A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy
Crohn's Disease
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Upadacitinib, Crohn's Disease, Efficacy, Safety
Eligibility Criteria
Inclusion Criteria:
- Confirmed diagnosis of CD for at least 3 months prior to Baseline.
- Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score.
- Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader.
- Demonstrated an inadequate response or intolerance to any biologic therapy for infliximab, adalimumab, certolizumab pegol, vedolizumab, and ustekinumab.
- If female, participant must meet the contraception recommendations.
Exclusion Criteria:
- Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
- Participant not on stable doses of CD related antibiotics, oral aminosalicylates, corticosteroids or methotrexate (MTX).
- Participant with the following ongoing known complications of CD: abscess (abdominal or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
- Participant with ostomy or ileoanal pouch.
- Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short gut or short bowel syndrome.
- Screening laboratory and other protocol pre-specified analyses show abnormal results.
Sites / Locations
- East View Medical Research, LLC /ID# 171133
- CB Flock Research Corporation /ID# 166220
- Delsol Research Management, Ll /Id# 170179
- HonorHealth Research Institute - Shea /ID# 164734
- Arizona Arthritis & Rheumatology Research, PLLC /ID# 203891
- Southern California Res. Ctr. /ID# 169654
- Citrus Valley Gastroenterology /ID# 166201
- United Medical Doctors /ID# 207452
- Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164887
- Facey Medical Foundation /ID# 203137
- United Medical Doctors - Murrieta /ID# 164845
- Ucsd /Id# 164679
- Medical Assoc Research Grp /ID# 169705
- UCSF Center for Colitis and Crohn's Disease /ID# 202373
- Univ of California San Francis /ID# 164843
- Care Access Research /ID# 167766
- Peak Gastroenterology Associates, PC /ID# 170181
- Delta Waves, Inc. /ID# 164872
- Duplicate_Western States Clinical Research, Inc. /ID# 164895
- Medical Research Center of CT /ID# 164829
- Clinical Research of West Florida, Inc /ID# 205825
- Clinical Research of West Florida, Inc /ID# 208117
- Advanced Research - Coral Springs /ID# 218020
- Encore Borland-Groover Clinical Research /Id# 203498
- Ctr for Advanced Gastroenterol /ID# 165332
- Crystal Pharmacology Research /ID# 166101
- Coral Research Clinic /ID# 164657
- Advanced Research Institute, Inc /ID# 164814
- Endoscopic Research, Inc. /ID# 205893
- Omega Research Maitland, LLC /ID# 203480
- Clinical Research Trials of Florida, Inc. /ID# 203484
- AdventHealth Tampa /ID# 171175
- Gastroenterology Associates of Central Georgia, LLC /ID# 165460
- Gastroenterology Consultants PC - Roswell /ID# 218219
- Atlanta Gastroenterology Spec /ID# 164780
- University of Chicago Medicine /ID# 165472
- DuPage Medical Group /ID# 205303
- MediSphere Medical Research Center /ID# 166209
- Indianapolis Gastroenterology /ID# 164837
- Aquiant Research /ID# 205504
- University of Iowa Hospitals and Clinics /ID# 165330
- Tri-State Gastroenterology /ID# 165484
- University of Louisville /ID# 168536
- University of Louisville /ID# 208093
- CroNOLA, LLC /ID# 164722
- Nola Research Works, LLC /ID# 164897
- Louisana Research Center, LLC /ID# 164659
- Johns Hopkins University School of Medicine /ID# 211940
- MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 164835
- Gastro Center of Maryland /ID# 171171
- Lahey Hospital and Medical Center /ID# 214725
- University of Michigan Health Systems /ID# 164844
- Clin Res Inst of Michigan, LLC /ID# 170178
- Digestive Health Associates (DHA) - Farmington Hills /ID# 206099
- Center for Digestive Health /ID# 164733
- Mayo Clinic - Rochester /ID# 164868
