A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC)
Ulcerative Colitis (UC)
About this trial
This is an interventional treatment trial for Ulcerative Colitis (UC) focused on measuring Ulcerative Colitis (UC), Upadacitinib (ABT-494), Long Term Extension (LTE), Safety, Efficacy, RINVOQ
Eligibility Criteria
Inclusion Criteria:
Note: Participants aged 16 or 17 may enroll in M14-234 or M14-675 where locally permissible
- Participant has not achieved clinical response at the end of the induction period (Week 8) in Study M14-234 Substudy 1, has had loss of response during the maintenance period of Study M14-234 Substudy 3, or has successfully completed Study M14-234 Substudy 3. During the COVID-19 pandemic, for participants with missing endoscopy at Week 8, Week 16 or Week 52 due to the COVID-19 pandemic in Studies M14-234 Substudy 2, M14-234 Substudy 3 and M14-675, participants may be enrolled if certain criteria are met.
- If female, participant must meet the criteria for Contraception Recommendations.
- Women of childbearing potential must have a negative urine pregnancy test at Week 0 visit.
- Participant is judged to be in otherwise good health as determined by the principal investigator based upon clinical evaluations performed during the preceding study (Study M14-234).
- Must be able and willing to give written informed consent and to comply with the requirements of this study protocol.
Exclusion Criteria:
- For any reason participant is considered by the investigator to be an unsuitable candidate.
- Female participant with a positive pregnancy test at the final visit of Study M14-234 or who is considering becoming pregnant during the study or within 30 days after the last dose of study drug.
- Participant with an active or recurrent infection that based on the investigator's clinical assessment makes the participant an unsuitable candidate for the study. Participants with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection has been successfully treated.
- Current evidence of active tuberculosis (TB); current evidence of latent tuberculosis and for any reason the participant cannot take full course of TB prophylaxis treatment as required per protocol.
- Participant with a poorly controlled medical condition, such as uncontrolled diabetes, unstable ischemic heart disease, moderate or severe congestive heart failure (New York Heart Association class III or IV), recent cerebrovascular accidents and any other condition which, in the opinion of the investigator or sponsor, would put the subject at risk by participation in this study.
- Participants have malignancy, high-grade dysplasia, un-removed low-grade dysplasia of the gastrointestinal tract diagnosed at the endoscopy performed at the final visit of Study M14-234.
- History of any malignancy except for successfully treated nonmelanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix from evaluations performed in Study M14-234.
Sites / Locations
- East View Medical Research, LLC /ID# 171184
- CB Flock Research Corporation /ID# 165986
- Delsol Research Management, Ll /Id# 170130
- Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211886
- Arizona Arthritis & Rheumatology Research, PLLC /ID# 169823
- Adobe Clinical Research LLC /ID# 155249
- University of Arizona /ID# 150568
- Citrus Valley Gastroenterology /ID# 151915
- Newport Huntington Medical Group /ID# 217006
- UC San Diego Health System /ID# 155187
- United Medical Doctors /ID# 207467
- TLC Clinical Research Inc /ID# 216830
- Gastrointestinal Biosciences Clinical Trials, LLC /ID# 157082
- Facey Medical Foundation /ID# 203135
- United Medical Doctors - Murrieta /ID# 151213
- InSite Digestive Health Care - Oxnard /ID# 163417
- Inland Empire Clinical Trials, LLC /ID# 216163
- San Diego Clinical Trials /ID# 212121
- Medical Assoc Research Grp /ID# 169149
- Univ of California San Francis /ID# 164583
- Delta Waves, Inc. /ID# 151727
