Giant Cell Arteritis (GCA)Phase 3SELECT-GCANCT03725202
A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis
A Phase 3 study testing Upadacitinib and Corticosteroid (CS) in people with Giant Cell Arteritis (GCA), run by AbbVie at 172 sites in 24 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Giant Cell Arteritis (GCA)
- What is being tested?
- Upadacitinib and Corticosteroid (CS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 429 participants
- Where
- 172 sitesin 24 countries
- Study dates
- 24 Jan 2019to 11 Mar 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
172 sites in 24 countries.
172 sites in 24 countries
United States53 sites
Allen Arthritis /ID# 225527
Allen, Texas, 75013
University of Michigan Hospitals /ID# 168645
Ann Arbor, Michigan, 48109-5008
Arthritis and Rheumatology /ID# 170295
Atlanta, Georgia, 30342
Tekton Research, L.L.C /ID# 201801
Austin, Texas, 78745
Ochsner Clinic Foundation /ID# 200723
Baton Rouge, Louisiana, 70836-6455
Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 169040
Boca Raton, Florida, 33486
University of Vermont Medical Center /ID# 211179
Burlington, Vermont, 05401-1473
Duplicate_Rush University Medical Center /ID# 224581
Chicago, Illinois, 60612
Precision Comprehensive Clinical Research Solutions /ID# 201798
Colleyville, Texas, 76034
Duplicate_Western Connecticut Health Network- Germantown Rd /ID# 205071
Danbury, Connecticut, 06810-5038
Denver Arthritis Clinic /ID# 171552
Denver, Colorado, 80230
Wayne State University Health Center /ID# 212755
Detroit, Michigan, 48201-2153
Henry Ford Medical Center - New Center One /ID# 207456
Detroit, Michigan, 48202-3046
Aurora Rheumatology and Immunotherapy Center /ID# 201853
Franklin, Wisconsin, 53132
Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 204702
Glendale, Arizona, 85306-9802
Duplicate_AA Medical Research Center - Grand Blanc /ID# 201854
Grand Blanc, Michigan, 48439
Duplicate_West Michigan Rheumatology /ID# 168647
Grand Rapids, Michigan, 49546
Piedmont Arthritis Clinic, PA /ID# 212431
Greenville, South Carolina, 29601
Rheum Assoc of North Alabama /ID# 168668
Huntsville, Alabama, 35801
Institute of Arthritis Research /ID# 168490
Idaho Falls, Idaho, 83404
West Tennessee Research Institute /ID# 209256
Jackson, Tennessee, 38305
Kadlec Clinic Rheumatology /ID# 201618
Kennewick, Washington, 99336
Arthritis Associates of Kingsport /ID# 212756
Kingsport, Tennessee, 37660
Physician Research Collaboration, LLC /ID# 168610
Lincoln, Nebraska, 68516
VA Long Beach Healthcare System /ID# 203833
Long Beach, California, 90822-5201
West Texas Clinical Research /ID# 204834
Lubbock, Texas, 79424
Marietta Memorial Hospital /ID# 210834
Marietta, Ohio, 45750-1635
Lakes Research, LLC /ID# 210442
Miami, Florida, 33014
Ctr Arthritis & Rheumatic Dise /ID# 168667
Miami, Florida, 33173
Froedtert Memorial Lutheran Hospital /ID# 224557
Milwaukee, Wisconsin, 53226-3522
The Arthritis & Diabetes Clinic, Inc. /ID# 171199
Monroe, Louisiana, 71203
Medallion Clinical Research Institute, LLC /ID# 168666
Naples, Florida, 34102
Ochsner Clinic Foundation-New Orleans /ID# 171200
New Orleans, Louisiana, 70121
Omega Research Group /ID# 201903
Orlando, Florida, 32808
University of Pennsylvania /ID# 168655
