Study Stopped
development program for filgotinib for participants with Crohn's disease has been stopped
Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease
DIVERSITY LTE
A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Crohn's Disease
2 other identifiers
interventional
1,188
38 countries
481
Brief Summary
The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in Crohn's disease (CD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2017
Longer than P75 for phase_3
481 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2016
CompletedFirst Posted
Study publicly available on registry
September 26, 2016
CompletedStudy Start
First participant enrolled
March 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedResults Posted
Study results publicly available
July 10, 2024
CompletedJuly 10, 2024
May 1, 2024
6.4 years
September 22, 2016
May 29, 2024
July 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An AE was defined as any untoward medical occurrence in a participant administered a study drug, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug whether or not considered related to the study drug. Treatment-emergent adverse events (TEAEs) were defined as 1 or both of the following: * Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug * Any AEs leading to premature discontinuation of study drug.
From the First Dose to Week 312
Secondary Outcomes (3)
Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools
Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300
Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain
Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300
Change From Baseline in CDAI Scores
Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300
Study Arms (3)
Filgotinib 200 mg
EXPERIMENTALParticipants who received filgotinib 200 milligrams (mg) blinded and completed the parent study, continued to receive filgotinib 200 mg blinded in this study. After unblinding of the parent study, participants continued open-label on filgotinib 200 mg. Participants who exited the parent study due to disease worsening or failure to meet response or remission criteria, with the exception of US and Korean males who were not considered dual-biologic refractory, received filgotinib 200 mg open-label in this study. Treatment was administered orally once a day until filgotinib becomes commercially available or until the early termination (up to 308 weeks).
Filgotinib 100 mg
EXPERIMENTALParticipants who received filgotinib 100 mg blinded and completed the parent study, continued to receive filgotinib 100 mg blinded in this study. After unblinding of the parent study, participants continued open-label on filgotinib 100 mg. Male participants from the US \& Korea who were not considered dual biologic refractory, and who exited the parent study due to disease worsening or failure to meet response or remission criteria, received filgotinib 100 mg open-label in this study. Treatment was administered orally once a day until filgotinib becomes commercially available or until the early termination (up to 308 weeks).
Placebo
PLACEBO COMPARATORParticipants who received placebo and completed the parent study, continued to receive placebo in this extension study. After unblinding of the parent study, participants on placebo treatment discontinued study drug and study participation. Treatment was administered orally once a day until unblinding of the parent study (up to 308 weeks).
Interventions
Tablet administered orally once a day
Eligibility Criteria
You may qualify if:
- Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial
- Must have enrolled in a CD parent protocol, GS-US-419-4015, GS-US-419-4016 or GS-US-419-3895 or any other Gilead/Galapagos sponsored filgotinib treatment study for CD
- Females of childbearing potential must have a negative pregnancy test at Day 1 and must agree to continued monthly pregnancy testing during use of filgotinib treatment
- Female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception for the duration described in the protocol
- Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug
- Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study for CD
You may not qualify if:
- Known hypersensitivity to the study drug
- Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator or sponsor, would make the individual unsuitable for the study or would prevent compliance with the study protocol
- Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in the protocol
- Use of prohibited concomitant medications as outlined in the study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galapagos NVlead
- Gilead Sciencescollaborator
Study Sites (486)
Digestive Health Specialists Of The Southeast
Dothan, Alabama, 36305, United States
Arizona Digestive Health - Sun City
Sun City, Arizona, 85351, United States
Southern California Research Center, Inc.
