A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Giant Cell Arteritis: SELECT-GCA

This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen compared to placebo in combination with a 52-week CS taper regimen, as measured by the proportion of participants in sustained remission at Week 52, and to assess the safety and tolerability of upadacitinib in participants with giant cell arteritis (GCA). The objective of Period 2 is to evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved sustained remission in Period 1.

Study Overview

• Status: Completed
• Conditions: Giant Cell Arteritis (GCA)
• Intervention / Treatment: Drug: Corticosteroid (CS); Other: Placebo; Drug: Upadacitinib

• Study Type: Interventional
• Enrollment (Actual): 429
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Botany, New South Wales, Australia, 2019
      • Emeritus Research Sydney /ID# 201937
    • Randwick, New South Wales, Australia, 2031
      • Prince of Wales Hospital /ID# 210995
  • Queensland
    • Southport, Queensland, Australia, 4222
      • Griffith University /ID# 223829
  • South Australia
    • Woodville South, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital /ID# 201939
  • Victoria
    • Camberwell, Victoria, Australia, 3124
      • Emeritus Research /ID# 201938
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital /ID# 201941
• Austria
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Medizinische Universitaet Innsbruck /ID# 201786
  • Vienna
    • Vienna, Vienna, Austria, 1100
      • Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 201781
• Belgium
  • Namur
    • Yvoir, Namur, Belgium, 5530
      • Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 224334
  • Oost-Vlaanderen
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • UZ Gent /ID# 202778
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Universitair Ziekenhuis Leuven /ID# 202779
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • Duplicate_University of Alberta Hospital - Division of Hematology /ID# 208629
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare /ID# 204160
  • Quebec
    • Rimouski, Quebec, Canada, G5L 5T1
      • CISSSBSL -Hopital regional de Rimouski /ID# 224266
    • Trois-Rivières, Quebec, Canada, G8Z 1Y2
      • Centre de Recherche Musculo-Squelettique /ID# 201224
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 0H6
      • Rheumatology Associates /ID# 201843
• Czechia
  • Olomouc, Czechia, 779 00
    • Fakultni nemocnice Olomouc /ID# 202041
  • Prague, Czechia, 140 00
    • Axon Clinical, s.r.o. /ID# 202468
  • Uherské Hradiště, Czechia, 686 01
    • Medical Plus, s.r.o. /ID# 200865
• Denmark
  • Central Jutland
    • Aarhus C, Central Jutland, Denmark, 8000
      • Aarhus University Hospital /ID# 171177
  • Region Syddanmark
    • Esbjerg, Region Syddanmark, Denmark, 6700
      • Sydvestjysk Sygehus /ID# 200216
• France
  • Caen, France, 14033
    • CHU de CAEN - Hopital de la Cote de Nacre /ID# 171539
  • Chambray-lès-Tours, France, 37170
    • CHRU Tours - Hopital Trousseau /ID# 245232
  • Bouches-du-Rhone
    • Marseille, Bouches-du-Rhone, France, 13008
      • Hopital Saint Joseph /ID# 171540
  • Cote-d Or
    • Dijon, Cote-d Or, France, 21000
      • CHU Dijon /ID# 225277
  • Finistere
    • Brest, Finistere, France, 29200
      • Hopital de la Cavale Blanche /ID# 171549
  • Haute-Garonne
    • Toulouse, Haute-Garonne, France, 31059
      • CHU Toulouse - Hopital Purpan /ID# 171547
  • Nord
    • Lille, Nord, France, 59037
      • CHRU Lille - Hopital Claude Huriez /ID# 171543
  • Paris
    • Paris, Paris, France, 75679
      • Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 171545
  • Pays de la Loire Region
    • Nantes, Pays de la Loire Region, France, 44000
      • CHU de Nantes, Hotel Dieu -HME /ID# 171544
  • Rhone
    • Lyon, Rhone, France, 69004
      • HCL - Hopital de la Croix-Rousse /ID# 211184
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75013
      • Hopital Pitie Salpetriere /ID# 171542
• Germany
  • Buch, Germany, 13125
    • Immanuel Krankenhaus Berlin /ID# 223855
  • Burghausen, Germany, 84489
    • Medizinische Versorgungszentren Burghausen Altoetting /ID# 208773
  • Hanover, Germany, 30625
    • Medizinische Hochschule Hannover /ID# 200632
  • Baden-Wurttemberg
    • Kirchheim unter Teck, Baden-Wurttemberg, Germany, 73230
      • Medius Klinik Kirchheim /ID# 200637
    • Tübingen, Baden-Wurttemberg, Germany, 72076
      • Universitaetsklinikum Tuebingen /ID# 223854
  • Bavaria
    • Würzburg, Bavaria, Germany, 97080
      • Universitaetsklinikum Wuerzburg /ID# 213340
• Greece
  • Attica
