Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease

Crohn's Disease Clinical Trial

— DIVERSITY1  

Official title:

Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02914561
• Other study ID #: GS-US-419-3895
• Secondary ID: 2016-001367-36
• Status: Completed
• Phase: Phase 3
• Start date: October 31, 2016
• Est. completion date: November 11, 2022

Study information

• Verified date: November 2023
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced.

Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Study GS-US-419-3896).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1372
• Est. completion date: November 11, 2022
• Est. primary completion date: November 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Key Inclusion Criteria:

• Documented diagnosis of CD with a minimum disease duration of 3 months with involvement of the ileum and/or colon at a minimum, as determined by histopathology and endoscopic assessment

• Moderately to severely active CD

• Cohort A (Biologic Naïve): Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): corticosteroids and immunomodulators

• Cohort A (Biologic Experienced): Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines) or discontinuation of use of at least one of the following agents for reasons other than inadequate clinical response, loss of response or intolerance: tumor necrosis factor alpha (TNFa) antagonists, vedolizumab, and ustekinumab

• Cohort B (Biologic Experienced): Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): TNFa antagonists, vedolizumab, and ustekinumab

Key Exclusion Criteria:

• Current complications of CD such as symptomatic strictures, severe rectal/anal stenosis, fistulae other than perianal fistulae, short bowel syndrome, etc.

• Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon

• Active tuberculosis (TB) or history of latent TB that has not been treated

• Use of any prohibited concomitant medications as described in the study protocol

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Filgotinib
Filgotinib tablets administered orally once daily.

Other:
• Placebo
Placebo administered orally once daily.