Philadelphia, Pennsylvania, 19104-5502
Arthritis and Rheumatology Institute, PLLC /ID# 214612
Plano, Texas, 75093-6419
IRIS Research and Development, LLC /ID# 169406
Plantation, Florida, 33324
Rheumatology Associates PA - Portland /ID# 225011
Portland, Maine, 04102-2643
Carilion Clinic /ID# 212928
Roanoke, Virginia, 24016
University of Rochester Medical Center /ID# 213527
Rochester, New York, 14642
University of Washington /ID# 201619
Seattle, Washington, 98109
Louisiana State Univ HSC /ID# 202646
Shreveport, Louisiana, 71130
University Clinical Research Center /ID# 202504
Somerset, New Jersey, 08873-3448
Clinvest Research LLC /ID# 208182
Springfield, Missouri, 65807
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 212761
Summerville, South Carolina, 29486-7887
Clinical Research of West Florida - Tampa /ID# 201899
Tampa, Florida, 33606-1246
Clinical Research of West Florida, Inc /ID# 201901
Tampa, Florida, 33606-1246
Duplicate_University of South Florida /ID# 207077
Tampa, Florida, 33612-2201
Baylor Scott & White Center for Diagnostic Medicine /ID# 213529
Temple, Texas, 76508
Robin K. Dore MD, Inc /ID# 201950
Tustin, California, 92780
STAT Research, Inc. /ID# 200436
Vandalia, Ohio, 45377-9464
Lovelace Scientific Resources /ID# 169041
Venice, Florida, 34292
The Center for Rheumatology and Bone Research /ID# 168652
Wheaton, Maryland, 20902
France11 sites
Hopital de la Cavale Blanche /ID# 171549
Brest, Finistere, 29200
CHU de CAEN - Hopital de la Cote de Nacre /ID# 171539
Caen, 14033
CHRU Tours - Hopital Trousseau /ID# 245232
Chambray-lès-Tours, 37170
CHU Dijon /ID# 225277
Dijon, Cote-d Or, 21000
CHRU Lille - Hopital Claude Huriez /ID# 171543
Lille, Nord, 59037
HCL - Hopital de la Croix-Rousse /ID# 211184
Lyon, Rhone, 69004
Hopital Saint Joseph /ID# 171540
Marseille, Bouches-du-Rhone, 13008
CHU de Nantes, Hotel Dieu -HME /ID# 171544
Nantes, Pays de la Loire Region, 44000
Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 171545
Paris, Paris, 75679
Hopital Pitie Salpetriere /ID# 171542
Paris, Île-de-France Region, 75013
CHU Toulouse - Hopital Purpan /ID# 171547
Toulouse, Haute-Garonne, 31059
Japan10 sites
St.Luke's International Hospital /ID# 200170
Chuo-ku, Tokyo, 104-8560
St. Marianna University Hospital /ID# 218692
Kawasaki-shi, Kanagawa, 216-8511
Kagawa University Hospital /ID# 200171
Kita-gun, Kagawa-ken, 761-0793
Duplicate_Japanese Red Cross Kumamoto Hospital /ID# 203507
Kumamoto, Kumamoto, 861-8520
Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 202946
Nagoya, Aichi-ken, 455-8530
Okayama University Hospital /ID# 203156
Okayama, Okayama-ken, 700-8558
Sakai City Medical Center /ID# 202643
Sakai-shi, Osaka, 593-8304
Tohoku University Hospital /ID# 200172
Sendai, Miyagi, 9808574
Duplicate_Jichi Medical University Hosp /ID# 200169
Shimotsuke-shi, Tochigi, 329-0431
Tomishiro Central Hospital /ID# 203897
Tomigusuku-shi, Okinawa, 901-0243
Spain10 sites
Complejo Hospitalario Universitario A Coruña /ID# 224731
A Coruña, A Coruna, 15006
Hospital Clinic de Barcelona /ID# 201878
Barcelona, 08036
Hospital Universitario Basurto /ID# 224730
Bilbao, Vizcaya, 48013
Hospital Universitario Virgen de las Nieves /ID# 224726
Granada, 18014
