A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433
Crohn's Disease
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Upadacitinib, ABT-494, Extension Study, Efficacy, Safety, Crohn's Disease, Maintenance Study
Eligibility Criteria
Inclusion Criteria:
For Substudy 1:
- Participant who achieve clinical response in Study M14-431 or Study M14-433.
- Participant completes study procedures in the parent study. The final endoscopy for Studies M14-431 or M14-433 may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic.
For Substudy 2:
- Participant completes Substudy 1. The Week 52 endoscopy may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic.
- Participant who achieved clincal response at the time descibed in the protocol and completes study procedures in the parent study/ substudy.
Exclusion Criteria:
For Sub-studies 1 and 2:
- Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
- Participant who has a known hypersensitivity to upadacitinib or its excipients, or had an adverse event during Studies M14-431 and M14-433 or Substudy 1 of Study M14-430 that in the investigator's judgment makes the participant unsuitable for this study.
- Participant with any active or chronic recurring infections based on the investigator's assessment that makes the participant an unsuitable candidate for the study. Participants with serious infections undergoing treatment may be enrolled BUT NOT dosed until the infection treatment has been completed and the infection is resolved, based on the investigator's assessment.
- Participants with high grade colonic dysplasia or malignancy diagnosed at the endoscopy performed at the final visit of Studies M14-431, M14-433 or Substudy 1 of Study M14-430 (Week 52).
Sites / Locations
- East View Medical Research, LLC /ID# 171132
- CB Flock Research Corporation /ID# 166239
- Delsol Research Management, Ll /Id# 170164
- HonorHealth Research Institute - Shea /ID# 164725
- Arizona Arthritis & Rheumatology Research, PLLC /ID# 164702
- Southern California Res. Ctr. /ID# 169653
- Citrus Valley Gastroenterology /ID# 166230
- Hoag Memorial Hosp Presbyterian /ID# 222538
- UC San Diego Health System /ID# 164763
- United Medical Doctors /ID# 207458
- Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164640
- Facey Medical Foundation /ID# 203138
- United Medical Doctors - Murrieta /ID# 164602
- Medical Assoc Research Grp /ID# 169704
- UCSF Center for Colitis and Crohn's Disease /ID# 202372
- Univ of California San Francis /ID# 164653
- Care Access Research /ID# 167765
- Peak Gastroenterology Associates, PC /ID# 170166
- Delta Waves, Inc. /ID# 164656
- Western States Clinical Res /ID# 164625
- Medical Research Center of CT /ID# 164614
- Clinical Research of West Florida, Inc /ID# 205828
- Clinical Research of West Florida, Inc /ID# 208119
- Advanced Research - Coral Springs /ID# 218019
- Encore Borland-Groover Clinical Research /Id# 203500
- Ctr for Advanced Gastroenterol /ID# 165306
- Crystal Pharmacology Research /ID# 166118
- Coral Research Clinic /ID# 164604
- Advanced Research Institute, Inc /ID# 164601
- Endoscopic Research, Inc. /ID# 206139
- Omega Research Maitland, LLC /ID# 203482
- Clinical Research Trials of Florida, Inc. /ID# 203486
- AdventHealth Tampa /ID# 171181
- Gastroenterology Associates of Central Georgia, LLC /ID# 165492
- Gastroenterology Consultants PC - Roswell /ID# 218218
- Atlanta Gastroenterology Spec /ID# 164698
- Treasure Valley Medical Research /ID# 215030
- Rush University Medical Center /ID# 165470
- University of Chicago Medicine /ID# 165509
- DuPage Medical Group /ID# 205320
- MediSphere Medical Research Center /ID# 166233
- Indianapolis Gastroenterology /ID# 164649
- Aquiant Research /ID# 205505