Locations

Country	Name	City	State
Argentina	Fundacion Estudios Clinicos CiRec	Rosario
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	Emeritus Research	Camberwell	Victoria
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Monash Medical Centre	Clayton	New South Wales
Australia	St. Vincent's Hospital Sydney	Darlinghurst	New South Wales
Australia	Footscray Hospital	Footscray	Victoria
Australia	Austin Health	Heidelberg	Victoria
Australia	Nepean Hospital	Kingswood	New South Wales
Australia	Cabrini Hospital	Malvern	Victoria
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Coastal Digestive Health	Mountain Creek	Queensland
Australia	Coral Sea Clinical Research Institute (Mackay)	North Mackay	Queensland
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	Mater Misericordiae Ltd	South Brisbane	Queensland
Australia	Wollongong Hospital	Wollongong	New South Wales
Australia	The Queen Elizabeth Hospital	Woodville South	South Australia
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Austria	Universitatsklinik Innsbruck	Innsbruck
Austria	AKH-Medizinische Universitat Wien	Wien
Belgium	GZA Ziekenhuizen campus Sint-Vincentius	Antwerpen
Belgium	Imelda General Hospital	Bonheiden
Belgium	CUB Hopital Erasme	Brussel
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Universitair Ziekenhuis Leuven	Leuven
Belgium	CHR Citadelle	Liege
Belgium	Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph	Liège
Belgium	AZ Delta Campus Wilgenstraat	Roeselare
Bulgaria	Medical Center - Complete Medical Solutions OOD	Samokov
Bulgaria	Medical Center - "Tsaritsa Yoanna" EOOD	Sliven
Bulgaria	"MDHAT Dr. St.Cherkezov" AD	Veliko Tarnovo
Bulgaria	MHAT "Sveta Petka" AD	Vidin
Canada	Barrie GI Associates	Barrie
Canada	University of Calgary, Heritage Medical Research Clinic	Calgary
Canada	Hamilton Health Sciences Corporation, McMaster University Medical Centre	Hamilton
Canada	London Health Sciences Centre - University Hospital	London
Canada	TIDHI Innovation Inc.	North York
Canada	ABP Research Services	Oakville
Canada	Royal University Hospital	Saskatoon
Canada	The Gordon and Leslie Diamond Health Care Centre	Vancouver
Canada	Toronto Digestive Disease Associates Inc.	Vaughan
Canada	Percuro Clinical Research Ltd.	Victoria
Croatia	University Hospital Center Osijek	Osijek
Croatia	Clinical Hospital Dubrava	Zagreb
Croatia	University Hospital Center Zagreb	Zagreb
Czechia	Hepato-Gastroenterologie HK, s.r.o.	Hradec Kralove
Czechia	Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni	Mlada Boleslav
Czechia	G.E.P. Clinic, s r.o.	Praha 3
Czechia	Thomayerova nemocnice, Interni klinika 3. LF UK a TN (Interni Oddeleni)	Praha 4
Czechia	ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zanety	Praha 9
France	CHU Amiens Picardie	Amiens Cedex 1
France	CHU de Caen	Caen Cedex 9
France	CHU de Clermont-Ferrand - Hopital d'Estaing	Clermont-Ferrand
France	APHP - Hopital Beaujon - Clichy - Universite Paris VII	Clichy
France	Centre Hospitalier Intercommunal de Creteil	Créteil
France	CHU de Dijon Bourgogne - Hopital Francois Mitterand	Dijon
France	CHU Grenoble Alpes	La Tronche
France	Hopital Universitaire de Bicetre	Le Kremlin Bicetre
France	Centre Hospitalier Regional Universitaire de Lille	Lille
France	Hopital Nord	Marseille
France	Hopital Saint Joseph	Marseille
France	CHU de Montpellier-Hopital Saint Eloi	Montpellier
France	Centre d'Investigation Clinique - CHU Hotel-Dieu	Nantes
France	Hopital de l'Archet 2	Nice
France	CHU de Bordeaux - Hopital Haut Leveque	Pessac
France	Centre Hospitalier Universitaire de Lyon Sud	Pierre-Benite
France	CH Annecy Genevois - Site d'Annecy	Pringy Cedex
France	Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou	Rennes Cedex 9
France	CHU de Saint-Etienne - Hopital Nord	Saint Priest en Jarez
France	Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre	Strasbourg
France	Nouvel Hopital Civil	Strasbourg
France	CHU de Toulouse - Hopital Rangueil	Toulouse
France	CHU de Toulouse - Hopital Rangueil	Toulouse Cedex 9
France	CHU de Nancy - Hopital Brabois Adultes	Vandoeuvre-les-Nancy Cedex
Georgia	Unimed Ajara LLC - Batumi Referral Hospital	Batumi
Georgia	Medi Club Georgia LLC	Tbilisi
Georgia	Ltd. Unimed Kakheti - Telavi Referral Hospital	Telavi
Germany	Charite - Universitatsmedizin Berlin	Berlin
Germany	Charite Universitaetsmedizin Berlin	Berlin
Germany	DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin	Berlin
Germany	Gastro-Studien	Berlin
Germany	Stadtisches Klinikum Braunschweig gGmbH	Braunschweig
Germany	Agaplesion Markus Krankenhaus	Frankfurt am Main
Germany	CED Studien UG, Interdisciplinary Crohn Colitis Center (iCCC) Rhein-Main	Frankfurt am Main
Germany	Universitatsklinikum Freiburg	Freiburg
Germany	Asklepios Westklinikum Hamburg	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Praxis fur Gastroenterologie	Heidelberg
Germany	Universitatsklinikum Heidelberg	Heidelberg
Germany	Gastroenterologische Gemeinschaftspraxis Herne	Herne
