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
3 other identifiers
interventional
429
23 countries
166
Brief 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, 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2019
Longer than P75 for phase_3
166 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2018
CompletedFirst Posted
Study publicly available on registry
October 30, 2018
CompletedStudy Start
First participant enrolled
January 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2024
CompletedResults Posted
Study results publicly available
March 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2025
CompletedFebruary 24, 2026
February 1, 2026
5 years
October 27, 2018
January 30, 2025
February 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
Percentage of Participants Achieving Sustained Complete Remission From Week 12 Through Week 52
Week 12 through Week 52
Cumulative Corticosteroid (CS) Exposure Through Week 52
Baseline up to Week 52
Time to First Disease Flare Through Week 52
Baseline up to Week 52
Percentage of Participants Who Experience at Least 1 Disease Flare Through Week 52
Baseline up to Week 52
Percentage of Participants in Complete Remission at Week 52
At Week 52
- +6 more secondary outcomes
Study Arms (8)
Placebo + 52-week CS taper
PLACEBO COMPARATORParticipants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
7.5 mg Upadacitinib + 26-week CS taper
EXPERIMENTALParticipants 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.
15 mg Upadacitinib + 26-week CS taper
EXPERIMENTALParticipants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
Placebo + 52-week CS taper -> Placebo
PLACEBO COMPARATORParticipants 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.
7.5 mg Upadacitinib + 26-week CS taper -> 7.5 mg Upadacitinib
EXPERIMENTALParticipants received 7.5 mg upadacitinib tablets administered orally once daily (QD) in Period 2.
7.5 mg Upadacitinib + 26-week CS taper -> Placebo
EXPERIMENTALParticipants received placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.
15 mg Upadacitinib + 26-week CS taper -> 15 mg Upadacitinib
EXPERIMENTALParticipants received 15 mg upadacitinib tablets administered orally once daily (QD) in Period 2.
15 mg Upadacitinib + 26-week CS taper -> Placebo
EXPERIMENTALParticipants received placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.
Interventions
Administered orally once a day
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.
Administered orally once a day
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (172)
Rheum Assoc of North Alabama /ID# 168668
Huntsville, Alabama, 35801, United States
Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 204702
Glendale, Arizona, 85306-9802, United States
VA Long Beach Healthcare System /ID# 203833
Long Beach, California, 90822-5201, United States
Robin K. Dore MD, Inc /ID# 201950
Tustin, California, 92780, United States
Denver Arthritis Clinic /ID# 171552
Denver, Colorado, 80230, United States
Duplicate_Western Connecticut Health Network- Germantown Rd /ID# 205071
Danbury, Connecticut, 06810-5038, United States
Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 169040
Boca Raton, Florida, 33486, United States
Lakes Research, LLC /ID# 210442
Miami, Florida, 33014, United States
Ctr Arthritis & Rheumatic Dise /ID# 168667
Miami, Florida, 33173, United States
Medallion Clinical Research Institute, LLC /ID# 168666
Naples, Florida, 34102, United States
Omega Research Group /ID# 201903