- South Denver Gastroenterology /ID# 151224
- Western States Clinical Res /ID# 158078
- Western Connecticut Medical Group /ID# 169211
- Medical Research Center of CT /ID# 150534
- West Central Gastroenterology /ID# 155242
- Moonshine Research Center, Inc /ID# 152534
- Universal Axon Clinical Research /ID# 213463
- Palmetto Research, LLC /ID# 151724
- Nature Coast Clinical Research - Inverness /ID# 154070
- Encore Borland-Groover Clinical Research /Id# 170913
- SIH Research Mumtaz, Inc /ID# 163199
- Cfagi Llc /Id# 202018
- University of Miami /ID# 215443
- Advanced Pharma CR, LLC /ID# 151723
- New Horizon Research Center /ID# 152475
- Crystal Pharmacology Research /ID# 151848
- Coral Research Clinic /ID# 150524
- Advanced Research Institute, Inc /ID# 163093
- Endoscopic Research, Inc. /ID# 151725
- Omega Research Group /ID# 200271
- Clinical Research Trials of Florida, Inc. /ID# 201791
- University of South Florida /ID# 214494
- AdventHealth Tampa /ID# 200274
- Gastroenterology Associates of Central Georgia, LLC /ID# 165783
- Infinite Clinical Trials /ID# 215342
- Atlanta Gastroenterology Spec /ID# 150565
- Next Innovative Clinical Research - Chicago /ID# 217323
- The University of Chicago DCAM /ID# 150564
- NorthShore University HealthSystem /ID# 150570
- Northwest Health Care Associates /ID# 151591
- Carle Foundation Hospital /ID# 151155
- MediSphere Medical Research Center /ID# 152080
- Indianapolis Gastroenterology /ID# 162914
- University of Iowa Hospitals and Clinics /ID# 157059
- Cotton O'Neil Clinical Research Center, Digestive Health /ID# 167183
- Tri-State Gastroenterology /ID# 169812
- Houma Digestive Health Special /ID# 151851
- Nola Research Works, LLC /ID# 153365
- Louisiana Research Center, LLC /ID# 150526
- University of Maryland Med Ctr /ID# 150529
- Gastro Center of Maryland /ID# 200024
- Massachusetts General Hospital /ID# 165678
- University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 151158
- Huron Gastroenterology Assoc /ID# 152712
- Clin Res Inst of Michigan, LLC /ID# 153031
- Clin Res Inst of Michigan, LLC /ID# 161983
- Revival Research Institute, LLC /ID# 207281
- Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 157487
- Mayo Clinic - Rochester /ID# 151681
- Minnesota Gastroenterology PA /ID# 151682
- University of Mississippi Medical Center /ID# 213140
- Southern Therapy and Advanced Research (STAR) LLC /ID# 170713
- Washington University-School of Medicine /ID# 150537
- Las Vegas Medical Research /ID# 153052
- Dartmouth-Hitchcock Medical Center /ID# 150566
- Cooper Gastroenterology at Fire Road /ID# 153048
- Atlantic Digestive Health Inst /ID# 150527
- Rutgers Robert Wood Johnson /ID# 155247
- Duplicate_University of New Mexico Department of Internal Medicine /ID# 214399
- Montefiore Medical Center - Moses Campus /ID# 150559
- Advantage Clinical Trials /ID# 163940
- NY Scientific /ID# 152708
- NYU Langone Long Island Clinical Research Association /ID# 155271
- Columbia Univ Medical Center /ID# 163409
- DiGiovanna Institute for Medical Education & Research /ID# 201534
- Premier Medical Group - GI Division /ID# 153366
- Gastoenterology Group of Rochester /ID# 151080
- Richmond University Medical Center /ID# 201860
- Digestive Health Partners, P.A /ID# 167238
- Atrium Health Carolinas Medical Center /ID# 157060
- Charlotte Gastroenterology and Hepatology, PLLC /ID# 150561
- Atlantic Gastroenterology Clinical Research /ID# 151901
- Clinical Trials of America /ID# 153453
- Wake Forest Baptist Medical Center /ID# 150528
- Plains Clinical Research Center, LLC /ID# 170291
- Gastro Health Research /ID# 151683
- University of Cincinnati /ID# 164584
- The Ohio State University /ID# 169417
- Optimed Research, Ltd. /ID# 169697
- Hometown Urgent Care and Resea /ID# 200066
- Dayton Gastroenterology, Inc. /ID# 167632
- Great Lakes Gastroenterology Research, LLC /ID# 201773
- Ohio Clinical Research Partner /ID# 154074
