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 remission in Period 1.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 50 Years and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03725202 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
AbbVie |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
ABBVIE INC. |
Principal Investigator Affiliation | AbbVie |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Australia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Netherlands, New Zealand, Norway, Portugal, Romania, Russian Federation, Spain, Sweden, Switzerland, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Giant Cell Arteritis (GCA) |
Study Website: | View Trial Website |
Experimental: Arm A
Upadacitinib dose A administered daily + 26-week CS taper regimen
Experimental: Arm B
Upadacitinib dose B administered daily + 26-week CS taper regimen
Placebo Comparator: Arm C
Placebo administered daily + 52-week CS taper regimen
Drug: - Upadacitinib
It will be administered orally.
Drug: - Corticosteroid (CS)
It will be administered orally.
Other: - Placebo
It will be administered orally.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Completed
Address
Rheum Assoc of North Alabama /ID# 168668
Huntsville, Alabama, 35801
Status
Recruiting
Address
Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 204702
Glendale, Arizona, 85306-9802
Status
Completed
Address
VA Long Beach Healthcare System /ID# 203833
Long Beach, California, 90822-5201
Status
Recruiting
Address
Robin K. Dore MD, Inc /ID# 201950
Tustin, California, 92780
Status
Recruiting
Address
Denver Arthritis Clinic /ID# 171552
Denver, Colorado, 80230
Status
Completed
Address
Western Connecticut Health Network- Germantown Rd /ID# 205071
Danbury, Connecticut, 06810-5038
Status
Completed
Address
Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 169040
Boca Raton, Florida, 33486
Status
Completed
Address
Clinical Research of West Florida, Inc /ID# 201901
Clearwater, Florida, 33765
Status
Completed
Address
Lakes Research, LLC /ID# 210442
Miami, Florida, 33014
Status
Completed
Address
Ctr Arthritis & Rheumatic Dise /ID# 168667
Miami, Florida, 33173
Status
Completed
Address
Medallion Clinical Research Institute, LLC /ID# 168666
Naples, Florida, 34102
Status
Completed
Address
Omega Research Maitland, LLC /ID# 201903
Orlando, Florida, 32808
Status
Completed
Address
IRIS Research and Development, LLC /ID# 169406
Plantation, Florida, 33324
Status
Completed
Address
Clinical Research of West Florida - Tampa /ID# 201899
Tampa, Florida, 33606-1246
Status
Completed
Address
University of South Florida /ID# 207077
Tampa, Florida, 33612-2201
Status
Completed
Address
Lovelace Scientific Resources /ID# 169041
Venice, Florida, 34292
Status
Recruiting
Address
Arthritis and Rheumatology /ID# 170295
Atlanta, Georgia, 30342
Status
Completed
Address
Institute of Arthritis Research /ID# 168490
Idaho Falls, Idaho, 83404
Status
Recruiting
Address
Rush University Medical Center /ID# 224581
Chicago, Illinois, 60612
Status
Completed
Address
Ochsner Clinic Foundation /ID# 200723
Baton Rouge, Louisiana, 70836-6455
Status
Completed
Address
The Arthritis & Diabetes Clinic, Inc. /ID# 171199
Monroe, Louisiana, 71203
Status
Recruiting
Address
Ochsner Clinic Foundation-New Orleans /ID# 171200
New Orleans, Louisiana, 70121
Status
Recruiting
Address
Louisiana State Univ HSC /ID# 202646
Shreveport, Louisiana, 71130
Status
Recruiting
Address
Rheumatology Associates PA - Portland /ID# 225011
Portland, Maine, 04102-2643
Status
Completed
Address
The Center for Rheumatology and Bone Research /ID# 168652