    • Athens, Attica, Greece, 11527
      • General Hospital of Athens Gennimatas /ID# 210129
    • Athens, Attica, Greece, 11527
      • General Hospital of Athens Ippokratio /ID# 202181
  • Thessaloniki
    • Efkarpia (Thessalonikis), Thessaloniki, Greece, 56429
      • 424 General MILITARY Hospital /ID# 210973
• Hungary
  • Budapest, Hungary, 1023
    • Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 204018
  • Budapest, Hungary, 1023
    • Orszagos Reumatologiai es Fizioterapias Intezet /ID# 211454
  • Budapest, Hungary, 1115
    • Del-Budai Centrumkorhaz Szent Imre Egyetemi Oktatokorhaz /ID# 201838
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, 4032
      • Debreceni Egyetem-Klinikai Kozpont /ID# 201526
• Israel
  • H_efa
    • Haifa, H_efa, Israel, 3339419
      • Bnai Zion Medical Center /ID# 240733
    • Haifa, H_efa, Israel, 34362
      • The Lady Davis Carmel Medical Center /ID# 240731
  • Tel Aviv
    • Ramat Gan, Tel Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 241041
• Italy
  • Bolzano, Italy, 39100
    • Azienda Sanitaria dell'Alto Adige /ID# 200081
  • Modena, Italy, 41124
    • Azienda Ospedaliero-Universitaria di Modena /ID# 200079
  • Udine, Italy, 33100
    • Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 200082
• Japan
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 455-8530
      • Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 202946
  • Kagawa-ken
    • Kita-gun, Kagawa-ken, Japan, 761-0793
      • Kagawa University Hospital /ID# 200171
  • Kanagawa
    • Kawasaki-shi, Kanagawa, Japan, 216-8511
      • St. Marianna University Hospital /ID# 218692
  • Kumamoto
    • Kumamoto, Kumamoto, Japan, 861-8520
      • Duplicate_Japanese Red Cross Kumamoto Hospital /ID# 203507
  • Miyagi
    • Sendai, Miyagi, Japan, 9808574
      • Tohoku University Hospital /ID# 200172
  • Okayama-ken
    • Okayama, Okayama-ken, Japan, 700-8558
      • Okayama University Hospital /ID# 203156
  • Okinawa
    • Tomigusuku-shi, Okinawa, Japan, 901-0243
      • Tomishiro Central Hospital /ID# 203897
  • Osaka
    • Sakai-shi, Osaka, Japan, 593-8304
      • Sakai City Medical Center /ID# 202643
  • Tochigi
    • Shimotsuke-shi, Tochigi, Japan, 329-0431
      • Duplicate_Jichi Medical University Hosp /ID# 200169
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-8560
      • St.Luke's International Hospital /ID# 200170
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • Universitair Medisch Centrum Groningen /ID# 201715
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • Radboud Universitair Medisch Centrum /ID# 212925
  • Limburg
    • Heerlen, Limburg, Netherlands, 6419 PC
      • Zuyderland Medisch Centrum /ID# 224551
  • Overijssel
    • Almelo, Overijssel, Netherlands, 7609 PP
      • ZiekenhuisGroep Twente /ID# 200038
  • Provincie Friesland
    • Leeuwarden, Provincie Friesland, Netherlands, 8934 AD
      • Medisch Centrum Leeuwarden /ID# 201716
  • South Holland
    • Rotterdam, South Holland, Netherlands, 3015 GD
      • Duplicate_Erasmus Medisch Centrum /ID# 201717
• New Zealand
  • Christchurch Central, New Zealand, 8011
    • CGM Research Trust /ID# 224061
  • Nelson, New Zealand, 7010
    • Porter Rheumatology Ltd /ID# 223830
  • Auckland
    • Grafotn, Auckland, New Zealand, 1010
      • Optimal Clinical Trials Ltd /ID# 201946
    • Papatoetoe, Auckland, New Zealand, 2025
      • Aotearoa Clinical Trials /ID# 201942
  • Canterbury
    • Timaru, Canterbury, New Zealand, 7910
      • Timaru Medical Specialists Ltd /ID# 201943
  • Waikato Region
    • Hamilton, Waikato Region, New Zealand, 3240
      • Waikato Hospital /ID# 201944
• Norway
  • Oslo, Norway, 0450
    • Rikshospitalet OUS HF /ID# 202004
  • Buskerud
    • Drammen, Buskerud, Norway, 3004
      • Drammen Sykehus /ID# 201560
  • Hordaland
    • Bergen, Hordaland, Norway, 5021
      • Haukeland universitetssjukehus /ID# 201602
• Portugal
  • Guarda, Portugal, 6300-035
    • Unidade Local de Saúde da Guarda, EPE /ID# 224878
  • Lisbon, Portugal, 1649-035
    • Unidade Local de Saude de Santa Maria, EPE /ID# 203530
  • Porto District
    • Vila Nova de Gaia, Porto District, Portugal, 4434-502
      • Unidade Local de Saude de Gaia/Espinho, EPE /ID# 208151
  • Viana do Castelo District
    • Ponte de Lima, Viana do Castelo District, Portugal, 4990-041
      • Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 205186
• Romania
  • Bucharest, Romania, 011172
    • Spitalul Clinic Sf. Maria /ID# 203809
  • Bucharest, Romania, 020121
    • Spitalul Clinic Colentina /ID# 204889
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400006
      • Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 204887
  • Timiș County
    • Timișoara, Timiș County, Romania, 300134
      • Cabinet Medical Dr. Avram S.R.L /ID# 224336
• Russia
  • Moscow, Russia, 115372
    • Practicheskaya Medicina Clinic /ID# 224612
  • Moscow, Russia, 119992
    • First Moscow State Medical University n.a I.M. Sechenov /ID# 203673
  • Pushkin, Russia, 196603
    • Euromedservice /ID# 205345
  • Saint Petersburg, Russia, 190068
    • Clinical Rheumatologic Hospital No 25 /ID# 208950
  • Kemerovo Oblast
    • Kemerovo, Kemerovo Oblast, Russia, 650056
      • Kemerovo State Medical University /ID# 203676
  • Moscow Oblast
    • Moscow, Moscow Oblast, Russia, 129110
      • Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 221643
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona /ID# 201878
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de las Nieves /ID# 224726
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon /ID# 201326
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz /ID# 241848
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos /ID# 204871
  • A Coruna
    • A Coruña, A Coruna, Spain, 15006
      • Complejo Hospitalario Universitario A Coruña /ID# 224731
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marques de Valdecilla /ID# 201604
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36213
      • Hospital Meixoeiro (CHUVI) /ID# 212084
  • Santa Cruz De Tenerife
    • San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain, 38320
      • Hospital Universitario Canarias /ID# 224928
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013
      • Hospital Universitario Basurto /ID# 224730
• Sweden
  • Stockholm, Sweden, 182 88
    • Duplicate_Danderyds sjukhus /ID# 171404
  • Västerås, Sweden, 723 35
    • Duplicate_Vastmanlands Sjukhus /ID# 171429
  • Skåne County
    • Malmo, Skåne County, Sweden, 214 28
      • Skane University hospital /ID# 171407
  • Stockholm County
    • Solna, Stockholm County, Sweden, 171 64
      • Karolinska University Hospital Solna /ID# 204945
  • Uppsala County
    • Uppsala, Uppsala County, Sweden, 75185
      • Uppsala University Hospital /ID# 171403
  • Västra Götaland County
    • Gothenburg, Västra Götaland County, Sweden, 413 46
      • Sahlgrenska Universitetssjukhuset /ID# 171405
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital, Universitaetsspital Bern /ID# 201364
  • Fribourg, Switzerland, 1708
    • HFR Fribourg - Hôpital cantonal /ID# 201114
  • Canton of Basel-City
    • Basel Town, Canton of Basel-City, Switzerland, 4031
      • Universitätsspital Basel /ID# 201767
  • Canton of St. Gallen
    • Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
      • Kantonsspital St. Gallen /ID# 201134
• United Kingdom
  • Liverpool, United Kingdom, L9 7AL
    • Liverpool University University Hospitals NHS Foundation Trust /ID# 240391
  • Portsmouth, United Kingdom, PO6 3LY
    • Portsmouth Hospitals University NHS Trust /ID# 225002
  • Southend, United Kingdom, SS0 0RY
    • Southend Hospital /ID# 202839
  • Torquay, United Kingdom, TQ2 7AA
    • Torbay and South Devon Nhs Foundation Trust /Id# 224689
  • Bath And North East Somerset
    • Bath, Bath And North East Somerset, United Kingdom, BA1 3NG
      • Royal United Hospitals Bath /ID# 239850
  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
      • Royal Devon & Exeter Hospital /ID# 202834
  • Dorset
    • Poole, Dorset, United Kingdom, BH15 2JB
      • University Hospitals Dorset NHS Foundation Trust /ID# 202836
  • Greater London
    • London, Greater London, United Kingdom, E1 2ES
      • Barts Health NHS Trust /ID# 210511
  • Warwickshire
    • Coventry, Warwickshire, United Kingdom, CV2 2DX
      • UH Coventry & Warwickshire /ID# 202838
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Rheum Assoc of North Alabama /ID# 168668
  • Arizona
    • Glendale, Arizona, United States, 85306-9802
      • Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 204702
  • California
    • Long Beach, California, United States, 90822-5201
      • VA Long Beach Healthcare System /ID# 203833
    • Tustin, California, United States, 92780
      • Robin K. Dore MD, Inc /ID# 201950
  • Colorado
    • Denver, Colorado, United States, 80230
      • Denver Arthritis Clinic /ID# 171552
  • Connecticut
    • Danbury, Connecticut, United States, 06810-5038
      • Duplicate_Western Connecticut Health Network- Germantown Rd /ID# 205071
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 169040
    • Miami, Florida, United States, 33014
      • Lakes Research, LLC /ID# 210442
    • Miami, Florida, United States, 33173