Orlando, Florida, 32808, United States
IRIS Research and Development, LLC /ID# 169406
Plantation, Florida, 33324, United States
Clinical Research of West Florida - Tampa /ID# 201899
Tampa, Florida, 33606-1246, United States
Clinical Research of West Florida, Inc /ID# 201901
Tampa, Florida, 33606-1246, United States
Duplicate_University of South Florida /ID# 207077
Tampa, Florida, 33612-2201, United States
Lovelace Scientific Resources /ID# 169041
Venice, Florida, 34292, United States
Arthritis and Rheumatology /ID# 170295
Atlanta, Georgia, 30342, United States
Institute of Arthritis Research /ID# 168490
Idaho Falls, Idaho, 83404, United States
Duplicate_Rush University Medical Center /ID# 224581
Chicago, Illinois, 60612, United States
Ochsner Clinic Foundation /ID# 200723
Baton Rouge, Louisiana, 70836-6455, United States
The Arthritis & Diabetes Clinic, Inc. /ID# 171199
Monroe, Louisiana, 71203, United States
Ochsner Clinic Foundation-New Orleans /ID# 171200
New Orleans, Louisiana, 70121, United States
Louisiana State Univ HSC /ID# 202646
Shreveport, Louisiana, 71130, United States
Rheumatology Associates PA - Portland /ID# 225011
Portland, Maine, 04102-2643, United States
The Center for Rheumatology and Bone Research /ID# 168652
Wheaton, Maryland, 20902, United States
University of Michigan Hospitals /ID# 168645
Ann Arbor, Michigan, 48109-5008, United States
Wayne State University Health Center /ID# 212755
Detroit, Michigan, 48201-2153, United States
Henry Ford Medical Center - New Center One /ID# 207456
Detroit, Michigan, 48202-3046, United States
Duplicate_AA Medical Research Center - Grand Blanc /ID# 201854
Grand Blanc, Michigan, 48439, United States
Duplicate_West Michigan Rheumatology /ID# 168647
Grand Rapids, Michigan, 49546, United States
Clinvest Research LLC /ID# 208182
Springfield, Missouri, 65807, United States
Physician Research Collaboration, LLC /ID# 168610
Lincoln, Nebraska, 68516, United States
University Clinical Research Center /ID# 202504
Somerset, New Jersey, 08873-3448, United States
University of Rochester Medical Center /ID# 213527
Rochester, New York, 14642, United States
Marietta Memorial Hospital /ID# 210834
Marietta, Ohio, 45750-1635, United States
STAT Research, Inc. /ID# 200436
Vandalia, Ohio, 45377-9464, United States
University of Pennsylvania /ID# 168655
Philadelphia, Pennsylvania, 19104-5502, United States
Piedmont Arthritis Clinic, PA /ID# 212431
Greenville, South Carolina, 29601, United States
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 212761
Summerville, South Carolina, 29486-7887, United States
West Tennessee Research Institute /ID# 209256
Jackson, Tennessee, 38305, United States
Arthritis Associates of Kingsport /ID# 212756
Kingsport, Tennessee, 37660, United States
Allen Arthritis /ID# 225527
Allen, Texas, 75013, United States
Tekton Research, L.L.C /ID# 201801
Austin, Texas, 78745, United States
Precision Comprehensive Clinical Research Solutions /ID# 201798
Colleyville, Texas, 76034, United States
West Texas Clinical Research /ID# 204834
Lubbock, Texas, 79424, United States
Arthritis and Rheumatology Institute, PLLC /ID# 214612
Plano, Texas, 75093-6419, United States
Baylor Scott & White Center for Diagnostic Medicine /ID# 213529
Temple, Texas, 76508, United States
University of Vermont Medical Center /ID# 211179
Burlington, Vermont, 05401-1473, United States
Carilion Clinic /ID# 212928
Roanoke, Virginia, 24016, United States
Kadlec Clinic Rheumatology /ID# 201618