Wheaton, Maryland, 20902
Status
Completed
Address
University of Michigan Hospitals /ID# 168645
Ann Arbor, Michigan, 48109-5008
Status
Recruiting
Address
Wayne State University Health Center /ID# 212755
Detroit, Michigan, 48201-2153
Status
Completed
Address
Henry Ford Medical Center /ID# 207456
Detroit, Michigan, 48202-3046
Status
Completed
Address
AA Medical Research Center - Grand Blanc /ID# 201854
Grand Blanc, Michigan, 48439
Status
Completed
Address
Duplicate_West Michigan Rheumatology /ID# 168647
Grand Rapids, Michigan, 49546
Status
Completed
Address
Clinvest Research LLC /ID# 208182
Springfield, Missouri, 65807
Status
Recruiting
Address
Physician Research Collaboration, LLC /ID# 168610
Lincoln, Nebraska, 68516
Status
Recruiting
Address
University Clinical Research Center /ID# 202504
Somerset, New Jersey, 08873-3448
Status
Recruiting
Address
University of Rochester Medical Center /ID# 213527
Rochester, New York, 14642
Status
Completed
Address
Marietta Memorial Hospital /ID# 210834
Marietta, Ohio, 45750-1635
Status
Completed
Address
STAT Research, Inc. /ID# 200436
Vandalia, Ohio, 45377-9464
Status
Recruiting
Address
University of Pennsylvania /ID# 168655
Philadelphia, Pennsylvania, 19104-5502
Status
Completed
Address
Piedmont Arthritis Clinic, PA /ID# 212431
Greenville, South Carolina, 29601
Status
Recruiting
Address
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 212761
Summerville, South Carolina, 29486-7887
Status
Recruiting
Address
West Tennessee Research Institute /ID# 209256
Jackson, Tennessee, 38305
Status
Completed
Address
Arthritis Associates of Kingsport /ID# 212756
Kingsport, Tennessee, 37660
Status
Recruiting
Address
Allen Arthritis /ID# 225527
Allen, Texas, 75013
Status
Completed
Address
Tekton Research, Inc. /ID# 201801
Austin, Texas, 78745
Status
Recruiting
Address
Precision Comprehensive Clinical Research Solutions /ID# 201798
Colleyville, Texas, 76034
Status
Completed
Address
West Texas Clinical Research /ID# 204834
Lubbock, Texas, 79424
Status
Recruiting
Address
Arthritis and Rheumatology Institute, PLLC /ID# 214612
Plano, Texas, 75093-6419
Status
Completed
Address
Baylor Scott & White Center for Diagnostic Medicine /ID# 213529
Temple, Texas, 76508
Status
Completed
Address
University of Vermont Medical Center /ID# 211179
Burlington, Vermont, 05401-1473
Status
Recruiting
Address
Carilion Clinic /ID# 212928
Roanoke, Virginia, 24016
Status
Completed
Address
Kadlec Clinic Rheumatology /ID# 201618
Kennewick, Washington, 99336
Status
Recruiting
Address
University of Washington /ID# 201619
Seattle, Washington, 98109
Status
Completed
Address
Aurora Rheumatology and Immunotherapy Center /ID# 201853
Franklin, Wisconsin, 53132
Status
Recruiting
Address
Froedtert Memorial Lutheran Hospital /ID# 224557
Milwaukee, Wisconsin, 53226-3522
Status
Recruiting
Address
Emeritus Research Sydney /ID# 201937
Botany, New South Wales, 2019
Status
Recruiting
Address
Prince of Wales Hospital /ID# 210995
Randwick, New South Wales, 2031
Status
Recruiting
Address
Griffith University /ID# 223829
Southport, Queensland, 4222
Status
Recruiting
Address
The Queen Elizabeth Hospital /ID# 201939
Woodville South, South Australia, 5011
Status
Recruiting
Address
Emeritus Research /ID# 201938
Camberwell, Victoria, 3124
Status
Recruiting
Address
Fiona Stanley Hospital /ID# 201941
Murdoch, Western Australia, 6150
Status
Completed
Address
Medizinische Universitaet Innsbruck /ID# 201786
Innsbruck, Tirol, 6020
Status
Recruiting
Address
Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 201781
Vienna, Wien, 1100
Status
Recruiting
Address