      • Ctr Arthritis & Rheumatic Dise /ID# 168667
    • Naples, Florida, United States, 34102
      • Medallion Clinical Research Institute, LLC /ID# 168666
    • Orlando, Florida, United States, 32808
      • Omega Research Group /ID# 201903
    • Plantation, Florida, United States, 33324
      • IRIS Research and Development, LLC /ID# 169406
    • Tampa, Florida, United States, 33606-1246
      • Clinical Research of West Florida - Tampa /ID# 201899
    • Tampa, Florida, United States, 33606-1246
      • Clinical Research of West Florida, Inc /ID# 201901
    • Tampa, Florida, United States, 33612-2201
      • Duplicate_University of South Florida /ID# 207077
    • Venice, Florida, United States, 34292
      • Lovelace Scientific Resources /ID# 169041
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Arthritis and Rheumatology /ID# 170295
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Institute of Arthritis Research /ID# 168490
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Duplicate_Rush University Medical Center /ID# 224581
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70836-6455
      • Ochsner Clinic Foundation /ID# 200723
    • Monroe, Louisiana, United States, 71203
      • The Arthritis & Diabetes Clinic, Inc. /ID# 171199
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation-New Orleans /ID# 171200
    • Shreveport, Louisiana, United States, 71130
      • Louisiana State Univ HSC /ID# 202646
  • Maine
    • Portland, Maine, United States, 04102-2643
      • Rheumatology Associates PA - Portland /ID# 225011
  • Maryland
    • Wheaton, Maryland, United States, 20902
      • The Center for Rheumatology and Bone Research /ID# 168652
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5008
      • University of Michigan Hospitals /ID# 168645
    • Detroit, Michigan, United States, 48201-2153
      • Wayne State University Health Center /ID# 212755
    • Detroit, Michigan, United States, 48202-3046
      • Henry Ford Medical Center - New Center One /ID# 207456
    • Grand Blanc, Michigan, United States, 48439
      • Duplicate_AA Medical Research Center - Grand Blanc /ID# 201854
    • Grand Rapids, Michigan, United States, 49546
      • Duplicate_West Michigan Rheumatology /ID# 168647
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Clinvest Research LLC /ID# 208182
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Physician Research Collaboration, LLC /ID# 168610
  • New Jersey
    • Somerset, New Jersey, United States, 08873-3448
      • University Clinical Research Center /ID# 202504
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center /ID# 213527
  • Ohio
    • Marietta, Ohio, United States, 45750-1635
      • Marietta Memorial Hospital /ID# 210834
    • Vandalia, Ohio, United States, 45377-9464
      • STAT Research, Inc. /ID# 200436
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-5502
      • University of Pennsylvania /ID# 168655
  • South Carolina
    • Greenville, South Carolina, United States, 29601
      • Piedmont Arthritis Clinic, PA /ID# 212431
    • Summerville, South Carolina, United States, 29486-7887
      • Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 212761
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • West Tennessee Research Institute /ID# 209256
    • Kingsport, Tennessee, United States, 37660
      • Arthritis Associates of Kingsport /ID# 212756
  • Texas
    • Allen, Texas, United States, 75013
      • Allen Arthritis /ID# 225527
    • Austin, Texas, United States, 78745
      • Tekton Research, L.L.C /ID# 201801
    • Colleyville, Texas, United States, 76034
      • Precision Comprehensive Clinical Research Solutions /ID# 201798
    • Lubbock, Texas, United States, 79424
      • West Texas Clinical Research /ID# 204834
    • Plano, Texas, United States, 75093-6419
      • Arthritis and Rheumatology Institute, PLLC /ID# 214612
    • Temple, Texas, United States, 76508
      • Baylor Scott & White Center for Diagnostic Medicine /ID# 213529
  • Vermont
    • Burlington, Vermont, United States, 05401-1473
      • University of Vermont Medical Center /ID# 211179
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Carilion Clinic /ID# 212928
  • Washington
    • Kennewick, Washington, United States, 99336
      • Kadlec Clinic Rheumatology /ID# 201618
    • Seattle, Washington, United States, 98109
      • University of Washington /ID# 201619
  • Wisconsin
    • Franklin, Wisconsin, United States, 53132
      • Aurora Rheumatology and Immunotherapy Center /ID# 201853
    • Milwaukee, Wisconsin, United States, 53226-3522
      • Froedtert Memorial Lutheran Hospital /ID# 224557