- University of Iowa Hospitals and Clinics /ID# 165405
- Tri-State Gastroenterology /ID# 165469
- University of Louisville /ID# 165391
- University of Louisville /ID# 168520
- Houma Digestive Health Special /ID# 164727
- Nola Research Works, LLC /ID# 164612
- Louisana Research Center, LLC /ID# 164694
- Johns Hopkins University School of Medicine /ID# 211939
- MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 164647
- Gastro Center of Maryland /ID# 171180
- Lahey Hospital and Medical Center /ID# 214724
- University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 164654
- Clin Res Inst of Michigan, LLC /ID# 170163
- Digestive Health Associates (DHA) - Farmington Hills /ID# 206101
- Center for Digestive Health /ID# 164726
- Mayo Clinic - Rochester /ID# 164691
- Southern Therapy and Advanced Research (STAR) LLC /ID# 165295
- Quality Clinical Research Inc. /ID# 170162
- CHI Health Research Center /ID# 168513
- Las Vegas Medical Research /ID# 168551
- AGA Clinical Research Associates, LLC /ID# 164641
- Rutgers Robert Wood Johnson /ID# 166110
- Montefiore Medical Center - Moses Campus /ID# 166242
- Advantage Clinical Trials /ID# 168582
- NY Scientific /ID# 164630
- United Health Services Hospitals, Inc /ID# 217483
- NYU Langone Long Island Clinical Research Associates /ID# 164627
- The Mount Sinai Hospital /ID# 170256
- Columbia Univ Medical Center /ID# 164692
- Gastoenterology Group of Rochester /ID# 166235
- Richmond University Medical Center /ID# 201858
- Atrium Health Carolinas Medical Center /ID# 164632
- PMG Research of Charlotte /ID# 171178
- Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 164752
- Wake Forest Baptist Medical Center /ID# 164755
- Plains Clinical Research Center, LLC /ID# 170169
- Gastro Health Research /ID# 164668
- University of Cincinnati /ID# 164729
- Cleveland Clinic Main Campus /ID# 209230
- Ohio State University/ Gastroe /ID# 170159
- Optimed Research, Ltd. /ID# 205625
- Hometown Urgent Care and Resea /ID# 201289
- Dayton Gastroenterology, Inc. /ID# 167623
- Great Lakes Gastroenterology Research, LLC /ID# 202006
- Digestive Disease Specialists /ID# 201063
- Options Health Research, LLC /ID# 164704
- Healthcare Research Consultant /ID# 166244
- University of Pennsylvania /ID# 168406
- Thomas Jefferson University /ID# 168003
- Pharmacorp Clinical Trials /ID# 165008
- Gastroenterology Associates, P.A. of Greenville /ID# 164643
- Rapid City Medical Center - GI Research /ID# 201733
- Gastro One /ID# 164730
- East Tennessee Research Institute /ID# 203614
- Quality Medical Research /ID# 205264
- Vanderbilt University Medical Center /ID# 164607
- TX Clinical Research Institute /ID# 164719
- Inquest Clinical Research /ID# 164676
- Texas Digestive Disease Consultants /ID# 209954
- Texas Digestive Disease Consultants /ID# 209803
- Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 170161
- Baylor College of Medicine - Baylor Medical Center /ID# 164609
- Centex Studies, Inc. - Houston /ID# 201212
- GI Specialists of Houston /ID# 202340
- Caprock Gastro Research, LLC /ID# 215436
- Clinical Associates in Research Therapeutics of America, LLC /ID# 164675
- Southern Star Research Institute, LLC /ID# 169756
- Carl R. Meisner Medical Clinic /ID# 171057
- Tyler Research Institute, LLC /ID# 168679
- Gastro Health & Nutrition - Victoria /ID# 167810
- HP Clinical Research /ID# 164631
- Advanced Research Institute /ID# 164689
- Duplicate_Care Access Research /ID# 164685
- Velocity Clinical Research - Salt Lake City /ID# 166113
- Washington Gastroenterology /ID# 164728
- Virginia Mason Medical Center /ID# 164862
- University of Washington /ID# 164646
- The Vancouver Clinic, INC. PS /ID# 164874
- Froedtert Memorial Lutheran Hospital /ID# 202285
