Patient-Reported Outcomes (PROs) at Week 12	Clinical remission per PROs was defined as average daily very soft or liquid stool frequency (SF) =2.8 and average daily abdominal pain (AP) score =1.0 and both not greater than Baseline. The number of soft or liquid stools and abdominal pain rated on a scale of 0=none to 3=severe were recorded in an electronic diary. Results were based on NRI-C.	Baseline to Week 12
Secondary	Percentage of Participants With Endoscopic Remission at Week 12	Endoscopic remission was defined per SES-CD. SES-CD =4 and at least 2-point reduction from Baseline and no subscore >1 in any individual variable, as scored by Central Reviewer. SES-CD is calculated based on the sum of individual segment values for four endoscopic variables (presence and size of ulcers, ulcerated surface, affected surface and presence of narrowing). Each variable in each segment is scored 0 to 3 resulting in SES-CD values ranging from 0 to 56 with higher scores indicating more severe disease. Results were based on NRI-C.	Baseline to Week 12
Secondary	Percentage of Participants Who Discontinued Corticosteroid Use for Crohn's Disease (CD) and Achieved Clinical Remission Per CDAI at Week 12, in Participants Taking Corticosteroids at Baseline	As prespecified in the protocol, this outcome measure was planned to be assessed in participants taking corticosteroids at Baseline. Clinical remission per CDAI: CDAI <150. The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to about 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on NRI-C.	Week 12
Secondary	Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Week 12	The FACIT-F questionnaire was developed to assess fatigue associated with anemia. It consists of 13 fatigue-related questions. The responses to the 13 items on the FACIT-F questionnaire are each measured on a 5-point Likert scale. The responses to the answers are the following: 0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4=very much. Thus, the total score ranges from 0 to 52. High scores represent less fatigue. A positive change from Baseline indicates improvement.	Baseline and Week 12
Secondary	Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12	The IBDQ is a disease-specific instrument composed of 32 Likert-scaled items. The IBDQ scale contains 4 component subscales: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items), and social function(5 items). Each item is scored on a 7-point scale where: 1=worst to 7= best. The total score ranges from 32 to 224, with higher scores indicating better health-related quality of life. A positive change from Baseline indicates improvement.	Baseline and Week 12
Secondary	Percentage of Participants Achieving Clinical Response 100 (CR-100) at Week 2	CR-100 is defined as a decrease of at least 100 points in CDAI from Baseline at Week 2. The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to about 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on NRI-C.	Baseline to Week 2
Secondary	Percentage of Participants Achieving Clinical Response 100 (CR-100) at Week 12	CR-100 is defined as a decrease of at least 100 points in CDAI from Baseline at Week 12. The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to about 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on NRI-C.	Baseline to Week 12
Secondary	Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI) at Week 4	The CDAI was used to evaluate the activity of Crohn's disease. Clinical remission per CDAI is defined as CDAI <150. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on NRI-C.	Week 4
Secondary	Percentage of Participants With Hospitalizations Due to Crohn's Disease (CD) During Part 1 (12-week Double-blind Induction Period)		Up to Week 12 in Part 1: Double-blind Induction Period
Secondary	Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs) at Week 12, in Participants With EIMs at Baseline	EIMs are defined as manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver. Results were based on NRI-C.	Week 12

External Links

•   RINVOQ® (upadacitinib) extended-release tablets prescribing information