Germany	Universitatsklinikum Jena	Jena
Germany	Universitatsklinikum Schleswig-Holstein	Kiel
Germany	Universitatsklinik Koln	Koln
Germany	EUGASTRO GmbH	Leipzig
Germany	Universitatsklinikum Leipzig	Leipzig
Germany	Klinikum Luneburg	Lüneburg
Germany	Gastroenterologische Gemeinschaftspraxis Minden	Minden
Germany	Klinikum der Universitat Munchen - Grosshadern	Muenchen
Germany	Universitaetsmedizin Rostock, Zentrum fuer Innere Medizin	Rostock
Germany	Universitaetsklinikum Tuebingen	Tuebingen
Germany	Universitatsklinikum Ulm, Zentrum Fur Innere Medizin	Ulm
Greece	General Hospital of Athens "Hippokratio", 2nd Internal Medicine Clinic of Athens University, Hepato-gastroenterology Unit	Athens
Greece	University General Hospital "Attikon", 2nd Propaedeutic Internal Medicine Dept. and Research Unit, Hepatogastroenterology Unit	Athens
Greece	University General Hospital of Ioannina, Gastroenterology Department, Internal Medicine Division	Ioannina
Greece	University General Hospital of Patras "Panagia I Voithia", Gastroenterology Department, Internal Medicine Division	Patras
Greece	General Hospital of Thessaloniki "Hippokratio", 4th Internal Medicine Department of Aristotle University of Thessaloniki	Thessaloniki
Hong Kong	Princess Margaret Hospital	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital	Shatin
Hong Kong	Tuen Mun Hospital	Tuen Mun
Hungary	Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia	Bekescsaba
Hungary	Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.	Budapest
Hungary	Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo	Budapest
Hungary	Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly	Budapest
Hungary	Szent Margit Korhaz, Gasztroenterológiai Osztály	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia	Debrecen
Hungary	Bugat Pal Korhaz, Belgyogyaszat	Gyöngyös
Hungary	Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia	Mosonmagyarovar
Iceland	Landspitali University Hospital	Reykjavik
India	Gastroplus Digestive Disease Centre Pvt Ltd	Ahmedabad
India	Kaizen Hospital	Ahmedabad
India	Sal Hospital and Medical Institute	Ahmedabad
India	M S Ramaiah Medical College and Hospital	Bangalore
India	Victoria Hospital, Bangalore Medical College and Research Institute	Bangalore
India	KLES Dr. Prabhakar Kore Hospital & MRC	Belgaum
India	BGS Global Hospital	Bengaluru
India	S.P. Medical College & AG of Hospitals	Bikaner	Rajasthan
India	Apollo Speciality Hospital	Chennai
India	VGM Hospital Institute of Gastroenterology	Coimbatore
India	Maharaja Agrasen Hospital	Delhi
India	Lourdes Hospital	Ernakulam
India	PVS Memorial Hospital Private Limited	Ernakulam
India	Fortis Medical Research Institute	Gurgaon
India	Institute of Digestive & Liver Diseases	Guwahati
India	Asian Institute of Gastroenterology Pvt Ltd	Hyderabad
India	Aware Gleneagles Global Hospitals	Hyderabad
India	Centre for Liver Research & Diagnostics	Hyderabad
India	Citizens Specialty Hospital	Hyderabad
India	Gleneagles Global Hospitals	Hyderabad
India	S.M.S Medical College & Hospitals	Jaipur
India	S.R.Kalla Memorial Gastro.&General Hospital	Jaipur
India	GSVM Medical College	Kanpur
India	Amrita Institute of Medical Sciences and Research Centre	Kochi
India	Lakeshore Hospital and Research Centre Ltd.	Kochi
India	Apollo Gleneagles Hospitals	Kolkata
India	School of Digestive & Liver Diseases	Kolkata
India	King George's Medical University	Lucknow
India	Dayanand Medical College & Hospital	Ludhiana
India	Kasturba Medical College (KMC) Hospital	Mangaluru
India	Lokmanya Tilak Municipal General Hospital	Mumbai
India	Seth G.S Medical College & KEM Hospital	Mumbai
India	Midas Multispeciality Hospital Pvt. Ltd	Nagpur
India	Suretech Hospital & Research Centre Ltd	Nagpur
India	All India Institute of Medical Sciences	New Delhi
India	Dr. B.L. Kapur Memorial Hospital	New Delhi
India	Fortis Flt. Lt. Rajan Dhall Hospital	New Delhi
India	Max Smart Super Speciality Hospital	New Delhi
India	S.L Raheja Hospital	Parel
India	Department of Surgery, B.J. Government Medical College & Sassoon General Hospital	Pune
India	Grant Medical Foundation Ruby Hall Clinic	Pune
India	Universal Hospital	Pune
India	Shree Giriraj Multispeciality Hospital	Rajkot
India	Gandhi Hospital	Secunderabad
India	Institute of Gastroenterology & Liver Disease. Sunshine Hospitals	Secunderabad
India	BAPS Pramukh Swami Hospital	Surat
India	Surat Institute of Digestive Sciences	Surat
India	Kasturba Hospital Medical College	Udupi
India	Sterling Hospital	Vadodara
India	Samvedna Hospital	Varanasi
Ireland	Beaumont Hospital	Dublin
Ireland	St. Vincent's University Hospital	Dublin
Ireland	Wellcome Trust HRB Clinical Research Facility	Dublin
Ireland	University Hospital Galway	Galway
Israel	Emek Medical Center	Afula
Israel	Soroka Medical Center	Be'er Sheva
Israel	Bnai Zion Medical Center	Haifa
Israel	Rambam Health Care Campus	Haifa
Israel	The Edith Wolfson Medical Center	Holon
Israel	Hadassah Medical Center	Jerusalem
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Meir Medical Center	Kefar Sava