Coronado, California, 92118, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Inland Empire Clinical Trials, LLC
Rialto, California, 92377, United States
UC San Diego Health Systems
San Diego, California, 92093, United States
Kaiser Permanente
San Francisco, California, 94118, United States
Clearview Medical Research, LLC
Santa Clarita, California, 91351, United States
University of Colorado Denver and Hospital
Aurora, Colorado, 80045, United States
South Denver Gastroenterology, PC
Lone Tree, Colorado, 80124, United States
Connecticut GI, PC - Research Division
Farmington, Connecticut, 06032, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Advanced Research, LLC
Coral Springs, Florida, 33067, United States
UF Clinical Research Center
Gainesville, Florida, 32610, United States
Florida Research Institute
Lakewood Rch, Florida, 34211, United States
Florida Center for Gastroenterology
Largo, Florida, 33777, United States
University of Miami Crohn's and Colitis Center
Miami, Florida, 33136, United States
Advanced Pharma CR, LLC
Miami, Florida, 33147, United States
Cordova Research Institute
Miami, Florida, 33155, United States
Vista Health Research, LLC
Miami, Florida, 33176, United States
Gastroenterology Group of Naples
Naples, Florida, 34102, United States
Center for Interventional Endoscopy - Florida Hospital
Orlando, Florida, 32803, United States
Gulf Region Clinical Research Institute
Pensacola, Florida, 32514, United States
Advanced Medical Research Center
Port Orange, Florida, 32127, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Florida Medical Clinic, P.A
Zephyrhills, Florida, 33540, United States
Gastroenterology Associates Of Central Georgia, LLC
Macon, Georgia, 31201, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, 30060, United States
Atlanta Gastroenterology Specialist, PC
Suwanee, Georgia, 30024, United States
Illinois Gastroenterology Group - Arlington Heights
Arlington Heights, Illinois, 60005, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611, United States
The University of Chicago Medical Center (Clinic)
Chicago, Illinois, 60637, United States
Illinois Gastroenterology Group - Gurnee
Gurnee, Illinois, 60031, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Louisville, Clinical Trials Unit
Louisville, Kentucky, 40202, United States
Delta Research Partners, LLC
Monroe, Louisiana, 71201, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105, United States
Investigative Clinical Research
Annapolis, Maryland, 21401, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Gastro Center of Maryland
Columbia, Maryland, 21045, United States
Meritus Center for Clinical Research
Hagerstown, Maryland, 21742, United States
Massachusetts General Hospital - Crohn's and Colitis Center
Boston, Massachusetts, 02114, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047, United States
Spectrum Health Butterworth Hospital
Grand Rapids, Michigan, 49546, United States
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
Wyoming, Michigan, 49519, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Kansas City Research Institute
Kansas City, Missouri, 64131, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Las Vegas Medical Research
Las Vegas, Nevada, 89113, United States
AGA Clinical Research Associates, LLC
Egg Harbor, New Jersey, 08234, United States
NY Scientific
Brooklyn, New York, 11235, United States
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, 11021, United States
New York University School of Medicine / NYU Gastroenterology Associates
New York, New York, 10016, United States
Lenox Hill Hospital
New York, New York, 10028, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, 12601, United States
Charlotte Gastroenterology & Hepatology, PLLC
Charlotte, North Carolina, 28207, United States
Carolina's GI Research LLC
Raleigh, North Carolina, 27607, United States
Fargo Gastroenterology and Hepatology Clinic
Fargo, North Dakota, 58103, United States
Consultants for Clinical Research
Cincinnati, Ohio, 45219, United States
UC Health Physicians Clifton
Cincinnati, Ohio, 45219, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060, United States
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, 44130, United States
Options Health Research LLC
Tulsa, Oklahoma, 74104, United States
Great Lakes Medical Research, LLC
Harrisburg, Pennsylvania, 17110, United States
Gastroenterology Associates of Orangeburg
Orangeburg, South Carolina, 29118, United States
WR-ClinSearch, LLC
Chattanooga, Tennessee, 37421, United States
Gastro One
Germantown, Tennessee, 38138, United States
Quality Medical Research
Nashville, Tennessee, 37211, United States
Vanderbilt University Medical Center - IBD Clinic
Nashville, Tennessee, 37212, United States
Texas Clinical Research Institute
Arlington, Texas, 76012, United States
Pinnacle Clinical Research
Austin, Texas, 78757, United States
Inquest Clinical Research
Baytown, Texas, 77521, United States
San Antonio Military Medical Center,
Fort Sam Houston, Texas, 78219, United States
DHAT Research Institute
Garland, Texas, 75044, United States
Kelsey-Seybold Clinic
Houston, Texas, 77025, United States
Baylor College of Medicine - McNair Campus
Houston, Texas, 77030, United States
The Methodist Hospital
Houston, Texas, 77030, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Centex Studies, Inc.
Houston, Texas, 77058, United States
Gulf Coast Research Group
Houston, Texas, 77098, United States
Clinical Associates in Research Therapeutics of America, LLC
San Antonio, Texas, 78212, United States
Gastroenterology Research of San Antonio
San Antonio, Texas, 78229, United States
Pinnacle Clinical Research
San Antonio, Texas, 78229, United States
TDDC San Marcos
San Marcos, Texas, 78666, United States
Texas Digestive Disease Consultants
Southlake, Texas, 76092, United States
Spring Gastroenterology
The Woodlands, Texas, 77380, United States
Tyler Research Institute, LLC
Tyler, Texas, 75701, United States
HP Clinical Research
Bountiful, Utah, 84010, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, 22911, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320, United States
McGuire DVAMC
Richmond, Virginia, 23249, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53705, United States
Wisconsin Center for Advanced Research, a division of GI Associates, LLC
Milwaukee, Wisconsin, 53215, United States
Fundacion Estudios Clinicos CiRec
Rosario, S2000DEF, Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010, Australia
Nepean Hospital
Kingswood, New South Wales, 2747, Australia
Wollongong Hospital
Wollongong, New South Wales, 2500, Australia
Coastal Digestive Health
Mountain Creek, Queensland, 4557, Australia
Coral Sea Clinical Research Institute (Mackay)
North Mackay, Queensland, 4740, Australia
Mater Misericordiae Ltd
South Brisbane, Queensland, 4101, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
Emeritus Research
Camberwell, Victoria, 3124, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Footscray Hospital
Footscray, Victoria, 3011, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
Cabrini Hospital
Malvern, Victoria, 3144, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Universitatsklinik Innsbruck
Innsbruck, 6020, Austria
Klinikum Klagenfurt am Wörthersee, Abt. Für Inn. Med. & Gastroenterol, (IMuG), Hepatol., Endokrinol., Rheumatol., & Nephrol.