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of giant cell arteritis (GCA) according to the following criteria:

  • History of erythrocyte sedimentation rate (ESR) >= 50 mm/hour or high sensitivity C-reactive protein (hsCRP)/CRP >=1.0 mg/dL
  • Presence of at least one of the following: Unequivocal cranial symptoms of GCA or Unequivocal symptoms of polymyalgia rheumatica (PMR)
  • Presence of at least one of the following: temporal artery biopsy revealing features of GCA or evidence of large vessel vasculitis by angiography or cross-sectional imaging such as ultrasound, magnetic resonance imaging (MRI), computed tomography (CT) or positron emission tomography (PET).
• Active GCA, either new onset or relapsing, within 8 weeks of Baseline.
• Participants must have received treatment with >=40 mg prednisone (or equivalent) at any time prior to Baseline and be receiving prednisone (or equivalent) >= 20 mg once daily (QD) at Baseline.
• Participants must have GCA that, in the opinion of the investigator, is clinically stable to allow the participant to safely initiate the protocol-defined corticosteroid (CS) taper regimen.
• Females must either be postmenopausal or permanently surgically sterile or, practicing at least 1 specified method of birth control through the study.

Exclusion Criteria:

• Prior exposure to any Janus Kinase (JAK) inhibitor.
• Treatment with an interleukin-6 (IL-6) inhibitor within 4 weeks of study start, or prior treatment with an IL-6 inhibitor and experienced a disease flare during treatment.