Israel	Rabin Medical Center	Petah Tikva
Israel	The Chaim Sheba Medical Center	Ramat Gan
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv-Yafo
Italy	UOC Gastroenterologia II	Castellana Grotte
Italy	U.O. Fisiopatologia Digestiva	Catanzaro
Italy	UOC Medicina Interna	Cento
Italy	Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina	Chieti
Italy	Gastroenterologia clinica - Azienda Ospedaliero-Universitaria Careggi	Firenze
Italy	Endoscopia Digestiva Centralizzata	Milano
Italy	UO Gastroenterologia	Modena
Italy	UOC Gastroenterologia	Padova
Italy	Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello	Pisa
Italy	UOC di Gastroenterologia ed Endoscopia Digestiva	Roma
Italy	Istituto Clinico Humanitas	Rozzano
Italy	A.O. Ordine Mauriziano di Torino	Torino
Japan	Ohmori Toshihide gastro-intestinal Clinic	Ageo-shi
Japan	Tokyo Medical and Dental University Hospital	Bunkyo-ku
Japan	Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital	Chuo-ku
Japan	Japanese Red Cross Fukuoka Hospital	Fukuoka-shi
Japan	Tokai University Hachioji Hospital	Hachioji
Japan	Medical corporation Ryowakai, Hamamatsu South Hospital	Hamamatsu-shi
Japan	Hiroshima University Hospital	Hiroshima
Japan	Hiroshima Prefectural Hospital	Hiroshima-shi
Japan	Fukuoka University Hospital	Jonan-ku
Japan	Nanpuh Hospital	Kagoshima-shi
Japan	Ofuna Chuo Hospital	Kamakura
Japan	Tsujinaka Hospital	Kashiwa-city
Japan	Saitama Medical Center, Saitama Medical University	Kawagoe
Japan	Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center	Kitakyushu-shi
Japan	Yamanashi Prefectural Central Hospital	Kofu-shi
Japan	Hidaka Coloproctology Clinic	Kurume-shi
Japan	Kurume University Hospital	Kurume-shi
Japan	University Hospital, Kyoto Prefectural University of Medicine	Kyoto-shi
Japan	Kitasato University Kitasato Institute Hospital	Minato-ku
Japan	The Jikei University Hospital	Minato-ku
Japan	Kyorin University Hospital	Mitaka-shi
Japan	Iwate Medical University Hospital	Morioka-shi
Japan	Aichi Medical University Hospital	Nagakute-shi
Japan	Nagasaki University Hospital	Nagasaki-shi
Japan	Nagoya City University Hospital	Nagoya
Japan	Saiseikai Niigata Daini Hospital	Nishi-ku
Japan	Hyogo College of Medicine College Hospital	Nishinomiya
Japan	Ishida IBD Clinic	Oita-shi
Japan	Okayama University Hospital	Okayama-city
Japan	Osaka City University Hospital	Osaka
Japan	Wakakusa-Daiichi Hospital	Osaka
Japan	Kinshukai Infusion Clinic	Osaka-City
Japan	Shiga University of Medical Science Hospital	Otsu
Japan	Saga University Hospital	Saga
Japan	Saga-Ken Medical Centre Koseikan	Saga-shi
Japan	Kitasato University Hospital, THE KITASATO INSTITUTE	Sagamihara
Japan	Tokito Clinic	Saitama
Japan	Toho University Sakura Medical Center	Sakura
Japan	Sapporo Tokushukai Hospital	Sapporo
Japan	Sapporo Higashi Tokushukai Hospital	Sapporo-shi
Japan	National Hospital Organization Sendai Medical Center	Sendai
Japan	Tokyo Yamate Medical Center	Shinjuku-ku
Japan	Osaka University Hospital	Suita
Japan	Kagawa Prefectural Central Hospital	Takamatsu-shi
Japan	National Hospital Organization Takasaki General Medical Center	Takasaki-shi
Japan	Osaka Medical College Hospital	Takatsuki
Japan	Ieda Hospital	Toyota-shi
Japan	Wakayama Medical University Hospital	Wakayama-shi
Japan	Yokohama Health Medicine Association Kannai Suzuki Clinic	Yokohama-shi
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Yeungnam University Hospital	Daegu
Korea, Republic of	Kyung Hee University Hospital	Guri-Si
Korea, Republic of	Hanyang University Guri Hospital	Gyeonggi-do
Korea, Republic of	CHA Bundang Medical Center, CHA University	Seongnam-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Division of Gastroenterology, Department of Medicine, Samsung Medical Center	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, St. Vincent's Hospital	Suwon-si
Korea, Republic of	Yonsei University Wonju Severance Christian Hospital	Wonju
Malaysia	Universiti Kebangsaan Malaysia Medical Center	Cheras
Malaysia	Hospital Pulau Pinang	George Town
Malaysia	Hospital Queen Elizabeth	Kota Kinabalu
Malaysia	University Malaya Medical Centre	Kuala Lumpur
Malaysia	Hospital Tengku Ampuan Afzan	Kuantan
Netherlands	NZW Alkmaar (Noordwest Ziekenhuisgroep)	Alkmaar
Netherlands	Academic Medical Center (AMC)	Amsterdam
Netherlands	VU University Medical Centre	Amsterdam
Netherlands	Gelre Hospital	Apeldoorn
Netherlands	University Medical Center Groningen (UMCG)	Groningen
Netherlands	Maastricht University Medical Centre	Maastricht
Netherlands	Erasmus University Medical Center	Rotterdam
Netherlands	Elisabeth-TweeSteden Hospital	Tilburg
Netherlands	University Medical Center Utrecht	Utrecht
New Zealand	Christchurch Hospital	Christchurch
New Zealand	Southern District Health Board - Dunedin Hospital	Dunedin
New Zealand	Auckland City Hospital	Grafton
New Zealand	Waikato Hospital	Hamilton
New Zealand	Wellington Hospital	Newtown
New Zealand	Bay of Plenty District Health Board - Tauranga Hospital	Tauranga