- Southern Therapy and Advanced Research (STAR) LLC /ID# 165318
- Quality Clinical Research Inc. /ID# 170177
- CHI Health Research Center /ID# 168545
- Las Vegas Medical Research /ID# 168562
- AGA Clinical Research Associates, LLC /ID# 164883
- Rutgers Robert Wood Johnson /ID# 166092
- Montefiore Medical Center - Moses Campus /ID# 166226
- Advantage Clinical Trials /ID# 168557
- NY Scientific /ID# 164833
- NYU Langone Long Island Clinical Research Associates /ID# 164830
- The Mount Sinai Hospital /ID# 170172
- Columbia Univ Medical Center /ID# 164870
- Gastro Group of Rochester /ID# 166216
- Richmond University Medical Center /ID# 201855
- Atrium Health Carolinas Medical Center /ID# 164834
- PMG Research of Charlotte /ID# 171170
- Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 164663
- Wake Forest Baptist Medical Center /ID# 201225
- Plains Clinical Research Center, LLC /ID# 170184
- Consultants for Clinical Research /ID# 164855
- University of Cincinnati /ID# 164720
- Cleveland Clinic Main Campus /ID# 208220
- The Ohio State University /ID# 170174
- Optimed Research, Ltd. /ID# 205618
- Hometown Urgent Care and Resea /ID# 201290
- Dayton Gastroenterology, Inc. /ID# 167624
- Great Lakes Medical Research, LLC /ID# 202007
- Digestive Disease Specialists /ID# 201062
- Options Health Research, LLC /ID# 164737
- Healthcare Research Consultant /ID# 166228
- University of Pennsylvania /ID# 168402
- Thomas Jefferson University /ID# 168014
- Pharmacorp Clinical Trials /ID# 164809
- Gastroenterology Associates, P.A. of Greenville /ID# 164880
- Rapid City Medical Center - GI Research /ID# 201734
- Gastro One /ID# 164718
- East Tennessee Research Institute /ID# 203612
- Quality Medical Research /ID# 205262
- Vanderbilt University Medical Center /ID# 164846
- TX Clinical Research Institute /ID# 164848
- Inquest Clinical Research /ID# 164865
- Texas Digestive Disease Consultants /ID# 209952
- Texas Digestive Disease Consultants /ID# 209802
- CliniCore International, LLC /ID# 164662
- Baylor College of Medicine - Baylor Medical Center /ID# 164847
- Centex Studies, Inc. - Houston /ID# 201213
- GI Specialists of Houston /ID# 202338
- Caprock Gastro Research /ID# 215437
- Clinical Associates in Research Therapeutics of America, LLC /ID# 164863
- Southern Star Research Institute, LLC /ID# 169754
- Carl R. Meisner Medical Clinic /ID# 201060
- Tyler Research Institute, LLC /ID# 168681
- Gastro Health & Nutrition - Victoria /ID# 167813
- HP Clinical Research /ID# 164929
- Advanced Research Institute /ID# 164866
- Duplicate_Care Access Research /ID# 164853
- Velocity Clinical Research - Salt Lake City /ID# 166095
- Washington Gastroenterology Associates /ID# 164721
- Virginia Mason - Seattle Orthapedics /ID# 164680
- University of Washington /ID# 164875
- The Vancouver Clinic, INC. PS /ID# 164811
- Froedtert Memorial Lutheran Hospital /ID# 202286
- Allegiance Research Specialists /ID# 165321
- Cardio Alem /ID# 211284
- Hospital Italiano de Buenos Aires /ID# 215543
- Gedyt /ID# 210019
- Cemic /Id# 169184
- Hospital Provincial del Centenario /ID# 171254
- Hospital Privado Univesitario /ID# 169228
- Concord Repatriation General Hospital /ID# 171509
- Coral Sea Clinical Research institute /ID# 212987
- Mater Misericordiae Limited /ID# 204908
- Royal Adelaide Hospital /ID# 171511
- Box Hill Hospital /ID# 203734
- Fiona Stanley Hospital /ID# 171510
- Klinik Landstrasse /ID# 203437
- Medizinische Universitaet Wien /ID# 169462
- Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 214467
- UCL Saint-Luc /ID# 200297
- CHU de Liege Sart Tilman /ID# 200299
- CHU UCL Namur - site Godinne /ID# 200300
- Universitair Ziekenhuis Leuven /ID# 200298
- AZ Sint-Lucas /ID# 200301
- University Clinical Centre of the Republic of Srpska /ID# 208050
- University Clinical Center Tuzla /ID# 210324