Klagenfurt, 9020, Austria
AKH-Medizinische Universitat Wien
Vienna, 1090, Austria
GZA Ziekenhuizen, campus Sint-Vincentius
Antwerp, 2018, Belgium
Imelda General Hospital
Bonheiden, 2820, Belgium
CUB Hopital Erasme
Brussels, 1070, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Universitair Ziekenhuis Leuven
Leuven, 3000, Belgium
Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph
Liège, 4000, Belgium
CHR Citadelle
Liège, 4000, Belgium
AZ Delta
Roeselare, 8800, Belgium
Medical Center - Complete Medical Solutions OOD
Samokov, 2000, Bulgaria
Medical Center - "Tsaritsa Yoanna" EOOD
Sliven, 8800, Bulgaria
"MDHAT Dr. St.Cherkezov" AD
Veliko Tarnovo, 5000, Bulgaria
MHAT "Sveta Petka" AD
Vidin, 3700, Bulgaria
Barrie GI Associates
Barrie, L4M 7G1, Canada
University of Calgary, Heritage Medical Research Clinic
Calgary, T2N 4Z6, Canada
Hamilton Health Sciences Corporation, McMaster University Medical Centre
Hamilton, L8S 4K1, Canada
London Health Sciences Centre - University Hospital
London, N6A 5A5, Canada
TIDHI Innovation, Inc.
North York, M6A 3B4, Canada
ABP Research Services
Oakville, L6L 5L7, Canada
Royal University Hospital
Saskatoon, S7N 0W8, Canada
Mount Sinai Hospital
Toronto, M5T 3L9, Canada
The Gordon and Leslie Diamond Health Care Centre
Vancouver, V5Z 1M9, Canada
Toronto Digestive Disease Associates Inc.
Vaughan, L4L 4Y7, Canada
Percuro Clinical Research Ltd.
Victoria, V8V 3P9, Canada
University Hospital Center Osijek
Osijek, 31 000, Croatia
Clinical Hospital Dubrava
Zagreb, 10000, Croatia
University Hospital Center Zagreb
Zagreb, 10000, Croatia
Hepato-Gastroenterology HK, s.r.o.
Hradec Králové, 500 12, Czechia
Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni
Mladá Boleslav, 293 01, Czechia
G.E.P. Clinic, s r.o.
Prague, 130 00, Czechia
Thomayerova nemocnice, Interni klinika 3. LF UK a TN
Prague, 140 00, Czechia
ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zancty
Prague, 190 00, Czechia
CHU Amiens Picardie
Amiens, 80054, France
CHU de Caen
Caen, 14033, France
CHU de Clermont-Ferrand - Hopital d'Estaing
Clermont-Ferrand, 63003, France
APHP - Hopital Beaujon - Clichy - Universite Paris VII
Clichy, 92110, France
Centre Hospitalier Intercommunal de Creteil
Créteil, 94010, France
CHU de Dijon Bourgogne - Hopital Francois Mitterand
Dijon, 21079, France
CHU Grenoble Alpes
La Tronche, 38700, France
Hopital Universitaire de Bicetre
Le Kremlin-Bicêtre, 94270, France
Centre Hospitalier Regional Universitaire de Lille
Lille, 59000, France
Hopital Nord
Marseille, 13015, France
Hopital Saint Joseph
Marseille, 13285, France
CHU de Montpellier-Hopital Saint Eloi
Montpellier, 34295, France
CHU Hotel-Dieu
Nantes, 44093, France
Hopital de l'Archet 2
Nice, 06202, France
CHU de Bordeaux - Hopital Haut Leveque
Pessac, 33600, France
Centre Hospitalier Universitaire de Lyon Sud
Pierre-Bénite, 69495, France
CH Annecy Genevois - Site d'Annecy
Pringy, 74374, France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes, 35033, France