CHU UCL Namur - site Godinne /ID# 224334
Godinne, Namur, 5530
Status
Recruiting
Address
UZ Gent /ID# 202778
Gent, Oost-Vlaanderen, 9000
Status
Recruiting
Address
Universitair Ziekenhuis Leuven /ID# 202779
Leuven, Vlaams-Brabant, 3000
Status
Completed
Address
University of Alberta Hospital - Division of Hematology /ID# 208629
Edmonton, Alberta, T6G 2B7
Status
Recruiting
Address
St. Joseph's Healthcare /ID# 204160
Hamilton, Ontario, L8N 4A6
Status
Recruiting
Address
CISSSBSL -Hopital regional de Rimouski /ID# 224266
Rimouski, Quebec, G5L 5T1
Status
Recruiting
Address
Centre de Recherche Musculo-Squelettique /ID# 201224
Trois-rivières, Quebec, G8Z 1Y2
Status
Completed
Address
Rheumatology Associates /ID# 201843
Saskatoon, Saskatchewan, S7K 0H6
Status
Recruiting
Address
Fakultni nemocnice Olomouc /ID# 202041
Olomouc, , 779 00
Status
Completed
Address
Axon Clinical, s.r.o. /ID# 202468
Praha, , 140 00
Status
Recruiting
Address
MEDICAL PLUS, s.r.o. /ID# 200865
Uherske Hradiste, , 686 01
Status
Recruiting
Address
Aarhus University Hospital /ID# 171177
Aarhus C, Midtjylland, 8000
Status
Recruiting
Address
Sydvestjysk Sygehus /ID# 200216
Esbjerg, , 6700
Status
Recruiting
Address
Hopital Saint Joseph /ID# 171540
Marseille, Bouches-du-Rhone, 13008
Status
Recruiting
Address
CHU Dijon /ID# 225277
Dijon, Cote-d Or, 21000
Status
Recruiting
Address
CHU Toulouse - Hopital Purpan /ID# 171547
TOULOUSE Cedex 9, Haute-Garonne, 31059
Status
Recruiting
Address
CHRU Lille - Hopital Claude Huriez /ID# 171543
Lille, Hauts-de-France, 59037
Status
Recruiting
Address
CHU de Nantes, Hotel Dieu -HME /ID# 171544
Nantes, Pays-de-la-Loire, 44000
Status
Recruiting
Address
HCL - Hopital de la Croix-Rousse /ID# 211184
Lyon, Rhone, 69004
Status
Recruiting
Address
Hopital de la Cavale Blanche /ID# 171549
Brest, , 29200
Status
Recruiting
Address
CHU de CAEN - Hopital de la Cote de Nacre /ID# 171539
Caen, , 14033
Status
Recruiting
Address
CHRU Tours - Hopital Trousseau /ID# 245232
Chambray Les Tours, , 37170
Status
Recruiting
Address
Hopital Pitie Salpetriere /ID# 171542
Paris, , 75013
Status
Recruiting
Address
AP-HP - Hopital Cochin /ID# 171545
Paris, , 75014
Status
Recruiting
Address
Medius Klinik Kirchheim /ID# 200637
Kirchheim unter Teck, Baden-Wuerttemberg, 73230
Status
Recruiting
Address
Universitaetsklinikum Tuebingen /ID# 223854
Tubingen, Baden-Wuerttemberg, 72076
Status
Recruiting
Address
Immanuel Krankenhaus Berlin /ID# 223855
Berlin-buch, , 13125
Status
Recruiting
Address
Medizinische Versorgungszentren Burghausen Altoetting /ID# 208773
Burghausen, , 84489
Status
Recruiting
Address
Medizinische Hochschule Hannover /ID# 200632
Hannover, , 30625
Status
Recruiting
Address
Universitaetsklinikum Wuerzburg /ID# 213340
Wuerzburg, , 97080
Status
Active, not recruiting
Address
General Hospital of Athens Gennimatas /ID# 210129
Athens, Attiki, 11527
Status
Recruiting
Address
General Hospital of Athens Ippokratio /ID# 202181
Athens, Attiki, 11527
Status
Active, not recruiting
Address
424 General MILITARY Hospital /ID# 210973
Efkarpia (Thessalonikis), Thessaloniki, 56429
Status
Recruiting
Address
Debreceni Egyetem Klinikai Kozpont /ID# 201526
Debrecen, Hajdu-Bihar, 4032
Status
Completed
Address
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 204018
Budapest, , 1023
Status
Completed
Address
Orszagos Reumatologiai es Fizioterapias Intezet /ID# 211454
Budapest, , 1023
Status
Recruiting
Address
Szent Imre Egyetemi Oktatokorhaz /ID# 201838
Budapest, , 1115
Status
Recruiting
Address
The Chaim Sheba Medical Center /ID# 241041
Ramat Gan, Tel-Aviv, 5265601
Status
Recruiting
Address