- Hightower Clinical /ID# 216338
- Digestive Disease Specialists /ID# 201057
- Options Health Research, LLC /ID# 150569
- Healthcare Research Consultant /ID# 163096
- Northwest Gastroenterology Clinic /ID# 152528
- Guthrie Medical Group, PC /ID# 150533
- Penn State Health Colonnade /ID# 150267
- Pharmacorp Clinical Trials /ID# 153363
- Gastroenterology Associates, P.A. of Greenville /ID# 150557
- Gastro One /ID# 151154
- East Tennessee Research Institute /ID# 203611
- Quality Medical Research /ID# 203427
- Vanderbilt University Medical Center /ID# 153364
- TX Clinical Research Institute /ID# 151528
- Inquest Clinical Research /ID# 164636
- Texas Digestive Disease Consultants /ID# 209949
- GI Alliance /ID# 209806
- Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 200771
- DHAT Research Institute /ID# 151221
- Vilo Research Group Inc /ID# 212626
- CliniCore International, LLC /ID# 152078
- Baylor College of Medicine - Baylor Medical Center /ID# 150538
- Centex Studies, Inc. - Houston /ID# 201217
- GI Specialists of Houston /ID# 202337
- Caprock Gastro Research, LLC /ID# 215116
- Clinical Associates in Research Therapeutics of America, LLC /ID# 167954
- Southern Star Research Institute, LLC /ID# 169397
- Carl R. Meisner Medical Clinic /ID# 171270
- Baylor Scott & White Center for Diagnostic Medicine /ID# 204777
- Tyler Research Institute, LLC /ID# 169147
- Gastro Health & Nutrition - Victoria /ID# 167764
- HP Clinical Research /ID# 163941
- Advanced Research Institute /ID# 162640
- Utah Gastroenternology - St. Mark's Office /ID# 163097
- Velocity Clinical Research - Salt Lake City /ID# 163180
- Ctr for Gastrointestinal Healt /ID# 153369
- Washington Gastroenterology /ID# 163630
- Virginia Mason Medical Center /ID# 153030
- The Polyclinic /ID# 165117
- The Vancouver Clinic, INC. PS /ID# 162334
- Aurora Medical Center - Grafto /ID# 151726
- Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 151845
- Medical College of Wisconsin /ID# 151850
- Cardio Alem /ID# 211281
- Gedyt /ID# 210016
- Mautalen Salud e Investigacion /ID# 171174
- Hospital Britanico de Buenos Aires /ID# 209496
- Sanatorio 9 de Julio /ID# 150215
- Hospital Privado Univesitario /ID# 164186
- Macquarie University Hospital /ID# 211953
- Mater Misericordiae Limited /ID# 212686
- Griffith University /ID# 211954
- Monash Medical Centre /ID# 150218
- St Vincent's Hospital Melbourne /ID# 152503
- Fiona Stanley Hospital /ID# 211641
- Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 150462
- Klinik Landstrasse /ID# 162867
- Medizinische Universitaet Wien /ID# 150616
- Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 150463
- Vitebsk Regional Advanced Clin /ID# 169592
- Universitair Ziekenhuis Leuven /ID# 150468
- AZ-Delta /ID# 150467
- AZ Maria Middelares /ID# 150466
- University Clinical Centre of the Republic of Srpska /ID# 150223
- University Clinical Centre of the Republic of Srpska /ID# 150712
- University Clinical Center Tuzla /ID# 150224
- University Clinical Hospital Mostar /ID# 150711
- Clinical Center University of Sarajevo /ID# 150222
- Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 153744
- Hospital Nossa Senhora das Graças /ID# 152488
- Hospital de Clinicas de Porto Alegre /ID# 153745
- Upeclin Fmb - Unesp /Id# 152493
- Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 152492
- Faculdade de Medicina do ABC /ID# 152489
- Kaiser Clinica e Hospital Dia /ID# 152491
- University of Calgary /ID# 151818
- Allen Whey Khye Lim Professional Corporation /ID# 211169
- University of Alberta - Zeidler Ledcor Centre /ID# 151824
- Covenant Health /ID# 158931
- OCT Research ULC /ID# 153179
- Percuro Clinical Research, Ltd /ID# 150479
- Hamilton Health Sciences - McMaster University Medical Centre /ID# 150477
- Ottawa Hospital Research Institute /ID# 151817
- Medicor Research Inc /ID# 151825
- Toronto Digestive Disease Associates, Inc. /ID# 150475