CHU de Saint Etienne - Hopital Nord
Saint-Priest-en-Jarez, 42055, France
Nouvel Hopital Civil
Strasbourg, 67091, France
Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre
Strasbourg, 67098, France
CHU de Toulouse - Hopital Rangueil
Toulouse, 31059, France
CHU de Nancy - Hopital Brabois Adultes
Vandœuvre-lès-Nancy, 54511, France
Unimed Ajara LLC - Batumi Referral Hospital
Batumi, 6010, Georgia
Medi Club Georgia LLC
Tbilisi, 0160, Georgia
Ltd. Unimed Kakheti - Telavi Referral Hospital
Telavi, 2200, Georgia
Charite Universitaetsmedizin Berlin
Berlin, 10117, Germany
Medizinisches Versorgungszentrum Delitzsch
Berlin, 10825, Germany
Charite - Universitatsmedizin Berlin
Berlin, 13353, Germany
DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin
Berlin, 14050, Germany
Stadtisches Klinikum Braunschweig gGmbH
Braunschweig, 38126, Germany
Universitaetsklinik Koln
Cologne, 50937, Germany
Universitatsklinikum Dresden
Dresden, 01307, Germany
Agaplesion Markus Krankenhaus
Frankfurt am Main, 60431, Germany
CED Studien UG, Interdisciplinary Crohn Colitis Center (iCCC)
Frankfurt am Main, 60594, Germany
Universitatsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Asklepios Westklinikum Hamburg
Hamburg, 22559, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Universitatsklinikum Heidelberg
Heidelberg, 69120, Germany
Praxis fur Gastroenterologie
Heidelberg, 69121, Germany
Gastroenterologische Gemeinschaftspraxis Herne
Herne, 44623, Germany
Universitatsklinikum Jena
Jena, 07747, Germany
Universitatsklinikum Schleswig-Holstein
Kiel, 24105, Germany
EUGASTRO GmbH
Leipzig, 04103, Germany
Universitatsklinikum Leipzig
Leipzig, 04103, Germany
Klinikum Luneburg
Lüneburg, 21339, Germany
Gastroenterologische Gemeinschaftspraxis Minden
Minden, 32423, Germany
Klinikum der Universitat Munchen - Grosshadern
München, 81377, Germany
Universitaetsmedizin Rostock, Zentrum fuer Innere Medizin
Rostock, 18057, Germany
Universitaetsklinikum Tuebingen
Tübingen, 72074, Germany
Universitatsklinikum Ulm, Zentrum Fur Innere Medizin
Ulm, 89081, Germany
Hippokration Hospital of Athens
Athens, 11527, Greece
University General Hospital "Attikon", 2nd Propaedeutic Internal Medicine Dept. and Research Unit, Hepatogastroenterology Unit
Athens, 12462, Greece
University General Hospital of Ioannina, Gastroenterology Department, Internal Medicine Division
Ioannina, 45332, Greece
University General Hospital of Patras "Panagia I Voithia", Gastroenterology Department, Internal Medicine Division
Pátrai, 26504, Greece
Hippokratio General Hospital of Thessaloniki "Hippokratio" 4th Internal Medicine Department of Aristotle University of Thessaloniki
Thessaloniki, 54642, Greece
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
Tuenmen, Hong Kong
Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia
Békéscsaba, 5600, Hungary
Szent Margit Korhaz, Gasztroenterológiai Osztály
Budapest, 1032, Hungary
Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.