Kennewick, Washington, 99336, United States
University of Washington /ID# 201619
Seattle, Washington, 98109, United States
Aurora Rheumatology and Immunotherapy Center /ID# 201853
Franklin, Wisconsin, 53132, United States
Froedtert Memorial Lutheran Hospital /ID# 224557
Milwaukee, Wisconsin, 53226-3522, United States
Emeritus Research Sydney /ID# 201937
Botany, New South Wales, 2019, Australia
Prince of Wales Hospital /ID# 210995
Randwick, New South Wales, 2031, Australia
Griffith University /ID# 223829
Southport, Queensland, 4222, Australia
The Queen Elizabeth Hospital /ID# 201939
Woodville South, South Australia, 5011, Australia
Emeritus Research /ID# 201938
Camberwell, Victoria, 3124, Australia
Fiona Stanley Hospital /ID# 201941
Murdoch, Western Australia, 6150, Australia
Medizinische Universitaet Innsbruck /ID# 201786
Innsbruck, Tyrol, 6020, Austria
Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 201781
Vienna, Vienna, 1100, Austria
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 224334
Yvoir, Namur, 5530, Belgium
UZ Gent /ID# 202778
Ghent, Oost-Vlaanderen, 9000, Belgium
Universitair Ziekenhuis Leuven /ID# 202779
Leuven, Vlaams-Brabant, 3000, Belgium
Duplicate_University of Alberta Hospital - Division of Hematology /ID# 208629
Edmonton, Alberta, T6G 2B7, Canada
St. Joseph's Healthcare /ID# 204160
Hamilton, Ontario, L8N 4A6, Canada
CISSSBSL -Hopital regional de Rimouski /ID# 224266
Rimouski, Quebec, G5L 5T1, Canada
Centre de Recherche Musculo-Squelettique /ID# 201224
Trois-Rivières, Quebec, G8Z 1Y2, Canada
Rheumatology Associates /ID# 201843
Saskatoon, Saskatchewan, S7K 0H6, Canada
Fakultni nemocnice Olomouc /ID# 202041
Olomouc, 779 00, Czechia
Axon Clinical, s.r.o. /ID# 202468
Prague, 140 00, Czechia
Medical Plus, s.r.o. /ID# 200865
Uherské Hradiště, 686 01, Czechia
Aarhus University Hospital /ID# 171177
Aarhus C, Central Jutland, 8000, Denmark
Sydvestjysk Sygehus /ID# 200216
Esbjerg, Region Syddanmark, 6700, Denmark
Hopital Saint Joseph /ID# 171540
Marseille, Bouches-du-Rhone, 13008, France
CHU Dijon /ID# 225277
Dijon, Cote-d Or, 21000, France
Hopital de la Cavale Blanche /ID# 171549
Brest, Finistere, 29200, France
CHU Toulouse - Hopital Purpan /ID# 171547
Toulouse, Haute-Garonne, 31059, France
CHRU Lille - Hopital Claude Huriez /ID# 171543
Lille, Nord, 59037, France
Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 171545
Paris, Paris, 75679, France
CHU de Nantes, Hotel Dieu -HME /ID# 171544
Nantes, Pays de la Loire Region, 44000, France
HCL - Hopital de la Croix-Rousse /ID# 211184
Lyon, Rhone, 69004, France
CHU de CAEN - Hopital de la Cote de Nacre /ID# 171539
Caen, 14033, France
CHRU Tours - Hopital Trousseau /ID# 245232
Chambray-lès-Tours, 37170, France
Hopital Pitie Salpetriere /ID# 171542
Paris, Île-de-France Region, 75013, France
Medius Klinik Kirchheim /ID# 200637
Kirchheim unter Teck, Baden-Wurttemberg, 73230, Germany
Universitaetsklinikum Tuebingen /ID# 223854
Tübingen, Baden-Wurttemberg, 72076, Germany
Universitaetsklinikum Wuerzburg /ID# 213340
Würzburg, Bavaria, 97080, Germany
Immanuel Krankenhaus Berlin /ID# 223855
Buch, 13125, Germany
Medizinische Versorgungszentren Burghausen Altoetting /ID# 208773
Burghausen, 84489, Germany
Medizinische Hochschule Hannover /ID# 200632
Hanover, 30625, Germany
General Hospital of Athens Gennimatas /ID# 210129
Athens, Attica, 11527, Greece
General Hospital of Athens Ippokratio /ID# 202181
Athens, Attica, 11527, Greece
424 General MILITARY Hospital /ID# 210973