- Allegiance Research Specialists /ID# 165298
- Cardio Alem /ID# 211283
- Hospital Italiano de Buenos Aires /ID# 215542
- Gedyt /ID# 210018
- Cemic /Id# 169183
- Hospital Provincial del Centenario /ID# 171251
- Hospital Privado Univesitario /ID# 169229
- Concord Repatriation General Hospital /ID# 171506
- Coral Sea Clinical Research institute /ID# 212989
- Mater Misericordiae Limited /ID# 204910
- Royal Adelaide Hospital /ID# 171508
- Box Hill Hospital /ID# 203735
- Fiona Stanley Hospital /ID# 171507
- Klinik Landstrasse /ID# 203438
- Medizinische Universitaet Wien /ID# 169459
- Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 214468
- UCL Saint-Luc /ID# 200293
- CHU de Liege Sart Tilman /ID# 200294
- CHU UCL Namur - site Godinne /ID# 200295
- Universitair Ziekenhuis Leuven /ID# 200031
- AZ Sint-Lucas /ID# 200296
- University Clinical Centre of the Republic of Srpska /ID# 200743
- University Clinical Center Tuzla /ID# 210323
- Clinical Center University of Sarajevo /ID# 201346
- Polyclinic and Daily Hospital Dr. Al-Tawil /ID# 217843
- Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 166853
- Hospital Nossa Senhora das Graças /ID# 166856
- Hospital de Clinicas de Porto Alegre /ID# 166855
- Upeclin Fmb - Unesp /Id# 166860
- Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 166859
- Faculdade de Medicina do ABC /ID# 166854
- Kaiser Clinica e Hospital Dia /ID# 166858
- UMHAT Kaspela EOOD /ID# 167615
- Duplicate_Second MHAT Sofia /ID# 167616
- MHAT Trakia /ID# 201677
- University of Calgary /ID# 166990
- Allen Whey Khye Lim Professional Corporation /ID# 168047
- University of Alberta - Zeidler Ledcor Centre /ID# 166987
- Covenant Health /ID# 166996
- Fraser Clinical Trials Inc /ID# 166984
- GIRI Gastrointestinal Research Institute /ID# 166994
- QEII - Health Sciences Centre /ID# 169308
- London Health Sciences Center /ID# 221039
- Scott Shulman Medicine Professional Corporation /ID# 169065
- Taunton Surgical Centre /ID# 168045
- Ottawa Hospital Research Institute /ID# 212412
- Medicor Research Inc /ID# 166997
- Toronto Digestive Disease Asso /ID# 166988
- Hotel Dieu de Levis /ID# 166985
- Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 170122
- Royal Victoria Hospital / McGill University Health Centre /ID# 170011
- CIUSSS de l'Estrie - CHUS /ID# 170936
- Research Group /ID# 203178
- Hospital Guillermo Grant Benavente de Concepción /ID# 212421
- CTR Estudios Clinicos /ID# 203940
- Hospital Clinico Universidad De Los Andes /ID# 207463
- CEC SpA /ID# 169872
- Beijing Friendship Hospital /ID# 204175
- Zhongshan Hospital Xiamen University /ID# 204986
- The First Affiliated Hospital, Sun Yat-sen University /ID# 205227
- Nanfang Hospital of Southern Medical University /ID# 204056
- The Sixth Affiliated Hosp Sun /ID# 204054
- Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 204065
- Tongji Hospital Tongji Medical College of HUST /ID# 204051
- Nanjing Drum Tower Hospital /ID# 204899
- The First Affiliated Hospital of Nanchang University /ID# 204052
- The First Hospital of Jilin University /ID# 206865
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 204055
- The second Affiliated hospital of Zhejiang University school of Medicine /ID# 204058
- Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 204050
- The Second Xiangya Hospital of Central South University /ID# 204057
- Duplicate_Tianjin Med Univ General Hosp /ID# 206979
- Hospital San Vicente de Paul /ID# 200020
- Hospital Pablo Tobon Uribe /ID# 202403
- Clinical Hospital Dubrava /ID# 171165
- Klinicki bolnicki centar Sestre milosrdnice /ID# 171194
- Klinicki bolnicki centar Zagreb /ID# 171168
- Poliklinika Solmed /ID# 211517
- UHC Split /ID# 171205
- Zadar General Hospital /ID# 205533