New Zealand	Hutt Valley District Health Board - Hutt Valley Hospital	Wellington
Norway	Vestre Viken Hospital Trust, Baerum Hospital	Drammen
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych	Bialystok
Poland	Gabinet Lekarski Janusz Rudzinski	Bydgoszcz
Poland	Szpital Uniwersytecki nr 2 im. Dr. Jana Biziela w Bydgoszczy, Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych	Bydgoszcz
Poland	VITAMED Galaj i Cichomski spolka jawna	Bydgoszcz
Poland	NZOZ INTER-MED, Centrum Endoskopowe	Czestochowa
Poland	Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS	Katowice
Poland	Gabinet Endoskopii Przewodu Pokarmowego	Krakow
Poland	Centrum Medyczno-Diagnostyczne Prima-Med	Kraków
Poland	Krakowskie Centrum Medyczne Sp. z o.o.	Kraków
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwerstyeckiego Szpitala Klinicznego nr 1 im. Norbert Barlickiego	Lodz
Poland	Trialmed Crs	Piotrków Trybunalski
Poland	Clinical Research Center Spolka z ograniczna odpowiedzialnoscia Medic-R Sp. k.	Poznan
Poland	Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski	Rzeszów
Poland	Endoskopia Sp. Z o.o.	Sopot
Poland	Twoja Przychodnia-Szczecinskie Centrum Medyczne	Szczecin
Poland	GASTROMED Kopon, Zmudzkinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii	Torun
Poland	H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K.	Tychy
Poland	Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie	Warsaw
Poland	Bodyclinic	Warszawa
Poland	Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie	Warszawa
Poland	Centrum Zdrowia MDM	Warszawa
Poland	Medical Concierge Centrum Medyczne	Warszawa
Poland	Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz	Warszawa
Poland	WIP Warsaw IBD Point Profesor Kierkus	Warszawa
Poland	Centrum Medyczne	Wroclaw
Poland	Centrum Medyczne Oporow	Wroclaw
Portugal	Hospital de Braga	Braga
Portugal	Centro Hospitalar e Universitario de Coimbra, E.P.E.	Coimbra
Portugal	Centro Hospitalar Cova de Beira, EPE	Covilhã
Portugal	Centro Hospitalar do Algarve EPE	Faro
Portugal	Hospital da Senhora da Oliveira Guimaraes, E.P.E.	Guimaraes
Portugal	Hospital Beatriz Angelo	Loures
Portugal	Centro Hospitalar de Sao Joao, EPE	Porto
Portugal	Unidade Local de Saude do Alto Minho, EPE	Viana do Castelo
Romania	S.C. Centrul Medical Sana S.R.L., Gastroenterologie	Bucharest
Romania	Spitalul Universitar de Urgenta Bucuresti - Sectia Medicina Interna II	Bucharest
Romania	Delta Health Care/ Ponderas Academic Hospital	Bucuresti
Romania	MedLife, Gastroenterologie	Bucuresti
Romania	SC MedLife SA, Gastroenterologie	Bucuresti
Romania	Spitalul Clinic Colentina, Gastroenterologie	Bucuresti
Romania	Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila - Sectia Clinica de Gastroenterologie	Bucuresti
Romania	Gastromedica SRL, Gastroenterologie	Iasi
Romania	Cabinet Particular Policlinic Algomed SRL	Timisoara
Romania	Centrul Medical Tuculanu, Gastroenterologie	Timisoara
Romania	S.C. Policlinica Dr. Citu S.R.L.- Gastroenterologie	Timisoara
Russian Federation	State Budgetary Healthcare Institute "Chelyabinsk Regional Clinical Hospital"	Chelyabinsk
Russian Federation	State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital	Irkutsk
Russian Federation	State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow"	Moscow
Russian Federation	State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy"	Moscow
Russian Federation	State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A.	Nizhniy Novgorod
Russian Federation	State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"	Novosibirsk
Russian Federation	State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12"	Novosibirsk
Russian Federation	"PolyClinic EXPERT" LLC	Saint-Petersburg
Russian Federation	"Scientific Research Centre ECO-safety" LLC	Saint-Petersburg
Russian Federation	Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38"	Saint-Petersburg
Russian Federation	State Healthcare Institution "Regional Clinical Hospital"	Saratov
Serbia	Clinical Center of Serbia	Belgrade
Serbia	Clinical Hospital Center Zemun	Belgrade
Serbia	University Hospital Medical Center Bezanijska kosa	Belgrade
Serbia	Zvezdara University Medical Center	Belgrade
Serbia	Clinical Center of Vojvodina	Novi Sad
Singapore	Changi General Hospital	Singapore
Singapore	National University Hospital	Singapore
Singapore	Singapore General Hospital	Singapore
Singapore	Tan Tock Seng Hospital	Singapore
Slovakia	Cliniq s. r. o., Gastroenterologicke centrum Ruzinov	Bratislava
Slovakia	KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra	Nitra
Slovakia	Gastro I., s.r.o.	Presov
South Africa	Dr John P Wright	Cape Town
South Africa	Dr MJ Prins	Cape Town
South Africa	Peermed Clinical Trial Centre	Johannesburg
Spain	Hospital Universitari Germans Trias i Pujol	Badalona
Spain	Centro Medico Teknon	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Complejo Hospitalario Universitario de Ferrol	Ferrol