Efkarpia (Thessalonikis), Thessaloniki, 56429, Greece
Debreceni Egyetem-Klinikai Kozpont /ID# 201526
Debrecen, Hajdú-Bihar, 4032, Hungary
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 204018
Budapest, 1023, Hungary
Orszagos Reumatologiai es Fizioterapias Intezet /ID# 211454
Budapest, 1023, Hungary
Del-Budai Centrumkorhaz Szent Imre Egyetemi Oktatokorhaz /ID# 201838
Budapest, 1115, Hungary
Bnai Zion Medical Center /ID# 240733
Haifa, H_efa, 3339419, Israel
The Lady Davis Carmel Medical Center /ID# 240731
Haifa, H_efa, 34362, Israel
The Chaim Sheba Medical Center /ID# 241041
Ramat Gan, Tel Aviv, 5265601, Israel
Azienda Sanitaria dell'Alto Adige /ID# 200081
Bolzano, 39100, Italy
Azienda Ospedaliero-Universitaria di Modena /ID# 200079
Modena, 41124, Italy
Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 200082
Udine, 33100, Italy
Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 202946
Nagoya, Aichi-ken, 455-8530, Japan
Kagawa University Hospital /ID# 200171
Kita-gun, Kagawa-ken, 761-0793, Japan
St. Marianna University Hospital /ID# 218692
Kawasaki-shi, Kanagawa, 216-8511, Japan
Duplicate_Japanese Red Cross Kumamoto Hospital /ID# 203507
Kumamoto, Kumamoto, 861-8520, Japan
Tohoku University Hospital /ID# 200172
Sendai, Miyagi, 9808574, Japan
Okayama University Hospital /ID# 203156
Okayama, Okayama-ken, 700-8558, Japan
Tomishiro Central Hospital /ID# 203897
Tomigusuku-shi, Okinawa, 901-0243, Japan
Sakai City Medical Center /ID# 202643
Sakai-shi, Osaka, 593-8304, Japan
Duplicate_Jichi Medical University Hosp /ID# 200169
Shimotsuke-shi, Tochigi, 329-0431, Japan
St.Luke's International Hospital /ID# 200170
Chuo-ku, Tokyo, 104-8560, Japan
Radboud Universitair Medisch Centrum /ID# 212925
Nijmegen, Gelderland, 6525 GA, Netherlands
Zuyderland Medisch Centrum /ID# 224551
Heerlen, Limburg, 6419 PC, Netherlands
ZiekenhuisGroep Twente /ID# 200038
Almelo, Overijssel, 7609 PP, Netherlands
Medisch Centrum Leeuwarden /ID# 201716
Leeuwarden, Provincie Friesland, 8934 AD, Netherlands
Duplicate_Erasmus Medisch Centrum /ID# 201717
Rotterdam, South Holland, 3015 GD, Netherlands
Universitair Medisch Centrum Groningen /ID# 201715
Groningen, 9713 GZ, Netherlands
Optimal Clinical Trials Ltd /ID# 201946
Grafotn, Auckland, 1010, New Zealand
Aotearoa Clinical Trials /ID# 201942
Papatoetoe, Auckland, 2025, New Zealand
Timaru Medical Specialists Ltd /ID# 201943
Timaru, Canterbury, 7910, New Zealand
Waikato Hospital /ID# 201944
Hamilton, Waikato Region, 3240, New Zealand
CGM Research Trust /ID# 224061
Christchurch Central, 8011, New Zealand
Porter Rheumatology Ltd /ID# 223830
Nelson, 7010, New Zealand
Drammen Sykehus /ID# 201560
Drammen, Buskerud, 3004, Norway
Haukeland universitetssjukehus /ID# 201602
Bergen, Hordaland, 5021, Norway
Rikshospitalet OUS HF /ID# 202004
Oslo, 0450, Norway
Unidade Local de Saude de Gaia/Espinho, EPE /ID# 208151
Vila Nova de Gaia, Porto District, 4434-502, Portugal
Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 205186
Ponte de Lima, Viana do Castelo District, 4990-041, Portugal
Unidade Local de Saúde da Guarda, EPE /ID# 224878
Guarda, 6300-035, Portugal
Unidade Local de Saude de Santa Maria, EPE /ID# 203530
Lisbon, 1649-035, Portugal
Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 204887
Cluj-Napoca, Cluj, 400006, Romania
Cabinet Medical Dr. Avram S.R.L /ID# 224336
Timișoara, Timiș County, 300134, Romania
Spitalul Clinic Sf. Maria /ID# 203809
Bucharest, 011172, Romania
Spitalul Clinic Colentina /ID# 204889