- Clinical Center University of Sarajevo /ID# 203885
- Polyclinic and Daily Hospital Dr. Al-Tawil /ID# 217841
- Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 166870
- Hospital Nossa Senhora das Graças /ID# 166869
- Hospital de Clinicas de Porto Alegre /ID# 166872
- Upeclin Fmb - Unesp /Id# 166876
- Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 166874
- Faculdade de Medicina do ABC /ID# 208327
- Kaiser Clinica e Hospital Dia /ID# 166873
- UMHAT Kaspela EOOD /ID# 167617
- Duplicate_Second MHAT Sofia /ID# 167618
- MHAT Trakia /ID# 201678
- University of Calgary - Cumming School of Medicine - Adult Cystic Fibrosis Clini /ID# 166963
- Allen Whey Khye Lim Professional Corporation /ID# 168041
- Covenant Health /ID# 166966
- Fraser Clinical Trials Inc /ID# 166957
- GIRI Gastrointestinal Research Institute /ID# 166964
- QEII - Health Sciences Centre /ID# 169306
- Scott Shulman Medicine Professional Corporation /ID# 169064
- Taunton Surgical Centre /ID# 168039
- The Ottawa Hospital /ID# 212413
- Medicor Research Inc /ID# 166967
- Toronto Digestive Disease Asso /ID# 166961
- CHAU- Hotel-Dieu de Levis /ID# 166958
- Crchum /Id# 170121
- Montreal General Hospital - McGill University Health Center /ID# 170010
- CIUSSS de l'Estrie - CHUS /ID# 170935
- Research Group /ID# 203180
- M y F Estudios Clínicos /ID# 169995
- Hospital Guillermo Grant Benavente de Concepción /ID# 212422
- CTR Estudios Clinicos /ID# 200650
- Hospital Clinico Universidad De Los Andes /ID# 207465
- Zhongshan Hospital Xiamen University /ID# 204985
- Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 205226
- The Sixth Affiliated Hosp Sun /ID# 204049
- Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 204096
- Nanjing Drum Tower Hospital /ID# 204869
- The First Affiliated Hospital of Nanchang University /ID# 204070
- The First Hospital of Jilin University /ID# 206867
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 204072
- The second Affiliated hospital of Zhejiang University school of Medicine /ID# 204078
- Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 204068
- Beijing Friendship Hospital /ID# 204536
- The Second Hospital Central South University /ID# 204075
- Nanfang Hospital of Southern Medical University /ID# 204074
- Duplicate_Tianjin Med Univ General Hosp /ID# 206993
- Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 204069
- Hospital San Vicente de Paul /ID# 200028
- Hospital Pablo Tobon Uribe /ID# 202405
- Clinical Hospital Dubrava /ID# 171186
- Klinicki bolnicki centar Sestre milosrdnice /ID# 171190
- Klinicki bolnicki centar Zagreb /ID# 171201
- Poliklinika Solmed /ID# 211518
- UHC Split /ID# 171206
- Zadar General Hospital /ID# 205534
- Hepato-Gastroenterologie HK, s.r.o. /ID# 171566
- ResTrial s.r.o. /ID# 208652
- ARTROSCAN s.r.o. /ID# 171592
- Nordsjaellands Hospital /ID# 200613
- Herlev Hospital /ID# 200782
- Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 200611
- Duplicate_Sjaellands Universitets Hospital /ID# 200783
- Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171010
- Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171015
- Clinical Research Center, Faculty of Medicine, Cairo university /ID# 209557
- National Hepatology and Tropical Medicine Research Institute /ID# 170990
- Faculty of Medicine Ain Shams Research Institute- Clinical Research Centre /ID# 209565
- Air Force Specialized Hospital /ID# 170995
- Tartu University Hospital /ID# 203140
- Chu de Nice-Hopital L'Archet Ii /Id# 171009
- HCL - Hôpital Lyon Sud /ID# 171014
- CHU Bordeaux - Hopital Haut Lévêque /ID# 207414
- CHRU Lille - Hopital Claude Huriez /ID# 206539
- Duplicate_Hopital Saint Eloi /ID# 170646
- Hopital Beaujon /ID# 171011
- CHU de SAINT ETIENNE - Hopital Nord /ID# 171018
- CHRU Nancy - Hôpitaux de Brabois /ID# 170985
