438
Participants
Start Date
February 6, 2019
Primary Completion Date
February 6, 2024
Study Completion Date
February 24, 2025
Upadacitinib
Administered orally once a day
Corticosteroid (CS)
At Baseline, all participants switched to corticosteroids (CS) provided by the sponsor with the oral prednisone or prednisolone dose at 20, 30, 40, 50, or 60 mg QD. The initial dose of prednisone or prednisolone was at the discretion of the investigator, based on disease severity and comorbid medical conditions, at a minimum of 20 mg QD at Baseline. At Baseline, if a participant was on a dose other than 20, 30, 40, 50, or 60 mg QD, the dose was rounded up or down, as clinically indicated per investigator discretion, to the nearest of these doses. Prednisone or prednisolone was tapered according to a predefined schedule over a 26- or 52-week period. Open-label prednisone or prednisolone was provided until the dose was tapered to 20 mg/day. Subsequently, blinded prednisone or prednisolone was provided for the remaining blinded taper regimen through Week 52.
Placebo
Administered orally once a day
Optimal Clinical Trials Ltd /ID# 201946, Grafotn
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 204018, Budapest
Orszagos Reumatologiai es Fizioterapias Intezet /ID# 211454, Budapest
Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 201781, Vienna
Del-Budai Centrumkorhaz Szent Imre Egyetemi Oktatokorhaz /ID# 201838, Budapest
HFR Fribourg - Hôpital cantonal /ID# 201114, Fribourg
Emeritus Research Sydney /ID# 201937, Botany
Aotearoa Clinical Trials /ID# 201942, Papatoetoe
Prince of Wales Hospital /ID# 210995, Randwick
Universitair Ziekenhuis Leuven /ID# 202779, Leuven
Drammen Sykehus /ID# 201560, Drammen
Inselspital, Universitaetsspital Bern /ID# 201364, Bern
Emeritus Research /ID# 201938, Camberwell
Waikato Hospital /ID# 201944, Hamilton
Universitätsspital Basel /ID# 201767, Basel Town
Debreceni Egyetem-Klinikai Kozpont /ID# 201526, Debrecen
Griffith University /ID# 223829, Southport
The Queen Elizabeth Hospital /ID# 201939, Woodville South
Haukeland universitetssjukehus /ID# 201602, Bergen
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 224334, Yvoir
Medizinische Universitaet Innsbruck /ID# 201786, Innsbruck
Fiona Stanley Hospital /ID# 201941, Murdoch
Sydvestjysk Sygehus /ID# 200216, Esbjerg
Porter Rheumatology Ltd /ID# 223830, Nelson
Timaru Medical Specialists Ltd /ID# 201943, Timaru
Aarhus University Hospital /ID# 171177, Aarhus C
CGM Research Trust /ID# 224061, Christchurch Central
UZ Gent /ID# 202778, Ghent
Kantonsspital St. Gallen /ID# 201134, Sankt Gallen
General Hospital of Athens Gennimatas /ID# 210129, Athens
General Hospital of Athens Ippokratio /ID# 202181, Athens
Hopital Saint Joseph /ID# 171540, Marseille
Immanuel Krankenhaus Berlin /ID# 223855, Buch
CHU de CAEN - Hopital de la Cote de Nacre /ID# 171539, Caen
University of Rochester Medical Center /ID# 213527, Rochester
Complejo Hospitalario Universitario A Coruña /ID# 224731, A Coruña
Hospital Universitario Virgen de las Nieves /ID# 224726, Granada
The Center for Rheumatology and Bone Research /ID# 168652, Wheaton
CHU Dijon /ID# 225277, Dijon
Carilion Clinic /ID# 212928, Roanoke
Hospital General Universitario Gregorio Maranon /ID# 201326, Madrid
Hospital Clinico San Carlos /ID# 204871, Madrid
Hospital Universitario La Paz /ID# 241848, Madrid
Hopital de la Cavale Blanche /ID# 171549, Brest
Piedmont Arthritis Clinic, PA /ID# 212431, Greenville
Arthritis and Rheumatology /ID# 170295, Atlanta
Medizinische Hochschule Hannover /ID# 200632, Hanover