Spain	Hospital Universitario de Gran Canaria "Dr. Negrin"	Las Palmas de Gran Canaria
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Spain	Hospital Universitario de Fuenlabrada	Madrid
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Complejo Hospitalario Universitario de Pontevedra	Pontevedra
Spain	Hospital de Sagunto	Sagunto
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Hospital de Galdakao-Usandolo	Usansolo
Sri Lanka	National Hospital of Sri Lanka	Colombo
Sri Lanka	Teaching hospital Karapitiya	Galle
Sri Lanka	Kandy Teaching Hospital	Kandy
Sri Lanka	Colombo North Teaching Hospital	Ragama
Sweden	Danderyds Sjukhus AB	Danderyd
Sweden	Akademiska Sjukhuset	Uppsala
Switzerland	Gastroenterologische Praxis Balsiger, Seibold und Partner	Bern
Switzerland	Universitatsspital Zurich	Zurich
Taiwan	Changhua Christian Hospital	Changhua
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Far Eastern Memorial Hospital	New Taipei City
Taiwan	Chang Shan Medical University Hospital	Taichung
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan City
Taiwan	Mackay Memorial Hospital, Taipei	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch	Taoyuan
Ukraine	Bukovinian State Medical University	Chernivtsi
Ukraine	Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. Danylo Halytsky Lviv National Medical	Chernivtsi
Ukraine	State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"	Dnipropetrovsk
Ukraine	Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National	Ivano-Frankivsk
Ukraine	Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department	Kharkiv
Ukraine	Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1	Kharkiv
Ukraine	Treatment and Diagnostic Center of Private Enterprise of Private Production Company "Acinus"	Kropyvnytskyi
Ukraine	Kyiv City Clinical Hospital No. 18, Proctology Department	Kyiv
Ukraine	Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department	Kyiv
Ukraine	Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department	Odessa
Ukraine	Ternopil University Hospital, Regional Center of Gastroenterology with Hepatology	Ternopil
Ukraine	Municipal Institution "Uzhgorod District Hospital", Therapy Department	Uzhgorod
Ukraine	M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department	Vinnytsia
Ukraine	Medical Center LLC "Health Clinic"	Vinnytsia
Ukraine	Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1	Vinnytsia
Ukraine	Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council	Zaporizhzhya
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	The Pennine Acute Hospitals NHS Trust	Bury
United Kingdom	Cambridge University Hospital NHS Foundation Trust	Cambridge
United Kingdom	Royal Derby Hospital	Derby
United Kingdom	NHS Lothian	Edinburgh
United Kingdom	Medical Outpatient Department	Exeter
United Kingdom	Glasgow Clinical Research Facility - Queen Elizabeth University Hospital	Glasgow
United Kingdom	NHS Greater Glasgow and Clyde	Glasgow
United Kingdom	Wycombe Hospital	High Wycombe
United Kingdom	Hull Royal Infirmary	Hull
United Kingdom	Imperial College Healthcare NHS Trust, St Mary's Hospital	London
United Kingdom	Norfolk and Norwich University Hospital NHS Foundation Trust	Norwich	Norfolk
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford
United Kingdom	St Helens and Knowsley Teaching Hospitals NHS Trust	Prescot
United Kingdom	Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility	Southampton
United States	Investigative Clinical Research	Annapolis	Maryland
United States	Texas Clinical Research Institute	Arlington	Texas
United States	Illinois Gastroenterology Group - Arlington Heights	Arlington Heights	Illinois
United States	University of Colorado Denver and Hospital	Aurora	Colorado
United States	Pinnacle Clinical Research	Austin	Texas
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Inquest Clinical Research	Baytown	Texas
United States	Massachusetts General Hospital - Crohn's and Colitis Center	Boston	Massachusetts
United States	HP Clinical Research	Bountiful	Utah
United States	NY Scientific	Brooklyn	New York
United States	Charlotte Gastroenterology & Hepatology, PLLC	Charlotte	North Carolina
United States	Charlottesville Medical Research Center, LLC	Charlottesville	Virginia
United States	University of Virginia Health System	Charlottesville	Virginia
United States	WR-ClinSearch, LLC	Chattanooga	Tennessee
United States	Gastroenterology Associates of Tidewater	Chesapeake	Virginia
United States	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan
United States	MGG Group Co., Inc., Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	Northwestern University, Feinberg School of Medicine	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Consultants for Clinical Research	Cincinnati	Ohio
United States	UC Health Physicians Clifton	Cincinnati	Ohio
United States	Gastro Center of Maryland	Columbia	Maryland
United States	Advanced Research, LLC	Coral Springs	Florida
United States	Southern California Research Center, Inc.	Coronado	California