- CISSS de la Monteregie /ID# 159271
- Duplicate_CISSS de Chaudière-Appalaches, Hôpital Hotel-Dieu de Lévis /ID# 150473
- Recherche GCP Research /ID# 151819
- Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 167170
- Montreal General Hospital - McGill University Health Centre /ID# 170013
- CIUSSS de l'Estrie - CHUS /ID# 150478
- Research Group /ID# 203177
- M y F Estudios Clínicos /ID# 200112
- Centro de Investigaciones Clínicas Viña del Mar /ID# 150226
- Hospital Guillermo Grant Benavente de Concepción /ID# 212425
- CTR Estudios Clinicos /ID# 200111
- Hospital Clinico Universidad De Los Andes /ID# 207427
- The First Affiliated Hospital, Sun Yat-sen University /ID# 150517
- The Sixth Affiliated Hosp Sun /ID# 150518
- Affiliated Taihe Hospital of Hubei University of Medicine /ID# 216407
- Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 167089
- Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167079
- Xiangya Hospital Central South University /ID# 167230
- The First Affiliated Hospital of Nanchang University /ID# 212185
- The First Hospital of Jilin University /ID# 210087
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 150523
- Shanghai Tenth People's Hospital /ID# 150522
- Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 165826
- West China Hospital, Sichuan University /ID# 167041
- The second Affiliated hospital of Zhejiang University school of Medicine /ID# 165813
- Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 150516
- Shengjing Hospital of China Medical University /ID# 166921
- Tianjin Medical University General Hospital /ID# 170605
- Oncomedica SAS /ID# 207052
- Coorp Hosp Juan Ciudad Sede Hospital Universitario Mayor Mederi /ID# 152811
- Hospital Universitario de San /ID# 155388
- Klinicka bolnica Dubrava Zagreb /ID# 150228
- Klinicki bolnicki centar Zagreb /ID# 150262
- Klinicki bolnicki centar Zagreb /ID# 150715
- Duplicate_Klinicki bolnicki centar Osijek /ID# 150229
- Klinicki bolnicki centar Rijeka /ID# 150714
- Klinicki bolnicki centar Split /ID# 213989
- Poliklinika Solmed /ID# 211567
- Zadar General Hospital /ID# 150261
- Hepato-Gastroenterologie HK, s.r.o. /ID# 150946
- CTCenter MaVe s.r.o. /ID# 150903
- ARTROSCAN s.r.o. /ID# 150502
- Nemocnice Pardubickeho kraje, a.s. /ID# 213541
- Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 216224
- Axon Clinical, s.r.o. /ID# 152477
- ISCARE a.s. /ID# 209279
- North Estonia Medical Centre /ID# 160871
- East Tallinn Central Hospital /ID# 150488
- Tartu University Hospital /ID# 150489
- West Tallinn Central Hospital /ID# 150490
- Tampere University Hospital /ID# 150376
- Duplicate_Helsinki Univ Central Hospital /ID# 154283
- Keski-Suomen Sairaala Nova /ID# 155665
- Laakarikeskus Ikioma /ID# 150377
- Turku University Hospital /ID# 169895
- Chu de Nice-Hopital L'Archet Ii /Id# 152608
- HCL - Hopital Lyon Sud /ID# 152540
- CHRU Lille - Hopital Claude Huriez /ID# 152609
- CHU Montpellier - Hôpital Saint Eloi /ID# 200088
- CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 165749
- CHU de Saint-Etienne, Hopital Nord /ID# 165756
- Universitatsklinikum Mannheim /ID# 150405
- Universitaetsklinikum Muenster /ID# 150402
- Gastroenterologische Gemeinschaftspraxis Herne /ID# 214575
- Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 215812
- Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 161871
- MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 151697
- Agaplesion Markus Krankenhaus /ID# 161870
- Medizinisches Versorgungszentrum Portal 10 /ID# 207136
- Universitätsklinikum Tübingen /ID# 151698
- Praxis medicum /ID# 150404
- General Hospital of Athens Laiko /ID# 208672
- General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202101
- University General Hospital of Heraklion PA.G.N.I /ID# 150236
- General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 150406
- University General Hospital of Ioannina /ID# 164247
- Theageneio Anticancer Hospital /ID# 164187