CHU Toulouse - Hopital Purpan /ID# 171547, Toulouse
Omega Research Group /ID# 201903, Orlando
Lakes Research, LLC /ID# 210442, Miami
Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 200082, Udine
Ctr Arthritis & Rheumatic Dise /ID# 168667, Miami
IRIS Research and Development, LLC /ID# 169406, Plantation
Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 169040, Boca Raton
Medallion Clinical Research Institute, LLC /ID# 168666, Naples
Lovelace Scientific Resources /ID# 169041, Venice
The Lady Davis Carmel Medical Center /ID# 240731, Haifa
Rheum Assoc of North Alabama /ID# 168668, Huntsville
Hospital Meixoeiro (CHUVI) /ID# 212084, Vigo
CHRU Tours - Hopital Trousseau /ID# 245232, Chambray-lès-Tours
Arthritis Associates of Kingsport /ID# 212756, Kingsport
West Tennessee Research Institute /ID# 209256, Jackson
Hospital Universitario Canarias /ID# 224928, San Cristóbal de La Laguna
Hospital Universitario Marques de Valdecilla /ID# 201604, Santander
Azienda Sanitaria dell'Alto Adige /ID# 200081, Bolzano
Azienda Ospedaliero-Universitaria di Modena /ID# 200079, Modena
CHU de Nantes, Hotel Dieu -HME /ID# 171544, Nantes
Hospital Universitario Basurto /ID# 224730, Bilbao
Duplicate_AA Medical Research Center - Grand Blanc /ID# 201854, Grand Blanc
Duplicate_West Michigan Rheumatology /ID# 168647, Grand Rapids
Aurora Rheumatology and Immunotherapy Center /ID# 201853, Franklin
424 General MILITARY Hospital /ID# 210973, Efkarpia (Thessalonikis)
CHRU Lille - Hopital Claude Huriez /ID# 171543, Lille
Duplicate_Rush University Medical Center /ID# 224581, Chicago
Clinvest Research LLC /ID# 208182, Springfield
Physician Research Collaboration, LLC /ID# 168610, Lincoln
HCL - Hopital de la Croix-Rousse /ID# 211184, Lyon
Ochsner Clinic Foundation-New Orleans /ID# 171200, New Orleans
Louisiana State Univ HSC /ID# 202646, Shreveport
The Arthritis & Diabetes Clinic, Inc. /ID# 171199, Monroe
Universitaetsklinikum Tuebingen /ID# 223854, Tübingen
Medius Klinik Kirchheim /ID# 200637, Kirchheim unter Teck
Allen Arthritis /ID# 225527, Allen
Hopital Pitie Salpetriere /ID# 171542, Paris
Uppsala University Hospital /ID# 171403, Uppsala
Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 171545, Paris
Precision Comprehensive Clinical Research Solutions /ID# 201798, Colleyville
Baylor Scott & White Center for Diagnostic Medicine /ID# 213529, Temple
Tekton Research, L.L.C /ID# 201801, Austin
West Texas Clinical Research /ID# 204834, Lubbock
Denver Arthritis Clinic /ID# 171552, Denver
Institute of Arthritis Research /ID# 168490, Idaho Falls
Medizinische Versorgungszentren Burghausen Altoetting /ID# 208773, Burghausen
Robin K. Dore MD, Inc /ID# 201950, Tustin
Universitaetsklinikum Wuerzburg /ID# 213340, Würzburg
University of Washington /ID# 201619, Seattle
Kadlec Clinic Rheumatology /ID# 201618, Kennewick
Practicheskaya Medicina Clinic /ID# 224612, Moscow
First Moscow State Medical University n.a I.M. Sechenov /ID# 203673, Moscow
Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 221643, Moscow
Clinical Rheumatologic Hospital No 25 /ID# 208950, Saint Petersburg
Euromedservice /ID# 205345, Pushkin
Cabinet Medical Dr. Avram S.R.L /ID# 224336, Timișoara
Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 204887, Cluj-Napoca
Kemerovo State Medical University /ID# 203676, Kemerovo
Bnai Zion Medical Center /ID# 240733, Haifa
The Chaim Sheba Medical Center /ID# 241041, Ramat Gan
Tohoku University Hospital /ID# 200172, Sendai
Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 204702, Glendale
VA Long Beach Healthcare System /ID# 203833, Long Beach