- Nemocnice Ceske Budejovice a.s. /ID# 224390
- Hepato-Gastroenterologie HK, s.r.o. /ID# 171564
- ARTROSCAN s.r.o. /ID# 171575
- ResTrial s.r.o. /ID# 208651
- Herlev Hospital /ID# 200785
- Nordsjaellands Hospital /ID# 200788
- Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 200787
- Duplicate_Sjaellands Universitets Hospital /ID# 200786
- Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171008
- Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171017
- Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 209561
- National Hepatology and Tropical Medicine Research Institute /ID# 170991
- Faculty of Medicine Ain Shams Research Institute- Clinical Research Centre /ID# 209566
- Air Force Specialized Hospital /ID# 170993
- National Liver Institute /ID# 170987
- Tartu University Hospital /ID# 203141
- West Tallinn Central Hospital /ID# 202787
- Chu de Nice-Hopital L'Archet Ii /Id# 171004
- HCL - Hopital Lyon Sud /ID# 171030
- CHU Bordeaux - Hopital Haut Leveque /ID# 207812
- CHRU Lille - Hopital Claude Huriez /ID# 206653
- Duplicate_Hopital Saint Eloi /ID# 170039
- Hopital Beaujon /ID# 171007
- CHU de SAINT ETIENNE - Hopital Nord /ID# 171027
- CHRU Nancy - Hopitaux de Brabois /ID# 170970
- CH Valenciennes /ID# 222399
- CHU Amiens-Picardie Site Sud /ID# 171023
- CHRU Tours - Hopital Trousseau /ID# 169783
- Duplicate_CHU Henri Mondor /ID# 169782
- CHU Grenoble - Hopital Michallon /ID# 222403
- Clinique Jules Verne /ID# 222240
- Polyclinique Grand Sud /ID# 170037
- CHU Toulouse - Hopital Rangueil /ID# 169784
- Universitatsklinikum Mannheim /ID# 168754
- Universitaetsklinikum Ulm /ID# 203554
- Universitaetsklinikum Erlangen /ID# 203550
- Universitaetsklinikum Frankfurt /ID# 203567
- Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 206739
- Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 168755
- Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 169271
- Gastroenterologie am Mexikoplatz /ID# 203574
- Universitaetsmedizin Essen St. Josef Krankenhaus Werden /ID# 203569
- Agaplesion Markus Krankenhaus /ID# 168753
- Universitaetsklinikum Halle (Saale) /ID# 207453
- Medizinisches Versorgungszentrum Portal 10 /ID# 200212
- General Hospital of Athens Ippokratio /ID# 167032
- General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202102
- Tzaneio general hospital of Piraeus /ID# 206435
- University General Hospital of Heraklion PA.G.N.I /ID# 167031
- General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 167033
- General Hospital of Thessaloniki Hippokrateio /ID# 208823
- Queen Mary Hospital /ID# 171214
- Tuen Mun Hospital /ID# 171213
- Mohacsi Korhaz /ID# 209440
- CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 205549
- Debreceni Egyetem Klinikai Kozpont /ID# 216420
- Bugat Pal Korhaz /ID# 201885
- Szent Borbala Korhaz /ID# 209896
- Obudai Egeszsegugyi Centrum Kft. /ID# 201886
- Semmelweis Egyetem /ID# 210166
- Magyar Honvedseg Egeszsegugyi Kozpont /ID# 200888
- Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 200887
- Pest Megyei Flor Ferenc Korhaz /ID# 206153
- Mentahaz Maganorvosi Kozpont /ID# 201888
- Mercy University Hospital /ID# 206512
- Soroka University Medical Center /ID# 169911
- Tel Aviv Sourasky Medical Center /ID# 206450
- Hadassah Medical Center-Hebrew University /ID# 169926
- Barzilai Medical Center /ID# 223374
- Assaf Harofeh Medical Center /ID# 206449
- Rabin Medical Center /ID# 202634
- Kaplan Medical Center /ID# 170275
- University of Catanzaro /ID# 201986
- Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 168151
- Azienda Ospedaliera San Camillo Forlanini /ID# 168152
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 168150
- Istituto Clinico Humanitas /ID# 168153
- Fondazione PTV Policlinico Tor Vergata /ID# 168156