- CHU Amiens-Picardie Site Sud /ID# 171016
- CHRU Tours - Hopital Trousseau /ID# 169786
- Duplicate_CHU Henri Mondor /ID# 169787
- Polyclinique Grand Sud /ID# 170649
- CHU Toulouse - Hopital Rangueil /ID# 169785
- Universitatsklinikum Mannheim /ID# 168778
- Universitaetsklinikum Ulm /ID# 203563
- Universitaetsklinikum Erlangen /ID# 203551
- Universitaetsklinikum Frankfurt /ID# 203565
- Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 206740
- Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 168779
- Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 169067
- Gastroenterologie am Mexikoplatz /ID# 203573
- Universitaetsmedizin Essen St. Josef Krankenhaus Werden /ID# 203571
- Agaplesion Markus Krankenhaus /ID# 168777
- Universitaetsklinikum Halle (Saale) /ID# 207454
- Medizinisches Versorgungszentrum Portal 10 /ID# 200213
- General Hospital of Athens Ippokratio /ID# 167036
- General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202103
- Tzaneio general hospital of Piraeus /ID# 206432
- University General Hospital of Heraklion PA.G.N.I /ID# 167035
- General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 167037
- Genl Hosp Thess Ippokrateio /ID# 208824
- Queen Mary Hospital /ID# 171217
- CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 205546
- Bugat Pal Korhaz /ID# 201889
- Obudai Egeszsegugyi Centrum Kft. /ID# 201891
- Magyar Honvedseg Egeszsegugyi Kozpont /ID# 201719
- Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 201720
- Mentahaz Maganorvosi Kozpont /ID# 201890
- Mercy University Hospital /ID# 206510
- Soroka University Medical Center /ID# 169912
- Tel Aviv Sourasky Medical Center /ID# 204876
- Barzilai Medical Center /ID# 223372
- Assaf Harofeh Medical Center /ID# 204870
- Hadassah Medical Center-Hebrew University /ID# 169927
- Rabin Medical Center /ID# 202635
- Kaplan Medical Center /ID# 170277
- University of Catanzaro /ID# 201920
- Policlinico Universitario Campus Bio-Medico /ID# 168169
- Azienda Ospedaliera San Camillo Forlanini /ID# 168170
- Istituto Clinico Humanitas /ID# 168171
- Fondazione PTV Policlinico Tor Vergata /ID# 168174
- Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 168168
- IRCCS Ospedale Sacro Cuore Don Calabria /ID# 168172
- A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 168173
- A.O. Per L'Emergenza Cannizzaro /ID# 168176
- Policlinico San Martino/Univer /ID# 168177
- ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 168167
- Azienda Ospedaliero-Universitaria di Modena /ID# 200008
- A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 168175
- Azienda Ospedaliero Universitaria Pisana-Stabilimento di Cisanello /ID# 202420
- Aichi Medical University Hospital /ID# 165957
- Nagoya City University Hospital /ID# 165956
- Nagoya University Hospital /ID# 165955
- Toyohashi Municipal Hospital /ID# 200174
- Hirosaki National Hospital /ID# 165944
- Toho University Sakura Medical Center /ID# 165949
- Kurume University Hospital /ID# 166004
- National Hospital Organization Takasaki General Medical Center /ID# 167136
- NHO Fukuyama Medical Center /ID# 167139
- Hiroshima University Hospital /ID# 166006
- Asahikawa Medical University Hospital /ID# 167133
- Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 165943
- Sapporo Medical University Hospital /ID# 167137
- Aoyama Clinic /ID# 166001
- Hyogo College of Medicine College Hospital /Id# 200173
- Kanazawa University Hospital /ID# 169215
- Iwate Medical University Uchimaru Medical Center /ID# 202407
- Imamura General Hospital /ID# 227136
- Idzuro Imamura Hospital /ID# 206651
- Sameshima Hospital /ID# 206674
- Japanese Red Cross Kyoto Daiichi Hosital /ID# 165958
- Kyoto University Hospital /ID# 169888
- Yokkaichi Hazu Medical Center /ID# 167191
- Tohoku University Hospital /ID# 167135
- Nara Medical University Hospital /ID# 169216