Duplicate_Western Connecticut Health Network- Germantown Rd /ID# 205071, Danbury
Clinical Research of West Florida - Tampa /ID# 201899, Tampa
Clinical Research of West Florida, Inc /ID# 201901, Tampa
Duplicate_University of South Florida /ID# 207077, Tampa
Ochsner Clinic Foundation /ID# 200723, Baton Rouge
Rheumatology Associates PA - Portland /ID# 225011, Portland
University of Michigan Hospitals /ID# 168645, Ann Arbor
Wayne State University Health Center /ID# 212755, Detroit
Henry Ford Medical Center - New Center One /ID# 207456, Detroit
University Clinical Research Center /ID# 202504, Somerset
Marietta Memorial Hospital /ID# 210834, Marietta
STAT Research, Inc. /ID# 200436, Vandalia
University of Pennsylvania /ID# 168655, Philadelphia
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 212761, Summerville
Arthritis and Rheumatology Institute, PLLC /ID# 214612, Plano
University of Vermont Medical Center /ID# 211179, Burlington
Froedtert Memorial Lutheran Hospital /ID# 224557, Milwaukee
Duplicate_University of Alberta Hospital - Division of Hematology /ID# 208629, Edmonton
St. Joseph's Healthcare /ID# 204160, Hamilton
CISSSBSL -Hopital regional de Rimouski /ID# 224266, Rimouski
Centre de Recherche Musculo-Squelettique /ID# 201224, Trois-Rivières
Rheumatology Associates /ID# 201843, Saskatoon
Fakultni nemocnice Olomouc /ID# 202041, Olomouc
Axon Clinical, s.r.o. /ID# 202468, Prague
Medical Plus, s.r.o. /ID# 200865, Uherské Hradiště
Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 202946, Nagoya
Kagawa University Hospital /ID# 200171, Kita-gun
St. Marianna University Hospital /ID# 218692, Kawasaki-shi
Duplicate_Japanese Red Cross Kumamoto Hospital /ID# 203507, Kumamoto
Okayama University Hospital /ID# 203156, Okayama
Tomishiro Central Hospital /ID# 203897, Tomigusuku-shi
Sakai City Medical Center /ID# 202643, Sakai-shi
Duplicate_Jichi Medical University Hosp /ID# 200169, Shimotsuke-shi
St.Luke's International Hospital /ID# 200170, Chuo-ku
Radboud Universitair Medisch Centrum /ID# 212925, Nijmegen
Zuyderland Medisch Centrum /ID# 224551, Heerlen
ZiekenhuisGroep Twente /ID# 200038, Almelo
Medisch Centrum Leeuwarden /ID# 201716, Leeuwarden
Duplicate_Erasmus Medisch Centrum /ID# 201717, Rotterdam
Universitair Medisch Centrum Groningen /ID# 201715, Groningen
Rikshospitalet OUS HF /ID# 202004, Oslo
Unidade Local de Saude de Gaia/Espinho, EPE /ID# 208151, Vila Nova de Gaia
Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 205186, Ponte de Lima
Unidade Local de Saúde da Guarda, EPE /ID# 224878, Guarda
Unidade Local de Saude de Santa Maria, EPE /ID# 203530, Lisbon
Spitalul Clinic Sf. Maria /ID# 203809, Bucharest
Spitalul Clinic Colentina /ID# 204889, Bucharest
Hospital Clinic de Barcelona /ID# 201878, Barcelona
Skane University hospital /ID# 171407, Malmo
Karolinska University Hospital Solna /ID# 204945, Solna
Sahlgrenska Universitetssjukhuset /ID# 171405, Gothenburg
Duplicate_Danderyds sjukhus /ID# 171404, Stockholm
Duplicate_Vastmanlands Sjukhus /ID# 171429, Västerås
Royal United Hospitals Bath /ID# 239850, Bath
Royal Devon & Exeter Hospital /ID# 202834, Exeter
University Hospitals Dorset NHS Foundation Trust /ID# 202836, Poole
Barts Health NHS Trust /ID# 210511, London
UH Coventry & Warwickshire /ID# 202838, Coventry
Liverpool University University Hospitals NHS Foundation Trust /ID# 240391, Liverpool
Portsmouth Hospitals University NHS Trust /ID# 225002, Portsmouth
Southend Hospital /ID# 202839, Southend
Torbay and South Devon Nhs Foundation Trust /Id# 224689, Torquay
Lead Sponsor
AbbVie
INDUSTRY