United States	Digestive Health Specialists of the Southeast	Dothan	Alabama
United States	AGA Clinical Research Associates, LLC	Egg Harbor Township	New Jersey
United States	Fargo Gastroenterology and Hepatology Clinic	Fargo	North Dakota
United States	Connecticut GI, PC-Research Division	Farmington	Connecticut
United States	San Antonio Military Medical Center	Fort Sam Houston	Texas
United States	UF Clinical Research Center	Gainesville	Florida
United States	VVCRD Research	Garden Grove	California
United States	DHAT Research Institute	Garland	Texas
United States	Gastro One	Germantown	Tennessee
United States	Spectrum Health Butterworth Hospital	Grand Rapids	Michigan
United States	NYU Langone Long Island Clinical Research Associates	Great Neck	New York
United States	Illinois Gastroenterology Group - Gurnee	Gurnee	Illinois
United States	Meritus Center for Clinical Research	Hagerstown	Maryland
United States	Great Lakes Medical Research, LLC	Harrisburg	Pennsylvania
United States	Baylor College of Medicine- Baylor Medical Center	Houston	Texas
United States	Centex Studies, Inc.	Houston	Texas
United States	Gulf Coast Research Group	Houston	Texas
United States	Kelsey-Seybold Clinic	Houston	Texas
United States	The Methodist Hospital	Houston	Texas
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	Indiana University Health University Hospital	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Kansas City Research Institute	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	UC San Diego Health System	La Jolla	California
United States	Florida Research Institute	Lakewood Ranch	Florida
United States	Florida Center for Gastroenterology	Largo	Florida
United States	Las Vegas Medical Research	Las Vegas	Nevada
United States	Emeritas Research Group LLC	Leesburg	Virginia
United States	South Denver Gastroenterology, PC	Lone Tree	Colorado
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	University of Louisville, School of Medicine	Louisville	Kentucky
United States	Gastroenterology Associates of Central Georgia, LLC	Macon	Georgia
United States	University of Wisconsin Hospital & Clinics	Madison	Wisconsin
United States	Gastrointestinal Specialists of Georgia	Marietta	Georgia
United States	Great Lakes Gastroenterology Research, LLC,	Mentor	Ohio
United States	Advanced Pharma CR	Miami	Florida
United States	Cordova Research Institute	Miami	Florida
United States	University of Miami Crohn's and Colitis Center	Miami	Florida
United States	Vista Health Research, LLC	Miami	Florida
United States	Paramount Medical Research & Consulting, LLC	Middleburg Heights	Ohio
United States	Wisconsin Center for Advanced Research, a division of GI Associates, LLC	Milwaukee	Wisconsin
United States	Delta Research Partners, LLC	Monroe	Louisiana
United States	Gastroenterology Group of Naples	Naples	Florida
United States	Quality Medical Research	Nashville	Tennessee
United States	Vanderbilt University Medical Center - IBD Clinic	Nashville	Tennessee
United States	Lenox Hill Hospital	New York	New York
United States	New York University School of Medicine/NYU Gastroenterology Associates	New York	New York
United States	Gastroenterology Associates of Orangeburg	Orangeburg	South Carolina
United States	Center for Interventional Endoscopy - AdventHealth Orlando	Orlando	Florida
United States	Gulf Region Clinical Research Institute	Pensacola	Florida
United States	Advanced Medical Research Center	Port Orange	Florida
United States	Premier Medical Group of the Hudson Valley	Poughkeepsie	New York
United States	Carolina's GI Research, LLC	Raleigh	North Carolina
United States	Inland Empire Clinical Trials, LLC	Rialto	California
United States	McGuire DVAMC, GI (111N)	Richmond	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Clinical Associates in Research Therapeutics of America, LLC	San Antonio	Texas
United States	Gastroenterology Research of San Antonio	San Antonio	Texas
United States	Pinnacle Clinical Research	San Antonio	Texas
United States	Kaiser Permanente	San Francisco	California
United States	TDDC San Marcos	San Marcos	Texas
United States	Clearview Medical Research, LLC	Santa Clarita	California
United States	Louisiana Research Center, LLC	Shreveport	Louisiana
United States	Texas Digestive Disease Consultants (IP Shipment)	Southlake	Texas
United States	Arizona Digestive Health - Sun City	Sun City	Arizona
United States	Atlanta Gastroenterology Specialist, PC	Suwanee	Georgia
United States	Tampa General Hospital	Tampa	Florida
United States	Spring Gastroenterology	The Woodlands	Texas
United States	Options Health Research LLC	Tulsa	Oklahoma
United States	Tyler Research Institute, LLC	Tyler	Texas
United States	Medstar Georgetown University Hospital (Patient Exams)	Washington	District of Columbia
United States	Shafran Gastroenterology Center	Winter Park	Florida
United States	Florida Medical Clinic, P.A.	Zephyrhills	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Galapagos NV	Gilead Sciences