Hospital General Universitario Gregorio Maranon /ID# 201326
Madrid, 28007
Hospital Clinico San Carlos /ID# 204871
Madrid, 28040
Hospital Universitario La Paz /ID# 241848
Madrid, 28046
Hospital Universitario Canarias /ID# 224928
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
Hospital Universitario Marques de Valdecilla /ID# 201604
Santander, Cantabria, 39008
Hospital Meixoeiro (CHUVI) /ID# 212084
Vigo, Pontevedra, 36213
United Kingdom9 sites
Royal United Hospitals Bath /ID# 239850
Bath, Bath And North East Somerset, BA1 3NG
UH Coventry & Warwickshire /ID# 202838
Coventry, Warwickshire, CV2 2DX
Royal Devon & Exeter Hospital /ID# 202834
Exeter, Devon, EX2 5DW
Liverpool University University Hospitals NHS Foundation Trust /ID# 240391
Liverpool, L9 7AL
Barts Health NHS Trust /ID# 210511
London, Greater London, E1 2ES
University Hospitals Dorset NHS Foundation Trust /ID# 202836
Poole, Dorset, BH15 2JB
Portsmouth Hospitals University NHS Trust /ID# 225002
Portsmouth, PO6 3LY
Southend Hospital /ID# 202839
Southend, SS0 0RY
Torbay and South Devon Nhs Foundation Trust /Id# 224689
Torquay, TQ2 7AA
Australia6 sites
Emeritus Research Sydney /ID# 201937
Botany, New South Wales, 2019
Emeritus Research /ID# 201938
Camberwell, Victoria, 3124
Fiona Stanley Hospital /ID# 201941
Murdoch, Western Australia, 6150
Prince of Wales Hospital /ID# 210995
Randwick, New South Wales, 2031
Griffith University /ID# 223829
Southport, Queensland, 4222
The Queen Elizabeth Hospital /ID# 201939
Woodville South, South Australia, 5011
Germany6 sites
Immanuel Krankenhaus Berlin /ID# 223855
Buch, 13125
Medizinische Versorgungszentren Burghausen Altoetting /ID# 208773
Burghausen, 84489
Medizinische Hochschule Hannover /ID# 200632
Hanover, 30625
Medius Klinik Kirchheim /ID# 200637
Kirchheim unter Teck, Baden-Wurttemberg, 73230
Universitaetsklinikum Tuebingen /ID# 223854
Tübingen, Baden-Wurttemberg, 72076
Universitaetsklinikum Wuerzburg /ID# 213340
Würzburg, Bavaria, 97080
Netherlands6 sites
ZiekenhuisGroep Twente /ID# 200038
Almelo, Overijssel, 7609 PP
Universitair Medisch Centrum Groningen /ID# 201715
Groningen, 9713 GZ
Zuyderland Medisch Centrum /ID# 224551
Heerlen, Limburg, 6419 PC
Medisch Centrum Leeuwarden /ID# 201716
Leeuwarden, Provincie Friesland, 8934 AD
Radboud Universitair Medisch Centrum /ID# 212925
Nijmegen, Gelderland, 6525 GA
Duplicate_Erasmus Medisch Centrum /ID# 201717
Rotterdam, South Holland, 3015 GD
New Zealand6 sites
CGM Research Trust /ID# 224061
Christchurch Central, 8011
Optimal Clinical Trials Ltd /ID# 201946
Grafotn, Auckland, 1010
Waikato Hospital /ID# 201944
Hamilton, Waikato Region, 3240
Porter Rheumatology Ltd /ID# 223830
Nelson, 7010
Aotearoa Clinical Trials /ID# 201942
Papatoetoe, Auckland, 2025
Timaru Medical Specialists Ltd /ID# 201943
Timaru, Canterbury, 7910
Russia6 sites
Kemerovo State Medical University /ID# 203676
Kemerovo, Kemerovo Oblast, 650056
Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 221643
Moscow, Moscow Oblast, 129110
Practicheskaya Medicina Clinic /ID# 224612
Moscow, 115372
First Moscow State Medical University n.a I.M. Sechenov /ID# 203673
Moscow, 119992
Euromedservice /ID# 205345
Pushkin, 196603
Clinical Rheumatologic Hospital No 25 /ID# 208950
Saint Petersburg, 190068