• Use of any of the following systemic immunosuppressant treatments within the specified timeframe prior to study start:

  • Anakinra within 1 week of study start.
  • Methotrexate, hydroxychloroquine, cyclosporine, azathioprine, or mycophenolate within 4 weeks of study start.
  • Oral corticosteroid (CS) for conditions other than GCA within 4 week of study start, or intravenous CS within 4 weeks of study start.
  • Greater than or equal to 8 weeks for leflunomide if no elimination procedure was followed, or adhere to an elimination procedure.
  • Cell-depleting agents or alkylating agents including cyclophosphamide within 6 months of study start.
• Current or past history of infection including herpes zoster or herpes simplex, human immunodeficiency virus (HIV), active Tuberculosis, active or chronic recurring infection, active hepatitis B or C.
• Female who is pregnant, breastfeeding, or considering pregnancy during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo + 52-week CS taper; Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.	Drug: 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.; Other: Placebo; Administered orally once a day
Experimental: 7.5 mg Upadacitinib + 26-week CS taper; Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.	Drug: 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.; Drug: Upadacitinib; Administered orally once a day; Other Names: RINVOQ; ABT-494
Experimental: 15 mg Upadacitinib + 26-week CS taper; Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.	Drug: 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.; Drug: Upadacitinib; Administered orally once a day; Other Names: RINVOQ; ABT-494
Placebo Comparator: Placebo + 52-week CS taper -> Placebo; Participants who achieved sustained remission for at least 24 weeks prior to the Week 52 visit (at the end of Period 1) OR at remission at the Week 52 visit only who were assigned to placebo tablets for upadacitinib administered orally once daily (QD) in Period 1 continued to receive placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.	Other: Placebo; Administered orally once a day
Experimental: 7.5 mg Upadacitinib + 26-week CS taper -> 7.5 mg Upadacitinib; Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) in Period 2.	Drug: Upadacitinib; Administered orally once a day; Other Names: RINVOQ; ABT-494
Experimental: 7.5 mg Upadacitinib + 26-week CS taper -> Placebo; Participants received placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.	Other: Placebo; Administered orally once a day
Experimental: 15 mg Upadacitinib + 26-week CS taper -> 15 mg Upadacitinib; Participants received 15 mg upadacitinib tablets administered orally once daily (QD) in Period 2.	Drug: Upadacitinib; Administered orally once a day; Other Names: RINVOQ; ABT-494
Experimental: 15 mg Upadacitinib + 26-week CS taper -> Placebo; Participants received placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.	Other: Placebo; Administered orally once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Sustained Remission at Week 52	Sustained remission is defined as having achieved absence of giant cell arteritis (GCA) signs and symptoms from Week 12 through Week 52, and adherence to the protocol-defined corticosteroid (CS) taper regimen.	From Week 12 to Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Sustained Complete Remission From Week 12 Through Week 52	Sustained complete remission is defined as having absence of giant cell arteritis (GCA) signs and symptoms from Week 12 through Week 52; normalization of erythrocyte sedimentation rate (ESR); normalization of high sensitivity C-reactive protein (hs-CRP) and adherence to the protocol-defined CS taper regimen.	Week 12 through Week 52
Cumulative Corticosteroid (CS) Exposure Through Week 52	The cumulative exposure to corticosteroid(s) through Week 52 of the study was documented.	Baseline up to Week 52
Time to First Disease Flare Through Week 52	Disease flare is defined as an event determined by the investigator to represent recurrence of Giant Cell Arteritis (GCA) signs or symptoms or an erythrocyte sedimentation rate (ESR) measurement > 30 mm/hr (attributable to GCA) AND requiring an increase in corticosteroid (CS) dose.	Baseline up to Week 52
Percentage of Participants Who Experience at Least 1 Disease Flare Through Week 52	The percentage of participants who experience at least 1 disease flare was calculated. Disease flare is defined as an event determined by the investigator to represent recurrence of Giant Cell Arteritis (GCA) signs or symptoms or an erythrocyte sedimentation rate (ESR) measurement > 30 mm/hr (attributable to GCA) AND requiring an increase in corticosteroid (CS) dose.	Baseline up to Week 52
Percentage of Participants in Complete Remission at Week 52	Complete remission is defined as having achieved absence of Giant Cell Arteritis (GCA) signs and symptoms; normalization of erythrocyte sedimentation rate (ESR) to < 30 mm/hr-- if ESR ≥30 mm/hr and elevation is not attributable to GCA, this criterion can still be met); normalization of high sensitivity C-reactive protein (hs-CRP) to < 1 mg/dL; and adherence to the protocol-defined corticosteroid (CS) taper regimen.	At Week 52
Percentage of Participants in Complete Remission at Week 24	Complete remission is defined as having achieved absence of Giant Cell Arteritis (GCA) signs and symptoms; normalization of erythrocyte sedimentation rate (ESR) to < 30 mm/hr-- if ESR ≥30 mm/hr and elevation is not attributable to GCA, this criterion can still be met); normalization of high sensitivity C-reactive protein (hs-CRP) to < 1 mg/dL; and adherence to the protocol-defined corticosteroid (CS) taper regimen.	At Week 24
Change From Baseline in the 36-item Short Form Quality of Life Questionnaire (SF-36) Physical Component Summary (PCS) Score at Week 52	The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical component summary (PCS) is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The SF-36 PCS ranges from 0 to 100. A linear algorithm was applied to the calculation of the PCS which has a normative mean value of 50. Higher scores are associated with less disability; a score of 100 is equivalent to no disability and a score of 0 is equivalent to maximum disability. A positive change from the Baseline score indicates improvement.	Baseline, Week 52
Number of Disease Flares Per Participant Through Week 52	The number of disease flares per participant during Period 1 was documented, and was adjusted by the duration of study participation.	Baseline up to Week 52
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) at Week 52	The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days, including physical fatigue, functional fatigue, emotional fatigue, and social consequences of fatigue. Participants respond to the questions on a scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue score is computed by summing the item scores, after reversing items worded in the negative direction. The FACIT-Fatigue score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement.	Baseline, Week 52
Assessment of Treatment Satisfaction Questionnaire for Medication (TSQM) Patient Global Satisfaction Subscale at Week 52	The Treatment Satisfaction Questionnaire for Medications (TSQM) is a generic ePRO measure of treatment satisfaction, developed to compare treatment satisfaction between medication types and conditions. TSQM comprises of 14 items to assess 4 domains (effectiveness, side effects, convenience, and global satisfaction). The TSQM items are rated on a Likert scale (1 = extremely dissatisfied to 7 = extremely satisfied). Scores for each of the 4 domains range from 0 to 100, with higher scores corresponding to higher satisfaction. A positive change from Baseline indicates improvement.	At Week 52
Rate of Corticosteroid-related Adverse Events Though Week 52	The rate of corticosteroid-related adverse events was calculated, and was adjusted by duration of study drug exposure.	Baseline up to Week 52