Budapest, 1033, Hungary
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo
Budapest, 1097, Hungary
Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly
Budapest, 1125, Hungary
Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia
Debrecen, 4032, Hungary
Bugat Pal Korhaz, Belgyogyaszat
Gyöngyös, 3200, Hungary
Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia
Mosonmagyaróvár, 9200, Hungary
Landspitali University Hospital
Reykjavik, 101, Iceland
Lakeshore Hospital and Research Centre Ltd
Kochi, Kerala, 682040, India
Kaizen Hospital
Ahmedabad, 380052, India
Victoria Hospital, Bangalore Medical College and Research Institute (BMCRI)
Bangalore, 560002, India
M S Ramaiah Medical College and Hospital
Bangalore, 560054, India
Apollo Speciality Hospital
Chennai, 600035, India
VGM Hospital Institute of Gastroenterology
Coimbatore, 641005, India
Lourdes Hospital
Ernākulam, 682012, India
Fortis Memorial Research Institute
Gūrgaon, 122002, India
Gleneagles Global Hospital
Hyderabad, 500004, India
Citizens Specialty Hospital
Hyderabad, 500019, India
Centre for Liver Research & Diagnostics
Hyderabad, 500058, India
SR Kalla Memorial Gastro and General Hospital
Jaipur, 302001, India
S.M.S Hospital
Jaipur, 302004, India
School of Digestive & Liver Diseases
Kolkata, 700020, India
King George's Medical University
Lucknow, 226003, India
Dayanand Medical College & Hospital
Ludhiana, 141001, India
Kasturba Medical College (KMC) Hospital
Mangaluru, 575001, India
Seth G.S. Medical College & KEM Hospital
Mumbai, 400012, India
S.L. Raheja Hospital (A Fortis Associate)
Mumbai, 400016, India
Lokmanya Tilak Municipal General Hospital
Mumbai, 400022, India
Midas Multispeciality Hospital Pvt. Ltd
Nagpur, 440010, India
Suretech Hospital & Research Centre Ltd
Nagpur, 440012, India
All India Institute of Medical Sciences
New Delhi, 110029, India
Department of Surgery, B.J. Government Medical College & Sassoon General Hospital
Pune, 411001, India
Grant Medical Foundation Ruby Hall Clinic
Pune, 411001, India
Universal Hospital
Pune, 411011, India
Shree Giriraj Multispeciality Hospital
Rajkot, 360002, India
Gandhi Hospital
Secunderabad, 500003, India
Institute of Gastroenterology & Liver Disease. Sunshine Hospitals
Secunderabad, 500003, India
Surat Institute of Digestive Sciences
Surat, 395002, India
Kasturba Hospital Medical College
Udupi, 576104, India
Sterling Hospital
Vadodara, 390007, India
Samvedna Hospital
Varanasi, 221005, India
St. Vincent's University Hospital
Dublin, 4, Ireland
Beaumont Hospital
Dublin, 9, Ireland
Wellcome Trust HRB Clinical Research Facility
Dublin, DUBLIN 8, Ireland
University Hospital Galway
Galway, H91 YR71, Ireland
Emek Medical Center
Afula, 18101, Israel
Soroka Medical Center
Beersheba, 8410101, Israel
Bnai Zion Medical Center
Haifa, 31048, Israel
Rambam Medical Health Care Campus
Haifa, 3109601, Israel
The Edith Wolfson Medical Center
Holon, 5822012, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Hadassah Medical Center
Jerusalem, 9112001, Israel
Meir MC
Kefar Sava, 4428164, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
The Chaim Sheba Medical Center
Ramat Gan, 5265601, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
UOC Gastroenterologia II
Castellana Grotte, 70013, Italy
U.O. Fisiopatologia Digestiva
Catanzaro, 88100, Italy
UOC Medicina Interna
Cento, 44042, Italy
Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina
Chieti, 66100, Italy
Gastroenterologia clinica - Azienda Ospedaliero-Universitaria Careggi
Florence, 50134, Italy
Endocsopia Digestiva Centralizzata
Milan, 20121, Italy
UO Gastroenterologia
Modena, 40124, Italy
UOC Gastroenterologia
Padua, 35128, Italy
Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello
Pisa, 56124, Italy
UOC Gastroenterologia ed Endoscopia Digestiva
Roma, 00128, Italy
UOC di Gastroenterologia ed Endoscopia Digestiva
Roma, 00133, Italy
UOC Medicina Interna a Gastroenterologia
Roma, 00168, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
A.S.O. Ordine Mauriziano Di Torino S.C.