- General Hospital of Thessaloniki Hippokrateio /ID# 209522
- Markusovszky Egyetemi Oktatokorhaz /ID# 150410
- Bekes Megyei Kozponti Korhaz /ID# 151601
- Semmelweis Egyetem /ID# 150409
- Meditres Kft. /ID# 151597
- Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 151599
- Mentahaz Maganorvosi Kozpont /ID# 206977
- Beaumont Hospital /ID# 150414
- St James Hospital /ID# 150413
- St Vincent's University Hospital /ID# 150411
- Mercy University Hospital /ID# 153794
- University Hospital Galway /ID# 150412
- Soroka University Medical Center /ID# 156562
- Hadassah Medical Center-Hebrew University /ID# 165119
- Rambam Health Care Campus /ID# 150416
- Shaare Zedek Medical Center /ID# 163139
- Azienda Ospedaliera San Camillo Forlanini /ID# 151362
- ASST Rhodense/Presidio Ospedaliero di Rho /ID# 216673
- Istituto Clinico Humanitas /ID# 151363
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 150425
- Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 150420
- IRCCS Ospedale Sacro Cuore Don Calabria /ID# 201726
- IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 150424
- ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 150605
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 150421
- A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 150263
- Aichi Medical University Hospital /ID# 151994
- Nagoya City University Hospital /ID# 151949
- Nagoya University Hospital /ID# 152728
- Toyohashi Municipal Hospital /ID# 171470
- Ieda Hospital /ID# 157782
- National Hospital Organization Hirosaki General Medical Center /ID# 152761
- Tokatsu Tsujinaka Hospital /ID# 214964
- Tsujinaka Hospital Kashiwanoha /ID# 209572
- Toho University Sakura Medical Center /ID# 151935
- Juntendo University Urayasu Hospital /ID# 208783
- Fukui Prefectural Hospital /ID# 210450
- Fukuoka University Chikushi Hospital /ID# 152627
- Saiseikai Fukuoka Genaral Hospital /ID# 209481
- Kyushu University Hospital /ID# 152525
- Kitakyushu Municipal Medical Center /ID# 152589
- Kurume University Hospital /ID# 151977
- Ogaki Municipal Hospital /ID# 208226
- NHO Fukuyama Medical Center /ID# 206294
- Hiroshima University Hospital /ID# 151952
- Asahikawa Medical University Hospital /ID# 170281
- Obihiro kosei Hospital /ID# 210425
- Sapporo Tokushukai Hospital /ID# 209449
- Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 151705
- Sapporo Medical University Hospital /ID# 206493
- Sapporo Higashi Tokushukai Hospital /ID# 208495
- Aoyama Clinic /ID# 152048
- Hyogo Medical University Hospital /ID# 152433
- National Hospital Organization Mito Medical Center /ID# 152626
- Kanazawa University Hospital /ID# 207810
- Iwate Medical University Uchimaru Medical Center /ID# 203412
- Imamura General Hospital /ID# 227138
- Idzuro Imamura Hospital /ID# 207640
- Sameshima Hospital /ID# 206673
- Kagoshima IBD Gastroenterology Clinic /ID# 245222
- St. Marianna University Hospital /ID# 209452
- Yokohama City University Medical Center /ID# 169900
- Showa University Fujigaoka Hospital /ID# 208223
- Japanese Red Cross Kyoto Daiichi Hosital /ID# 152358
- Kyoto University Hospital /ID# 211808
- Mie University Hospital /ID# 207253
- Yokkaichi Hazu Medical Center /ID# 214349
- National Hospital Organization Sendai Medical Center /ID# 209529
- NHO Nagasaki Medical Center /ID# 210821
- Kenseikai Dongo Hospital /ID# 208102
- Saiseikai Niigata Hospital /ID# 209923
- Niigata University Medical & Dental Hospital /ID# 218050
- Ishida Clinic of IBD and Gastroenterology /ID# 210118
- Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 157820
- Okayama University Hospital /ID# 217924
- Kinshukai Infusion Clinic /ID# 207866
- Kitano Hospital, Tazuke Kofukai Medical Research Institute /ID# 210396
- Osaka City General Hospital /ID# 152703
- Japanese Red Cross Osaka Hospital /ID# 209477
- Osaka Metropolitan University Hospital /ID# 152681
- Toyonaka Municipal Hospital /ID# 217083
- Saga University Hospital /ID# 209272