- Kenseikai Dongo Hospital /ID# 208103
- Niigata University Medical & Dental Hospital /ID# 170044
- Ishida Clinic of IBD and Gastroenterology /ID# 167134
- Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 166002
- Okayama University Hospital /ID# 167355
- Kinshukai Infusion Clinic /ID# 218871
- Osaka City University Hospital /ID# 166007
- Osaka University Hospital /ID# 169662
- Osaka Medical and Pharmaceutical University Hospital /ID# 206324
- Tokitokai Tokito clinic /ID# 165945
- Shiga University of Medical Science Hospital /ID# 167141
- NHO Shizuoka Medical Center /ID# 167138
- Tokyo Medical And Dental University, Medical Hospital /ID# 165948
- Duplicate_Tokai University Hachioji Hospital /ID# 165951
- The Jikei University Hospital /ID# 167142
- Kyorin University Hospital /ID# 165950
- Tokyo Women's Medical University Hospital /ID# 205981
- Toyama Prefectural Central Hospital /ID# 217833
- Japanese Red Cross Wakayama Medical Center /ID# 200638
- Wakayama Medical University Hospital /ID# 169481
- Yamagata University Hospital /ID# 200156
- Hayang University GuriHospital /ID# 167578
- CHA University Bundang Medical Center /ID# 167583
- Kangbuk Samsung Hospital /ID# 167577
- Yonsei University Health System Severance Hospital /ID# 167581
- Inje University Haeundae Hospital /ID# 202629
- Dong-A University Hospital /ID# 167582
- Pusan National University Hospital /ID# 167580
- Kyungpook National Univ Hosp /ID# 207015
- Samsung Medical Center /ID# 167579
- Chung-Ang University Hostipal /ID# 207017
- Pauls Stradins Clinical University Hospital /ID# 169493
- Digestive Disease Center Gastro /ID# 169517
- Riga East Clinical University Hospital /ID# 169496
- Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 207263
- Vilnius University Hospital Santaros Klinikos /ID# 203285
- Hospital Sultanah Bahiyah /ID# 202627
- Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 170778
- Instituto de Investigaciones Aplicadas a la Neurociencias A.C. /ID# 207143
- Morales Vargas Centro de Investigacion S.C. /ID# 203495
- Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 206779
- Radboud Universitair Medisch Centrum /ID# 166925
- Zuyderland Medisch Centrum /ID# 169698
- Academisch Medisch Centrum /ID# 166924
- Medisch Spectrum Twente /ID# 170297
- Vistamed /ID# 208570
- Malopolskie Centrum Kliniczne /ID# 202166
- WIP Warsaw IBD Point Profesor Kierkus /ID# 224300
- Centrum Medyczne Reuma Park w Warszawie /ID# 200488
- Centrum Zdrowia MDM /ID# 200486
- Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 170225
- Hospital Egas Moniz /ID# 170249
- Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 200606
- Hospital Garcia de Orta, EPE /ID# 170234
- Centro Hospitalar Universitario de Sao Joao, EPE /ID# 170231
- Mindful Medical Research /ID# 203357
- School of Medicine University of Puerto Rico-Medical Science Campus /ID# 166770
- Institutul Clinic Fundeni /ID# 167826
- Clinica GASTRO MED SRL /ID# 206367
- Cabinet Particular Policlinic Algomed /ID# 167827
- Immanuel Kant Baltic Federal University /ID# 202128
- LLC Medical Center /ID# 209233
- Perm Clinical Center of the Federal Medical and Biological Agency /ID# 202988
- LLC Novaya Klinika /ID# 206615
- Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 202995
- Kazan State Medical University /ID# 169574
- Olla-Med Clinic /ID# 208721
- P.A. Bayandin Murmansk Regiona /ID# 169575
- Republican hospital named after V.A. Baranov /ID# 206487
- Euromedservice /ID# 206609
- X7 Clinical Research Center /ID# 216349
- City Clinical Hospital No. 31 /ID# 208870
- Clinical Hosp Center Zvezdara /ID# 168221
- Military Medical Academy /ID# 168784
- University Clinical Center Serbia /ID# 168220
- Clin Hosp Ctr Bezanijska Kosa /ID# 168799
- University Clinical Center Kragujevac /ID# 205858