Torino, 10122, Italy
Ohmori Toshihide gastro-intestinal Clinic
Ageo-shi, 362-0075, Japan
Tokyo Medical and Dental University Hospital
Bunkyō City, 113-8519, Japan
Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital
Chūōku, 060-0033, Japan
Japanese Red Cross Fukuoka Hospital
Fukuoka, 815-8555, Japan
Tokai University Hachioji Hospital
Hachiōji, 192-0032, Japan
Hiroshima Prefectural Hospital
Hiroshima, 734-8530, Japan
Fukuoka University Hospital
Jonan-ku, 814-0180, Japan
Saitama Medical Center, Saitama Medical University
Kawagoe, 350-8550, Japan
Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center
Kitakyushu-shi, 802-0077, Japan
Yamanashi Prefectural Central Hospital
Kofu, 400-8506, Japan
Kurume University Hospital
Kurume-shi, 830-0011, Japan
Hidaka Coloproctology Clinic
Kurume-shi, 839-0809, Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, 602-8566, Japan
The Jikei University Hospital
Minatoku, 105-8471, Japan
Kitasato University Kitasato Institute Hospital
Minatoku, 108-8642, Japan
Kyorin University Hospital
Mitaka-shi, 181-8611, Japan
Iwate Medical University Hospital
Morioka, 020-8505, Japan
Aichi Medical University Hospital
Nagakute-shi, 480-1195, Japan
Nagasaki University Hospital
Nagasaki, 8528501, Japan
Nagoya City University Hospital
Nagoya, 467-8602, Japan
Saiseikai Niigata Daini Hospital
Nishiku, 950-1104, Japan
Hyogo College of Medicine College Hospital
Nishinomiya, 663-8501, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Kinshukai Infusion Clinic
Osaka, 530-0011, Japan
Osaka City University Hospital
Osaka, 545-8586, Japan
Wakakusa-Daiichi Hospital
Osaka, 579-8056, Japan
Ishida IBD Clinic
Ōita, 870-0823, Japan
Shiga University of Medical Science Hospital
Ōtsu, 520-2192, Japan
Saga-Ken Medical Centre Koseikan
Saga, 840-8571, Japan
Saga University Hospital
Saga, 849-8501, Japan
Tokito Clinic
Saitama, 336-0963, Japan
Toho University Sakura Medical Center
Sakura, 285-8741, Japan
Sapporo Higashi Tokushukai Hospital
Sapporo, 065-0033, Japan
National Hospital Organization Sendai Medical Center
Sendai, 983-8520, Japan
Osaka University Hospital
Suita, 565-0871, Japan
Kagawa Prefectural Central Hospital
Takamatsu, 760-8557, Japan
National Hospital Organization Takasaki General Medical Center
Takasaki-shi, 3700829, Japan
Ieda Hospital
Toyota-shi, 470-1219, Japan
Wakayama Medical University Hospital
Wakayama, 641-8509, Japan
Yokohama Health Medicine Association Kannai Suzuki Clinic
Yokohama, 231-0012, Japan
Universiti Kebangsaan Malaysia Medical Center
Cheras, 56000, Malaysia
Hospital Pulau Pinang
George Town, 10990, Malaysia
Hospital Queen Elizabeth
Kota Kinabalu, 88586, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, 25100, Malaysia
NZW Alkmaar (Noordwest Ziekenhuisgroep)
Alkmaar, 1815 JD, Netherlands
VU Medisch Centrum
Amsterdam, 1081 HV, Netherlands
Academic Medical Center (AMC)
Amsterdam, 1105 AZ, Netherlands
Gelre Hospital
Apeldoorn, 7334, Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9700 RB, Netherlands
Maastricht University Medical Centre
Maastricht, 6229 HX, Netherlands
Erasmus University Medical Center
Rotterdam, 3015 CE, Netherlands
Elisabeth-TweeSteden Hospital
Tilburg, 5022, Netherlands
University Medical Center Utrecht
Utrecht, 3584 CX, Netherlands
Christchurch Hospital
Christchurch, 8011, New Zealand
Southern District Health Board - Dunedin Hospital
Dunedin, 9016, New Zealand
Auckland City Hospital
Grafton, 1023, New Zealand
Waikato Hospital
Hamilton, 3240, New Zealand
Wellington Hospital
Newtown, 6021, New Zealand
Bay of Plenty District Health Board - Tauranga Hospital
Tauranga, 3112, New Zealand
Hutt Valley District Health Board - Hutt Valley Hospital
Wellington, 5010, New Zealand
Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych
Bialystok, 15-276, Poland
VITAMED Galaj i Cichomski spólka jawna
Bydgoszcz, 85-079, Poland
Szpital Uniwersytecki nr 2 im. Dr. Jana Biziela w Bydgoszczy, Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych
Bydgoszcz, 85-168, Poland
Gabinet Lekarski Janusz Rudzinski
Bydgoszcz, 85-681, Poland
NZOZ INTER-MED, Centrum Endoskopowe
Częstochowa, 42-217, Poland
Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS
Katowice, 40-659, Poland
Gabinet Endoskopii Przewodu Pokarmowego
Krakow, 31-009, Poland
Krakowskie Centrum Medyczne Sp. z o.o
Krakow, 31-501, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwerstyeckiego Szpitala Klinicznego nr 1 im. Norberta Barlickiego
Lodz, 90-153, Poland
Trialmed Crs
Piotrkow Trybunalski, 97-300, Poland
Clinical Research Center Sp. z o.o. Medic-R Sp.k.
Poznan, 60-848, Poland
Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski
Rzeszów, 35-301, Poland
Endoskopia Sp. z o.o.
Sopot, 81-756, Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, 71-434, Poland
GASTROMED Kopon, Zmudzkinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii
Torun, 87-100, Poland
H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K.