- Saitama Medical Center /ID# 152019
- Tokitokai Tokito clinic /ID# 152676
- National Hospital Organization Higashi-Ohmi General Medical Center /ID# 210711
- Shimane University Hospital /ID# 208906
- Hamamatsu University Hospital /ID# 205709
- NHO Shizuoka Medical Center /ID# 163571
- Tokyo Medical And Dental University Hospital /ID# 152017
- St.Luke's International Hospital /ID# 208075
- Tokai University Hachioji Hospital /ID# 152584
- Teikyo University Hospital /ID# 209865
- Kitasato University Kitasato Institute Hospital /ID# 152687
- Kyorin University Hospital /ID# 153195
- Center Hospital of the National Center for Global Health and Medicine /ID# 209533
- Tokyo Women's Medical University Hospital /ID# 205978
- Yamagata University Hospital /ID# 171468
- Tokuyama Central Hospital /ID# 216995
- Yamanashi Prefectural Central Hospital /ID# 151909
- Shoyukai Fujita Gastroenterological Hospital /ID# 216494
- Hanyang University Gurihospital /ID# 150431
- CHA University Bundang Medical Center /ID# 161567
- The Catholic University of Korea, ST. Vincent's Hospital /ID# 150434
- Kangbuk Samsung Hospital /ID# 150435
- Yonsei University Health System Severance Hospital /ID# 161566
- Dong-A University Hospital /ID# 161568
- Pusan National University Hospital /ID# 161569
- Yeungnam University Medical Center /ID# 150432
- Asan Medical Center /ID# 159155
- Samsung Medical Center /ID# 150433
- VCA Polyclinic Aura /ID# 150436
- Pauls Stradins Clinical University Hospital /ID# 153183
- Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 150439
- Klaipeda university hospital /ID# 163501
- Klaipeda University Hospital /ID# 163719
- Vilnius University Hospital /ID# 164172
- Hospital Sultanah Bahiyah /ID# 152310
- Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 152313
- Hospital Ampang /ID# 152311
- Uni Malaya MC /ID# 150440
- Morales Vargas Centro de Investigacion S.C. /ID# 211327
- Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 202334
- Centro Regiomontano de Estudios Clínicos ROMA S.C /ID# 150265
- Radboud Universitair Medisch Centrum /ID# 151701
- Erasmus Medisch Centrum /ID# 150619
- Academisch Medisch Centrum /ID# 150617
- Leids Universitair Medisch Centrum /ID# 152625
- Universitair Medisch Centrum Utrecht /ID# 152776
- Akershus Universitetssykehus_MAIN /ID# 150622
- Universitetssykehuset Nord-Norge /ID# 152836
- Gastromed Sp. z o.o /ID# 216198
- Centrum Zdrowia MDM /ID# 150626
- Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 150627
- Centrum Medyczne Reuma Park /ID# 150624
- NZOZ Vivamed Jadwiga Miecz /ID# 216743
- Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 215733
- Endoskopia Sp. z o.o. /ID# 152940
- Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 151616
- Centro Hospitalar de Entre Douro e Vouga /ID# 152336
- Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 151618
- Hospital Garcia de Orta, EPE /ID# 151622
- CCA Braga - Hospital de Braga /ID# 151617
- Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 151620
- Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 151615
- Centro Hospitalar Universitario de Sao Joao, EPE /ID# 151619
- School of Medicine University of Puerto Rico-Medical Science Campus /ID# 150629
- Immanuel Kant Baltic Federal University /ID# 202129
- NW State Medical Univ na Mechn /ID# 169332
- Perm Clinical Center of the Federal Medical and Biological Agency /ID# 150634
- Medical Company Hepatolog /ID# 200208
- LLC Novaya Klinika /ID# 208106
- Kazan State Medical University /ID# 166040
- Olla-Med Clinic /ID# 215334
- Republican hospital named after V.A. Baranov /ID# 206508
- Euromedservice /ID# 208968
- Duplicate_Stavropol State Medical Univ /ID# 150635
- Clinical Hosp Center Zvezdara /ID# 150641
- Military Medical Academy /ID# 150643
- University Clinical Center Serbia /ID# 150642
- Clin Hosp Ctr Bezanijska Kosa /ID# 150640
- University Clinical Center of Nis /ID# 151902