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

General Publications

• Blockmans D, Penn SK, Setty AR, Schmidt WA, Rubbert-Roth A, Hauge EM, Keen HI, Ishii T, Khalidi N, Dejaco C, Cid MC, Hellmich B, Liu M, Zhao W, Lagunes I, Romero AB, Wung PK, Merkel PA; SELECT-GCA Study Group. A Phase 3 Trial of Upadacitinib for Giant-Cell Arteritis. N Engl J Med. 2025 May 29;392(20):2013-2024. doi: 10.1056/NEJMoa2413449. Epub 2025 Apr 2.
• Loricera J, Tofade T, Prieto-Pena D, Romero-Yuste S, de Miguel E, Riveros-Frutos A, Ferraz-Amaro I, Labrador E, Maiz O, Becerra E, Narvaez J, Galindez-Agirregoikoa E, Gonzalez-Fernandez I, Urruticoechea-Arana A, Ramos-Calvo A, Lopez-Gutierrez F, Castaneda S, Unizony S, Blanco R. Effectiveness of janus kinase inhibitors in relapsing giant cell arteritis in real-world clinical practice and review of the literature. Arthritis Res Ther. 2024 Jun 5;26(1):116. doi: 10.1186/s13075-024-03314-9.

Helpful Links

• Description Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2019
• Primary Completion (Actual): February 6, 2024
• Study Completion (Actual): March 11, 2025

Study Registration Dates

• First Submitted: October 27, 2018
• First Submitted That Met QC Criteria: October 27, 2018
• First Posted (Actual): October 30, 2018

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Upadacitinib; ABT-494; Giant Cell Arteritis (GCA)
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Autoimmune Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Skin Diseases; Skin Diseases, Vascular; Vasculitis; Vasculitis, Central Nervous System; Arteritis; Skin and Connective Tissue Diseases; Giant Cell Arteritis; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; upadacitinib; Adrenal Cortex Hormones
• Other Study ID Numbers: M16-852; 2017-003978-13 (EudraCT Number); 2023-505476-29-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No