Sweden6 sites
Sahlgrenska Universitetssjukhuset /ID# 171405
Gothenburg, Västra Götaland County, 413 46
Skane University hospital /ID# 171407
Malmö, Skåne County, 214 28
Karolinska University Hospital Solna /ID# 204945
Solna, Stockholm County, 171 64
Duplicate_Danderyds sjukhus /ID# 171404
Stockholm, 182 88
Uppsala University Hospital /ID# 171403
Uppsala, Uppsala County, 75185
Duplicate_Vastmanlands Sjukhus /ID# 171429
Västerås, 723 35
Canada5 sites
Duplicate_University of Alberta Hospital - Division of Hematology /ID# 208629
Edmonton, Alberta, T6G 2B7
St. Joseph's Healthcare /ID# 204160
Hamilton, Ontario, L8N 4A6
CISSSBSL -Hopital regional de Rimouski /ID# 224266
Rimouski, Quebec, G5L 5T1
Rheumatology Associates /ID# 201843
Saskatoon, Saskatchewan, S7K 0H6
Centre de Recherche Musculo-Squelettique /ID# 201224
Trois-Rivières, Quebec, G8Z 1Y2
Hungary4 sites
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 204018
Budapest, 1023
Orszagos Reumatologiai es Fizioterapias Intezet /ID# 211454
Budapest, 1023
Del-Budai Centrumkorhaz Szent Imre Egyetemi Oktatokorhaz /ID# 201838
Budapest, 1115
Debreceni Egyetem-Klinikai Kozpont /ID# 201526
Debrecen, Hajdú-Bihar, 4032
Portugal4 sites
Unidade Local de Saúde da Guarda, EPE /ID# 224878
Guarda, 6300-035
Unidade Local de Saude de Santa Maria, EPE /ID# 203530
Lisbon, 1649-035
Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 205186
Ponte de Lima, Viana do Castelo District, 4990-041
Unidade Local de Saude de Gaia/Espinho, EPE /ID# 208151
Vila Nova de Gaia, Porto District, 4434-502
Romania4 sites
Spitalul Clinic Sf. Maria /ID# 203809
Bucharest, 011172
Spitalul Clinic Colentina /ID# 204889
Bucharest, 020121
Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 204887
Cluj-Napoca, Cluj, 400006
Cabinet Medical Dr. Avram S.R.L /ID# 224336
Timișoara, Timiș County, 300134
Switzerland4 sites
Universitätsspital Basel /ID# 201767
Basel Town, Canton of Basel-City, 4031
Inselspital, Universitaetsspital Bern /ID# 201364
Bern, 3010
HFR Fribourg - Hôpital cantonal /ID# 201114
Fribourg, 1708
Kantonsspital St. Gallen /ID# 201134
Sankt Gallen, Canton of St. Gallen, 9007
Belgium3 sites
UZ Gent /ID# 202778
Ghent, Oost-Vlaanderen, 9000
Universitair Ziekenhuis Leuven /ID# 202779
Leuven, Vlaams-Brabant, 3000
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 224334
Yvoir, Namur, 5530
Czechia3 sites
Fakultni nemocnice Olomouc /ID# 202041
Olomouc, 779 00
Axon Clinical, s.r.o. /ID# 202468
Prague, 140 00
Medical Plus, s.r.o. /ID# 200865
Uherské Hradiště, 686 01
Greece3 sites
General Hospital of Athens Gennimatas /ID# 210129
Athens, Attica, 11527
General Hospital of Athens Ippokratio /ID# 202181
Athens, Attica, 11527
424 General MILITARY Hospital /ID# 210973
Efkarpia (Thessalonikis), Thessaloniki, 56429
Israel3 sites
Bnai Zion Medical Center /ID# 240733
Haifa, H_efa, 3339419
The Lady Davis Carmel Medical Center /ID# 240731
Haifa, H_efa, 34362
The Chaim Sheba Medical Center /ID# 241041
Ramat Gan, Tel Aviv, 5265601
Italy3 sites
Azienda Sanitaria dell'Alto Adige /ID# 200081
Bolzano, 39100
Azienda Ospedaliero-Universitaria di Modena /ID# 200079
Modena, 41124
Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 200082
Udine, 33100
Norway3 sites