- Clinical Center Vojvodina /ID# 168222
- KL Ling Gastroenterology and Liver Clinic /ID# 217963
- Gleneagles Medical Centre /ID# 206530
- Tan Tock Seng Hospital /ID# 203159
- Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 169952
- KM Management, spol. s.r.o. /ID# 170199
- Univ Medical Ctr Ljubljana /ID# 211042
- Farmovs (Pty) Ltd /Id# 207536
- Lenasia Clinical Trial Centre /ID# 205144
- Wits Clinical Research Site /ID# 170851
- Dr JP Wright /ID# 170885
- Private Practice Dr MN Rajabally /ID# 169852
- Hospital Unversitario Marques de Valdecilla /ID# 202039
- Hospital Universitari Son Espases /ID# 201997
- Hospital Universitario Dr. Negrin /ID# 171238
- Complejo Hospitalario de Navarra /ID# 202038
- Hospital Universitario A Coruna - CHUAC /ID# 203908
- Hospital Universitario Vall d'Hebron /ID# 171237
- Hospital Clinic de Barcelona /ID# 171242
- Hospital Universitario de Girona Doctor Josep Trueta /ID# 202040
- Hospital Juan Ramon Jimenez /ID# 171243
- Hospital Universitario La Paz /ID# 171241
- Hospital Universitario Virgen Macarena /ID# 171240
- Hospital Universitario y Politecnico La Fe /ID# 201988
- Hallands Hospital Halmstad /ID# 170840
- Alingsas lasarett /ID# 170838
- Sodra Alvsborgs sjukhus /ID# 202889
- Sahlgrenska University Hospital /ID# 169031
- Universitätsspital Zürich /ID# 170999
- Inselspital, Universitätsspital Bern /ID# 171006
- National Taiwan University Hospital /ID# 169789
- Linkou Chang Gung Memorial Ho /ID# 169788
- Acibadem Kozyatagi Hospital /ID# 209405
- Erciyes University Medical Fac /ID# 171321
- Ankara Univ Medical Faculty /ID# 206412
- Inonu Universitesi Turgut Ozal /ID# 201267
- Mustafa Kemal University Medic /ID# 171318
- Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 200280
- Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171316
- Mersin University Medical /ID# 171320
- Sisli Etfal Train & Res Hosp /ID# 171317
- Gazi Universitesi Tip Fakultes /ID# 217443
- South Eastern Health and Social Care Trust /ID# 205322
- Warrington and Halton Hospitals NHS Foundation Trust /ID# 171388
- Warrington and Halton Hospitals NHS Foundation Trust /ID# 209085
- Barts Health NHS Trust /ID# 218829
- Royal United Hospitals Bath /ID# 169084
- University Hospitals Birmingham NHS Foundation Trust /ID# 169080
- The Dudley Group NHS Foundation Trust /ID# 169079
- London North West University Healthcare NHS Trust /ID# 169078
- King's College Hospital NHS Foundation Trusts /ID# 169082
- The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 169085
- Stockport NHS foundation trust /ID# 208718
- Taunton and Somerset NHS Foundation Trust /ID# 209664
- St George's University Hospitals NHS Foundation Trust /ID# 205551
- The Royal Wolverhampton NHS Trust /ID# 171387
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Part 1 (Double-blind): Placebo
Part 1 (Double-blind): Upadacitinib 45 mg
Part 2 (Open-label): Upadacitinib 45 mg
Part 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB Placebo
Part 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mg
Part 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mg
Participants received upadacitinib matching placebo tablets, orally, once daily (QD) for 12 weeks during the Double-blind (DB) Induction Period.
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the DB Induction Period.
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the Open-label (OL) Induction Period.
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment (ET) Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received DB upadacitinib 45 mg in Part 1 and did not achieve clinical response at Week 12 were included in this group.
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received OL upadacitinib 45 mg during Part 2 and did not achieve clinical response at Week 12 were included in this group.