- IRCCS Ospedale Sacro Cuore Don Calabria /ID# 168154
- IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 168155
- A.O. Per L'Emergenza Cannizzaro /ID# 168161
- Policlinico San Martino/Univer /ID# 168162
- ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 168149
- ASST Grande Ospedale Metropolitano Niguarda /ID# 170906
- Azienda Ospedaliero-Universitaria di Modena /ID# 200009
- A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 168157
- Azienda Ospedaliero Universitaria Pisana-Stabilimento di Cisanello /ID# 202419
- Aichi Medical University Hospital /ID# 165989
- Nagoya City University Hospital /ID# 165988
- Nagoya University Hospital /ID# 165987
- Toyohashi Municipal Hospital /ID# 200176
- National Hospital Organization Hirosaki General Medical Center /ID# 165976
- Toho University Sakura Medical Center /ID# 165978
- Fukuoka University Chikushi Hospital /ID# 214402
- Kurume University Hospital /ID# 165996
- National Hospital Organization Takasaki General Medical Center /ID# 167151
- NHO Fukuyama Medical Center /ID# 167155
- Hiroshima University Hospital /ID# 165998
- Asahikawa Medical University Hospital /ID# 167148
- Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 165975
- Sapporo Medical University Hospital /ID# 167152
- Sapporo IBD Clinic /ID# 223559
- Aoyama Clinic /ID# 165993
- Hyogo Medical University Hospital /ID# 165991
- Kanazawa University Hospital /ID# 169212
- Iwate Medical University Uchimaru Medical Center /ID# 202465
- Imamura General Hospital /ID# 227135
- Idzuro Imamura Hospital /ID# 206655
- Sameshima Hospital /ID# 206677
- Yokohama City University Medical Center /ID# 167156
- Japanese Red Cross Kyoto Daiichi Hosital /ID# 165990
- Kyoto University Hospital /ID# 169887
- Yokkaichi Hazu Medical Center /ID# 167201
- Tohoku University Hospital /ID# 167150
- Nara Medical University Hospital /ID# 169213
- Kenseikai Dongo Hospital /ID# 208105
- Niigata University Medical & Dental Hospital /ID# 170042
- Ishida Clinic of IBD and Gastroenterology /ID# 167149
- Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 165994
- Okayama University Hospital /ID# 167354
- Kinshukai Infusion Clinic /ID# 218873
- Osaka Metropolitan University Hospital /ID# 165999
- Osaka University Hospital /ID# 169661
- Osaka Medical and Pharmaceutical University Hospital /ID# 206323
- Tokitokai Tokito clinic /ID# 165977
- Shiga University of Medical Science Hospital /ID# 167157
- Hamamatsu University Hospital /ID# 224402
- NHO Shizuoka Medical Center /ID# 167153
- Tokyo Medical And Dental University Hospital /ID# 165982
- Tokai University Hachioji Hospital /ID# 165984
- The Jikei University Hospital /ID# 167154
- Kyorin University Hospital /ID# 165983
- Tokyo Women's Medical University Hospital /ID# 205979
- Toyama Prefectural Central Hospital /ID# 217836
- Japanese Red Cross Wakayama Medical Center /ID# 200641
- Wakayama Medical University Hospital /ID# 169480
- Yamagata University Hospital /ID# 200158
- Hanyang University Gurihospital /ID# 167563
- CHA University Bundang Medical Center /ID# 167569
- Kangbuk Samsung Hospital /ID# 167562
- Yonsei University Health System Severance Hospital /ID# 167567
- Inje University Haeundae Hospital /ID# 202631
- Dong-A University Hospital /ID# 167568
- Pusan National University Hospital /ID# 167565
- Kyungpook National University Hospital /ID# 207020
- Samsung Medical Center /ID# 167564
- Chung-Ang University Hostipal /ID# 207021
- VCA Polyclinic Aura /ID# 169499
- Pauls Stradins Clinical University Hospital /ID# 169494
- Digestive Disease Center Gastro /ID# 169518
- Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 207030
- Vilnius University Hospital Santaros Klinikos /ID# 203269
- Hospital Sultanah Bahiyah /ID# 201317
- Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 170780
- Universiti Sains Malaysia /ID# 200101
- Instituto de Investigaciones Aplicadas a la Neurociencias A.C. /ID# 207681
- Morales Vargas Centro de Investigacion S.C. /ID# 203496
- Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 206843
- Radboud Universitair Medisch Centrum /ID# 166931
- Zuyderland Medisch Centrum /ID# 169699
- Onze Lieve Vrouwe Gasthuis /ID# 166932
- Academisch Medisch Centrum /ID# 166930
- Medisch Spectrum Twente /ID# 170299
- Vistamed /ID# 208571
- Malopolskie Centrum Kliniczne /ID# 202169
- WIP Warsaw IBD Point Profesor Kierkus /ID# 224302
- Centrum Zdrowia MDM /ID# 200493
- Centrum Medyczne Reuma Park /ID# 200489
- Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 170204
- Hospital Egas Moniz /ID# 170232
- Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 200608
- Hospital Garcia de Orta, EPE /ID# 170209
- Centro Hospitalar Universitario de Sao Joao, EPE /ID# 170211
- Mindful Medical Research /ID# 203356
- School of Medicine University of Puerto Rico-Medical Science Campus /ID# 166769
- Institutul Clinic Fundeni /ID# 167831
- Clinica GASTRO MED SRL /ID# 206363
- Cabinet Particular Policlinic Algomed /ID# 167832
- Immanuel Kant Baltic Federal University /ID# 203810
- LLC Medical Center /ID# 209234
- Perm Clinical Center of the Federal Medical and Biological Agency /ID# 202989
- LLC Novaya Klinika /ID# 206613
- Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 202996
- Kazan State Medical University /ID# 169589
- Olla-Med Clinic /ID# 208723
- P.A. Bayandin Murmansk Regiona /ID# 169590
- Republican hospital named after V.A. Baranov /ID# 206497
- Euromedservice /ID# 206608
- X7 Clinical Research Center /ID# 216348
- City Clinical Hospital No. 31 /ID# 208871
- Clinical Hosp Center Zvezdara /ID# 168216
- Military Medical Academy /ID# 168785
- University Clinical Center Serbia /ID# 168217
- Clin Hosp Ctr Bezanijska Kosa /ID# 168787
- University Clinical Center Kragujevac /ID# 205856
- Clinical Center Vojvodina /ID# 168196
- KL Ling Gastroenterology and Liver Clinic /ID# 205739
- Gleneagles Medical Centre /ID# 206019
- Tan Tock Seng Hospital /ID# 203158
- Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 169960
- KM Management, spol. s.r.o. /ID# 170202
- Univ Medical Ctr Ljubljana /ID# 211041
- Farmovs (Pty) Ltd /Id# 207534
- Lenasia Clinical Trial Centre /ID# 205143
- Wits Clinical Research Site /ID# 170850
- Allergy & Immunology (AIU) /ID# 171427
- Dr JP Wright /ID# 170882
- Private Practice Dr MN Rajabally /ID# 169851
- Hospital Unversitario Marques de Valdecilla /ID# 202495
- Hospital Universitari Son Espases /ID# 201969
- Hospital Universitario Dr. Negrin /ID# 202723
- Hospital Universitario de Navarra /ID# 202354
- Hospital Universitario A Coruna - CHUAC /ID# 203909
- Hospital Universitario Vall d'Hebron /ID# 202721
- Hospital Clinic de Barcelona /ID# 202726
- Hospital Universitario de Girona Doctor Josep Trueta /ID# 202644
- Hospital Juan Ramon Jimenez /ID# 202727
- Hospital Universitario La Paz /ID# 202725
- Hospital Universitario de Salamanca /ID# 206359
- Hospital Universitario Virgen Macarena /ID# 202722
- Hospital Clinico Universitario de Valencia /ID# 209658
- Hospital Universitario y Politecnico La Fe /ID# 202720
- Hallands Hospital Halmstad /ID# 170815
- Karolinska University Hospital Solna /ID# 224489
- Alingsas lasarett /ID# 170814
- Sodra Alvsborgs sjukhus /ID# 203078
- Sahlgrenska University Hospital /ID# 169032
- Sahlgrenska University Hospital /ID# 169170
- Universitatsspital Zurich /ID# 171000
- Inselspital, Universitätsspital Bern /ID# 170994
- China Medical University Hospital /ID# 169803
- Taichung Veterans General Hospital /ID# 169802