Haukeland universitetssjukehus /ID# 201602
Bergen, Hordaland, 5021
Drammen Sykehus /ID# 201560
Drammen, Buskerud, 3004
Rikshospitalet OUS HF /ID# 202004
Oslo, 0450
Austria2 sites
Medizinische Universitaet Innsbruck /ID# 201786
Innsbruck, Tyrol, 6020
Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 201781
Vienna, State of Vienna, 1100
Denmark2 sites
Aarhus University Hospital /ID# 171177
Aarhus C, Central Jutland, 8000
Sydvestjysk Sygehus /ID# 200216
Esbjerg, Region Syddanmark, 6700
About this study
Official title: 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.
- Conditions
- Giant Cell Arteritis (GCA)
- Being tested
- Upadacitinib, Corticosteroid (CS), Placebo
- Keywords
- Giant Cell Arteritis (GCA), ABT-494, Upadacitinib
- Medical subject headings
- Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UpadacitinibDrug
Also called ABT-494, RINVOQ
Administered orally once a day
Corticosteroid (CS)Drug
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.
PlaceboOther
Administered orally once a day
| Study group | Role | What they receive |
|---|---|---|
| Placebo + 52-week CS taper | Placebo comparator | 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. Receives: Drug: Corticosteroid (CS); Other: Placebo |
| 7.5 mg Upadacitinib + 26-week CS taper | Experimental | 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. Receives: Drug: Upadacitinib; Drug: Corticosteroid (CS) |
| 15 mg Upadacitinib + 26-week CS taper | Experimental | 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. Receives: Drug: Upadacitinib; Drug: Corticosteroid (CS) |
| Placebo + 52-week CS taper -> Placebo | Placebo comparator | 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. Receives: Other: Placebo |
| 7.5 mg Upadacitinib + 26-week CS taper -> 7.5 mg Upadacitinib | Experimental | Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) in Period 2. Receives: Drug: Upadacitinib |
| 7.5 mg Upadacitinib + 26-week CS taper -> Placebo | Experimental | Participants received placebo tablets for upadacitinib administered orally once daily (QD) in Period 2. Receives: Other: Placebo |
| 15 mg Upadacitinib + 26-week CS taper -> 15 mg Upadacitinib | Experimental | Participants received 15 mg upadacitinib tablets administered orally once daily (QD) in Period 2. Receives: Drug: Upadacitinib |
| 15 mg Upadacitinib + 26-week CS taper -> Placebo | Experimental | Participants received placebo tablets for upadacitinib administered orally once daily (QD) in Period 2. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Week 12 to Week 52
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start24 Jan 2019
- Primary completion6 Feb 2024
- Study completion11 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Giant Cell Arteritis (GCA)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 429 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725202
- Sponsor's protocol ID
- M16-852
- Other IDs
- 2023-505476-29-00, 2017-003978-13, 2017, 2023
- Acronym
- SELECT-GCA
- Status last verified
- Feb 2026
- First submitted
- 27 Oct 2018
- Last updated
- 24 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 40174237Loricera 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.
PubMed 38840219