Crohn's Disease Clinical Trial
— DIVERSITY1Official 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
| Verified date | November 2023 |
| Source | Galapagos NV |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| 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. |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Galapagos NV | Gilead Sciences |
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,
| 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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