- National Taiwan University Hospital /ID# 169805
- Linkou Chang Gung Memorial Hospital /ID# 169804
- Gazi Universitesi Tip Fakultes /ID# 217445
- Acibadem Kozyatagi Hospital /ID# 209404
- Erciyes University Medical Fac /ID# 171325
- Ankara Univ Medical Faculty /ID# 206408
- Inonu Universitesi Turgut Ozal /ID# 201266
- Mustafa Kemal University Medic /ID# 171328
- Istanbul University Istanbul Medical Faculty /ID# 171365
- Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171326
- Mersin University Medical /ID# 171330
- Sisli Etfal Train & Res Hosp /ID# 171327
- Medical Centre of "Ukrainian German Antiulcer Gastroenterology Centre BYK-KYIV" /ID# 203739
- Kharkiv City Clinical Hospital No.2 n.a. Prof. O.O. Shalimov /ID# 167918
- Kyiv Municipal Clinical Hospital #18 /ID# 207890
- MNI KRC Kyiv Regional Clinical Hospital /ID# 202456
- Lviv Railway Clinical Hospital of branch Healthcare Centers of Public Joint Stoc /ID# 167917
- CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 222111
- South Eastern Health and Social Care Trust /ID# 205324
- Warrington and Halton Hospitals NHS Foundation Trust /ID# 171396
- Barts Health NHS Trust /ID# 218830
- Royal United Hospitals Bath /ID# 169062
- University Hospitals Birmingham NHS Foundation Trust /ID# 169058
- The Dudley Group NHS Foundation Trust /ID# 169057
- London North West University Healthcare NHS Trust /ID# 169056
- King's College Hospital NHS Foundation Trust /ID# 169060
- The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 169063
- St.Helens and Knowsley Teaching Hospitals NHS Trust /ID# 209087
- Stockport NHS foundation trust /ID# 208717
- Taunton and Somerset NHS Foundation Trust /ID# 209666
- St George's University Hospitals NHS Foundation Trust /ID# 205550
- The Royal Wolverhampton NHS Trust /ID# 171395
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Substudy 1: Cohort 1 Upadacitinib Dose A
Substudy 1: Cohort 1 Upadacitinib Dose B
Substudy 1: Cohort 1 Placebo
Substudy 1: Cohort 2 Placebo
Substudy 1: Cohort 3 Upadacitinib Dose B
Substudy 2: Cohort 4 Upadacitinib Dose B
Substudy 2: Cohort 5 Upadacitinib Dose A
Substudy 2: Cohort 5 Upadacitinib Dose B
Substudy 2: Cohort 5 Placebo
Substudy 3: Cohort 6 Upadacitinib Dose A
This is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive upadacitinib dose A for 52 weeks.
This is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive upadacitinib dose B for 52 weeks.
This is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive placebo for 52 weeks.
This is a maintenance group which includes participants who received double-blind placebo in studies M14-431 and M14-433 and achieved clinical response will continue to receive blinded placebo for 52 Weeks.
This is a maintenance group which includes participants who achieved clinical response to upadacitinib from the extended treatment period of studies M14-431 and M14-433 and will receive upadacitinib Dose B for 52 Weeks.
This is a long-term extension group which includes participants who achieved clinical response in the open-label extended treatment period of study M14-431 and will receive upadacitinib dose B for 240 weeks.
This is a long-term extension group which includes participants who complete Substudy 1 and will receive upadacitinib dose A for 240 weeks.
This is a long-term extension group which includes participants who complete Substudy 1 and will receive upadacitinib dose B for 240 weeks.
This is a long-term extension group which includes participants who complete Substudy 1 and will receive placebo for 240 weeks.
This is the dose optimization group which includes participants from Substudy 2 who meet the criteria of stable remission will receive open-label upadacitinib dose A for up to 48 weeks.