Bucharest, 020121, Romania
Kemerovo State Medical University /ID# 203676
Kemerovo, Kemerovo Oblast, 650056, Russia
Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 221643
Moscow, Moscow Oblast, 129110, Russia
Practicheskaya Medicina Clinic /ID# 224612
Moscow, 115372, Russia
First Moscow State Medical University n.a I.M. Sechenov /ID# 203673
Moscow, 119992, Russia
Euromedservice /ID# 205345
Pushkin, 196603, Russia
Clinical Rheumatologic Hospital No 25 /ID# 208950
Saint Petersburg, 190068, Russia
Complejo Hospitalario Universitario A Coruña /ID# 224731
A Coruña, A Coruna, 15006, Spain
Hospital Universitario Marques de Valdecilla /ID# 201604
Santander, Cantabria, 39008, Spain
Hospital Meixoeiro (CHUVI) /ID# 212084
Vigo, Pontevedra, 36213, Spain
Hospital Universitario Canarias /ID# 224928
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain
Hospital Universitario Basurto /ID# 224730
Bilbao, Vizcaya, 48013, Spain
Hospital Clinic de Barcelona /ID# 201878
Barcelona, 08036, Spain
Hospital Universitario Virgen de las Nieves /ID# 224726
Granada, 18014, Spain
Hospital General Universitario Gregorio Maranon /ID# 201326
Madrid, 28007, Spain
Hospital Clinico San Carlos /ID# 204871
Madrid, 28040, Spain
Hospital Universitario La Paz /ID# 241848
Madrid, 28046, Spain
Skane University hospital /ID# 171407
Malmo, Skåne County, 214 28, Sweden
Karolinska University Hospital Solna /ID# 204945
Solna, Stockholm County, 171 64, Sweden
Uppsala University Hospital /ID# 171403
Uppsala, Uppsala County, 75185, Sweden
Sahlgrenska Universitetssjukhuset /ID# 171405
Gothenburg, Västra Götaland County, 413 46, Sweden
Duplicate_Danderyds sjukhus /ID# 171404
Stockholm, 182 88, Sweden
Duplicate_Vastmanlands Sjukhus /ID# 171429
Västerås, 723 35, Sweden
Universitätsspital Basel /ID# 201767
Basel Town, Canton of Basel-City, 4031, Switzerland
Kantonsspital St. Gallen /ID# 201134
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
Inselspital, Universitaetsspital Bern /ID# 201364
Bern, 3010, Switzerland
HFR Fribourg - Hôpital cantonal /ID# 201114
Fribourg, 1708, Switzerland
Royal United Hospitals Bath /ID# 239850
Bath, Bath And North East Somerset, BA1 3NG, United Kingdom
Royal Devon & Exeter Hospital /ID# 202834
Exeter, Devon, EX2 5DW, United Kingdom
University Hospitals Dorset NHS Foundation Trust /ID# 202836
Poole, Dorset, BH15 2JB, United Kingdom
Barts Health NHS Trust /ID# 210511
London, Greater London, E1 2ES, United Kingdom
UH Coventry & Warwickshire /ID# 202838
Coventry, Warwickshire, CV2 2DX, United Kingdom
Liverpool University University Hospitals NHS Foundation Trust /ID# 240391
Liverpool, L9 7AL, United Kingdom
Portsmouth Hospitals University NHS Trust /ID# 225002
Portsmouth, PO6 3LY, United Kingdom
Southend Hospital /ID# 202839
Southend, SS0 0RY, United Kingdom
Torbay and South Devon Nhs Foundation Trust /Id# 224689
Torquay, TQ2 7AA, United Kingdom
Related Publications (2)
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.
PMID: 40174237DERIVEDLoricera 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.
PMID: 38840219DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2018
First Posted
October 30, 2018
Study Start
January 24, 2019
Primary Completion
February 6, 2024
Study Completion
March 11, 2025
Last Updated
February 24, 2026
Results First Posted
March 7, 2025
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- 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/
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.