Tychy, 43-100, Poland
Centrum Zdrowia MDM
Warsaw, 00-635, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 00-728, Poland
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie
Warsaw, 02-507, Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
Warsaw, 02-781, Poland
Medical Concierge Centrum Medyczne
Warsaw, 02-798, Poland
Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz
Warsaw, 03-580, Poland
Bodyclinic
Warsaw, 03-712, Poland
Centrum Medyczne Oporow
Wroclaw, 52-416, Poland
Hospital de Braga
Braga, 4710-243, Portugal
Centro Hospitalar e Universitario de Coimbra, E.P.E.
Coimbra, 3000-075, Portugal
Centro Hospitalar Cova de Beira, EPE
Covilha, 6200-251, Portugal
Centro Hospitalar do Algarve EPE
Faro, 8000-386, Portugal
Hospital da Senhora da Oliveira Guimaraes, E.P.E.
Guimarães, 4835-044, Portugal
Hospital Beatriz Angelo
Loures, 2674-514, Portugal
Centro Hospitalar de Sao Joao, EPE
Porto, 4200-319, Portugal
Unidade Local de Saúde do Alto Minho
Viana do Castelo, 4904-858, Portugal
MedLife, Gastroenterologie
Bucharest, 010719, Romania
Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila - Sectia Clinica de Gastroenterologie
Bucharest, 010825, Romania
S.C. Centrul Medical Sana S.R.L., Gastroenterologie
Bucharest, 011025, Romania
Delta Health Care/ Ponderas Academic Hospital
Bucharest, 014142, Romania
Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie
Bucharest, 020125, Romania
MedLife, Gastroenterologie
Bucharest, 031784, Romania
Spitalul Universitar de Urgenta Bucuresti - Sectia Medicina Interna II
Bucharest, 050098, Romania
Gastromedica SRL, Gastroenterologie
Iași, 700506, Romania
Cabinet Particular Policlinic Algomed SRL
Timișoara, 300002, Romania
Centrul Medical Tuculanu, Gastroenterologie
Timișoara, 300168, Romania
S.C. Policlinica Dr. Citu S.R.L.- Gastroenterologie
Timișoara, 300594, Romania
State Budgetary Healthcare Institution "Chelyabinski Regional Clinical Hospital"
Chelyabinsk, 454076, Russia
State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital
Irkutsk, 669079, Russia
State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy"
Moscow, 129110, Russia
State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A.
Nizhny Novgorod, 603126, Russia
State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"
Novosibirsk, 630087, Russia
State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12"
Novosibirsk, 630091, Russia
Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38"
Saint Petersburg, 191015, Russia
"Scientific Research Centre ECO-safety" LLC
Saint Petersburg, 196143, Russia
"PolyClinic EXPERT" LLC
Saint Petersburg, 197110, Russia
State Healthcare Institution "Regional Clinical Hospital"
Saratov, 410053, Russia
Clinical Hospital Center Zemun
Belgrade, 11000, Serbia
University Hospital Medical Center Bezanijska kosa
Belgrade, 3010-777, Serbia
Clinical Center of Serbia
Belgrade, 3618-445, Serbia
Zvezdara University Medical Center
Belgrade, 3810-970, Serbia
Clinical Center of Vojvodina
Novi Sad, 21000, Serbia
National University Hospital
Singapore, 119074, Singapore
Singapore General Hospital
Singapore, 169608, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Changi General Hospital
Singapore, 529889, Singapore
Cliniq s. r. o., Gastroenterologicke centrum Ruzinov
Bratislava, 82007, Slovakia
KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
Nitra, 950 01, Slovakia
Gastro I., s.r.o.