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Croatia,  Czechia,  France,  Georgia,  Germany,  Greece,  Hong Kong,  Hungary,  Iceland,  India,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Singapore,  Slovakia,  South Africa,  Spain,  Sri Lanka,  Sweden,  Switzerland,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Induction Study: Percentage of Participants Who Achieved Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10	The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.; Clinical remission was defined as a CDAI of < 150 points.	Week 10
Primary	Induction Study: Percentage of Participants Who Achieved Endoscopic Response at Week 10	The Simple Endoscopic Score for Crohn's Disease (SES-CD) assessed the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater severity of disease. Endoscopic response was defined as = 50% reduction from baseline in total SES-CD score.	Week 10
Primary	Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by CDAI at Week 58	The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.; Clinical remission was defined as a CDAI of < 150 points.	Week 58
Primary	Maintenance Study: Percentage of Participants Who Achieved Endoscopic Response at Week 58	The SES-CD assessed the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater severity of disease. Endoscopic response was defined as = 50% reduction from baseline in total SES-CD score.	Week 58
Secondary	Induction Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 10	The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. Clinical Remission was defined as the average daily stool score =3 points AND average daily abdominal pain score =1 point.	Week 10
Secondary	Induction Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 10	The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.; Clinical response was defined as reduction in CDAI score from Induction baseline by at least 100 points or CDAI score < 150 points.	Week 10
Secondary	Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 58	The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. Clinical Remission was defined as the average daily stool score =3 points AND average daily abdominal pain score =1 point.	Week 58
Secondary	Maintenance Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 58	The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.; Clinical response was defined as reduction in CDAI score from Induction baseline by at least 100 points or CDAI score < 150 points.	Week 58
Secondary	Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by CDAI at Both Weeks 10 and 58	The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.; Sustained Clinical Remission by CDAI: CDAI <150 combined at both Week 10 and Week 58.	Weeks 10 and 58
Secondary	Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by CDAI at Week 58	The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.; 6-Month Corticosteroid-Free Clinical remission by CDAI: CDAI <150 with no corticosteroid use for indication of Crohn's disease for at least 6 months prior to Week 58.	Week 58
Secondary	Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by PRO2 at Both Weeks 10 and 58	The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days.; Sustained Clinical Remission by PRO2: liquid or very soft stool =3 and abdominal pain =1 combined at both Week 10 and Week 58.	Weeks 10 and 58
Secondary	Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by PRO2 at Week 58	The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days.; 6-month Corticosteroid-Free Clinical Remission by PRO2: liquid or very soft stool =3 and abdominal pain =1 with no corticosteroid use for at least 6 months prior to Week 58.	Week 58
Secondary	Induction Study:Pharmacokinetic Plasma Concentrations of Filgotinib at Week 4	Plasma concentrations of filgotinib [nanogram/milliliters (ng/mL)].	Week 4: 0.5, 1, 2, and 3 hours (hrs) post dose
Secondary	Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 10	Plasma concentrations of filgotinib (ng/mL).	Week 10: Predose
Secondary	Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 26	Plasma concentrations of filgotinib (ng/mL).	Week 26: At any timepoint
Secondary	Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 58	Plasma concentrations of filgotinib (ng/mL).	Week 58: Pre-dose
Secondary	Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 4	Plasma concentrations of GS-829845 (ng/mL).	Week 4: 0.5, 1, 2, and 3 hrs post dose
Secondary	Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 10	Plasma concentrations of GS-829845 (ng/mL).	Week 10: Predose
Secondary	Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 26	Plasma concentrations of GS-829845 (ng/mL).	Week 26: At any timepoint
Secondary	Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 58	Plasma concentrations of GS-829845 (ng/mL).	Week 58: Pre-dose