- University Clinical Center Kragujevac /ID# 150644
- Clinical Center Vojvodina /ID# 150759
- General Hospital Leskovac /ID# 217882
- National University Hospital /ID# 150583
- Gleneagles Medical Centre /ID# 206020
- Tan Tock Seng Hospital /ID# 150646
- Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 150869
- Medak s.r.o. /ID# 150550
- Slovak Research Center Team Me /ID# 150240
- B+B MED, s.r.o. /ID# 150584
- Fakultna nemocnica s poliklinikou Nove Zamky /ID# 211371
- GASTRO I., s.r.o. /ID# 150585
- MD Search /ID# 157524
- Clinresco Centers /ID# 163625
- Lenasia Clinical Trial Centre /ID# 214361
- Wits Clinical Research , Wits Health Consortium (PTY) Ltd /ID# 157730
- Wits Clinical Research Site /ID# 150586
- Spoke Research Inc /ID# 162203
- Kingsbury Hospital /ID# 150587
- Private Practice Dr MN Rajabally /ID# 155145
- Hospital Clínico Universitario de Santiago-CHUS /ID# 171492
- Hospital Unversitario Marques de Valdecilla /ID# 216621
- Hospital Universitario Dr. Negrin /ID# 203965
- Hospital Universitario A Coruna - CHUAC /ID# 203912
- Hospital Clinic de Barcelona /ID# 150598
- Hospital Universitario Reina Sofia /ID# 154031
- Hospital Universitario Ramon y Cajal /ID# 171491
- Hospital Universitario La Paz /ID# 214541
- Hospital Universitario de Salamanca /ID# 150590
- Hospital Universitario y Politecnico La Fe /ID# 150591
- Sahlgrenska University Hospital /ID# 152326
- Universitätsspital Basel /ID# 161732
- Kantonsspital St. Gallen /ID# 152601
- Universitatsspital Zurich /ID# 152603
- Inselspital, Universitätsspital Bern /ID# 152602
- Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 150606
- Chung Shan Medical University Hospital /ID# 150603
- China Medical University Hospital /ID# 150600
- National Cheng Kung University Hospital /ID# 151751
- National Taiwan University Hospital /ID# 150604
- Taipei Veterans General Hosp /ID# 151750
- Gazi Universitesi Tip Fakultes /ID# 150493
- Erciyes University Medical Fac /ID# 150495
- Istanbul University Cerrahpasa Faculty of Medicine /ID# 150491
- Umraniye Training and Res Hosp /ID# 163136
- Marmara University Medical Fac /ID# 214573
- Mersin University Medical /ID# 163135
- Medical Center of the "Health /ID# 162501
- Municipal Enterprise "I.I. Mechnikov Dnipropetrovsk Regional Clinical Hospital" /ID# 207731
- CNCE of Kharkiv Regional Council Regional Clinical Hospital /ID# 206941
- PE PMC Acinus, Medical and Diagnostic Center /ID# 217219
- Kyiv Municipal Clinical Hospital #18 /ID# 150505
- Medical Center CONSILIUM MEDICAL /ID# 217448
- CNPE of Kyiv Regional Council Kyiv Regional Hospital /ID# 217374
- Lviv Regional Clinical Hospital /ID# 150508
- Municipal Non-Commercial Enterprise Odesa Regional Clinical Hospital of the Od /ID# 162502
- CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 216302
- Royal Devon University Healthcare NHS Foundation Trust /ID# 150510
- Hampshire Hospitals NHS Foundation Trust /ID# 150511
- Barts Health NHS Trust /ID# 150515
- NHS Greater Glasgow and Clyde /ID# 163788
- Royal United Hospitals Bath /ID# 154211
- University Hospitals Birmingham NHS Foundation Trust /ID# 150513
- Calderdale and Huddersfield NHS Foundation Trust /ID# 217659
- St George's University Hospitals NHS Foundation Trust /ID# 208376
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Participants receiving Upadacitinib (ABT-494) Dose A
Participants receiving Upadacitinib (ABT-494) Dose B
Participants receiving Upadacitinib (ABT-494) Dose C
Participants receiving Placebo
Participants receiving Upadacitinib (ABT-494) Dose A or Dose B
The participants in this arm will receive Upadacitinib (ABT-494) dose A.
The participants in this arm will receive Upadacitinib (ABT-494) dose B.
The participants in this arm will receive Upadacitinib (ABT-494) dose C.
The participants in this arm will receive placebo until study is unblinded.
The participants in this arm will receive Upadacitinib (ABT-494) dose A or dose B.