Prešov, 8001, Slovakia
Dr MJ Prins
Cape Town, 7500, South Africa
Dr John P Wright
Cape Town, 7708, South Africa
Peermed Clinical Trial Centre
Johannesburg, 1619, South Africa
Pusan National University Hospital
Busan, 49241, South Korea
Yeungnam University Hospital
Daegu, 42415, South Korea
Kyung Hee University Hospital
Guri-si, 471-701, South Korea
Hanyang University Guri Hospital
Gyeonggi-do, 11923, South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, 463-712, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Yonsei University Health System, Severance Hospital
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Division of Gastroenterology, Department of Medicine, Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, 16247, South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, 220-701, South Korea
Hospital Universitari Germans Trias i Pujol
Badalona, 08916, Spain
Centro Medico Teknon
Barcelona, 08022, Spain
Hospital del Mar
Barcelona, 8003, Spain
Complejo Hospitalario Universitario de Ferrol
Ferrol, 15405, Spain
Hospital Universitario de Gran Canaria "Dr. Negrin"
Las Palmas de Gran Canaria, 35010, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario de Fuenlabrada
Madrid, 28942, Spain
Hospital Universitario Central de Asturias
Oviedo, 33006, Spain
Hospital de Montecelo
Pontevedra, 36071, Spain
Hospital de Sagunto
Sagunto, 46520, Spain
Hospital Universitario Virgen del Rocío
Seville, 41013, Spain
Hospital de Galdakao-Usandolo
Usansolo, 48960, Spain
National Hospital of Sri Lanka
Colombo, 00700, Sri Lanka
Karapitiya Teaching Hospital
Galle, 80000, Sri Lanka
Kandy Teaching Hospital
Kandy, 20000, Sri Lanka
Colombo North Teaching Hospital
Ragama, 11010, Sri Lanka
Danderyds Sjukhus AB
Danderyd, SE-18288, Sweden
Akademiska Sjukhuset
Uppsala, 75185, Sweden
Intesto Gastroenterologische Praxis & Crohn-Colitis-Zentrum Bern
Bern, 3012, Switzerland
Universitätsspital Zürich
Zurich, 8091, Switzerland
Changhua Christian Hospital
Changhua, 500, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Far Eastern Memorial Hospital
New Taipei City, 220, Taiwan
Chang Shan Medical University Hospital
Taichung, 40201, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
National Cheng Kung University Hospital
Tainan, 7428, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Mackay Memorial Hospital, Taipei
Taipei, 104, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Tri-Service General Hospital
Taipei, 114, Taiwan
Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch
Taoyuan District, 33305, Taiwan
Multispecialty Clinical Hospital of Intensive Treatments and Emergency Medical Care
Chernivtsi, 58000, Ukraine
Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", Surgical Department
Chernivtsi, 58000, Ukraine
State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"
Dnipropetrovsk, 49000, Ukraine
Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National
Ivano-Frankivsk, 76018, Ukraine
Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department
Kharkiv, 61037, Ukraine
Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1
Kharkiv, 63101, Ukraine
Treatment and Diagnostic Center of Private Enterprise of Private Production Company "Acinus"
Kropyvnytskyi, 25006, Ukraine
Kyiv City Clinical Hospital No. 18, Proctology Department
Kyiv, 01030, Ukraine
Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department
Kyiv, 1103, Ukraine
Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department
Odesa, 65025, Ukraine
Ternopil Regional Clinical Hospital, Regional Center of Gastroenterology with Hepatology
Ternopil, 46002, Ukraine
Municipal Institution "Uzhgorod District Hospital", Therapy Department
Uzhhorod, 88009, Ukraine
Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1
Vinnytsia, 21005, Ukraine
M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department
Vinnytsia, 21018, Ukraine
Medical Center LLC "Health Clinic"
Vinnytsia, 21029, Ukraine
Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council
Zaporizhzhya, 69600, Ukraine
Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich, Norfolk, NR4 7UY, United Kingdom
Queen Elizabeth Hospital
Birmingham, B15 2WB, United Kingdom
The Pennine Acute Hospitals NHS Trust
Bury, BL9 7TD, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB20QQ, United Kingdom
NHS Lothian
Edinburgh, EH4 2XU, United Kingdom
Royal Devon and Exeter NHS Foundation Trust
Exeter, EX2 5DW, United Kingdom
Glasgow Clinical Research Facility - Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, G52 3NQ, United Kingdom
Wycombe Hospital
High Wycombe, HP11 2TT, United Kingdom
St George's University Hospitals NHS Foundation Trust
London, SW17 0QT, United Kingdom
Imperial College Healthcare NHS Trust, St Mary's Hospital
London, W2 1NY, United Kingdom
Oxford University Hospitals NHS Trust
Oxford, OX3 9DU, United Kingdom
St Helens and Knowsley Teaching Hospitals NHS Trust
Prescot, L35 5DR, United Kingdom
Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility
Southampton, SO16 6YD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The results of DIVERSITY 1 study with filgotinib in participants with moderate to severely active CD failed to meet the co-primary endpoints of clinical remission and endoscopic response for filgotinib 100 mg q.d. and 200 mg q.d. in the study. After analyzing all available data from the DIVERSITY 1 and DIVERSITY long term extension (LTE) studies, the sponsor decided not to pursue extension of the filgotinib indication for CD and decided to terminate the DIVERSITY LTE study.
Results Point of Contact
- Title
- Galapagos Medical Information
- Organization
- Galapagos NV
Study Officials
- STUDY DIRECTOR
Galapagos Study Director
Galapagos NV
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Participants received blinded treatment during different phases in the study.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2016
First Posted
September 26, 2016
Study Start
March 17, 2017
Primary Completion
August 1, 2023
Study Completion
August 1, 2023
Last Updated
July 10, 2024
Results First Posted
July 10, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share