Bnai Zion Medical Center /ID# 240733
Haifa, , 3339419
Status
Recruiting
Address
The Lady Davis Carmel Medical Center /ID# 240731
Haifa, , 34362
Status
Recruiting
Address
Azienda Sanitaria dell'Alto Adige/Ospedale di Bolzano /ID# 200081
Bolzano, , 39100
Status
Recruiting
Address
Azienda Ospedaliero-Universitaria di Modena /ID# 200079
Modena, , 41124
Status
Recruiting
Address
Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 200082
Udine, , 33100
Status
Recruiting
Address
Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 202946
Nagoya-shi, Aichi, 455-8530
Status
Recruiting
Address
Kagawa University Hospital /ID# 200171
Kita-gun, Kagawa, 761-0793
Status
Recruiting
Address
St. Marianna University Hospital /ID# 218692
Kawasaki-shi, Kanagawa, 216-8511
Status
Recruiting
Address
Japanese Red Cross Kumamoto Hospital /ID# 203507
Kumamoto-shi, Kumamoto, 861-8520
Status
Recruiting
Address
Tohoku University Hospital /ID# 200172
Sendai-shi, Miyagi, 9808574
Status
Recruiting
Address
Okayama University Hospital /ID# 203156
Okayama-shi, Okayama, 700-8558
Status
Completed
Address
Tomishiro Central Hospital /ID# 203897
Tomigusuku-shi, Okinawa, 901-0243
Status
Completed
Address
Sakai City Medical Center /ID# 202643
Sakai-shi, Osaka, 593-8304
Status
Completed
Address
Duplicate_Jichi Medical University Hosp /ID# 200169
Shimotsuke-shi, Tochigi, 329-0431
Status
Recruiting
Address
St.Luke's International Hospital /ID# 200170
Chuo-ku, Tokyo, 104-8560
Status
Recruiting
Address
Radboud Universitair Medisch Centrum /ID# 212925
Nijmegen, Gelderland, 6525 GA
Status
Recruiting
Address
Zuyderland Medisch Centrum /ID# 224551
Heerlen, Limburg, 6419 PC
Status
Recruiting
Address
Erasmus Medisch Centrum /ID# 201717
Rotterdam, Zuid-Holland, 3015 GD
Status
Recruiting
Address
ZiekenhuisGroep Twente /ID# 200038
Almelo, , 7609 PP
Status
Recruiting
Address
Universitair Medisch Centrum Groningen /ID# 201715
Groningen, , 9713 GZ
Status
Recruiting
Address
Medisch Centrum Leeuwarden /ID# 201716
Leeuwarden, , 8934 AD
Status
Recruiting
Address
Optimal Clinical Trials Ltd /ID# 201946
Grafotn, Auckland, 1010
Status
Recruiting
Address
Middlemore Clinical Trials /ID# 201942
Papatoetoe, Auckland, 2025
Status
Recruiting
Address
Timaru Medical Specialists Ltd /ID# 201943
Timaru, Canterbury, 7910
Status
Recruiting
Address
Waikato Hospital /ID# 201944
Hamilton, Waikato, 3240
Status
Recruiting
Address
CGM Research Trust /ID# 224061
Christchurch Central, , 8011
Status
Recruiting
Address
Porter Rheumatology Ltd /ID# 223830
Nelson, , 7010
Status
Recruiting
Address
Drammen Sykehus /ID# 201560
Drammen, Buskerud, 3004
Status
Completed
Address
Haukeland universitetssjukehus /ID# 201602
Bergen, Hordaland, 5021
Status
Completed
Address
Rikshospitalet OUS HF /ID# 202004
Oslo, , 0450
Status
Recruiting
Address
Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 208151
Vila Nova De Gaia, Porto, 4434-502
Status
Recruiting
Address
Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 205186
Ponte de Lima, Viana Do Castelo, 4990-041
Status
Recruiting
Address
Unidade Local de Saúde da Guarda, EPE /ID# 224878
Guarda, , 6300-035
Status
Recruiting
Address
Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 203530
Lisboa, , 1649-035
Status
Recruiting
Address
Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 204887
Cluj-Napoca, Cluj, 400006
Status
Recruiting
Address
Cabinet Medical Dr. Avram S.R.L /ID# 224336
Timisoara, Timis, 300134
Status
Recruiting
Address
Spitalul Clinic Sf. Maria /ID# 203809
Bucuresti, , 011172
Status
Recruiting
Address
Spitalul Clinic Colentina /ID# 204889
Bucuresti, , 020121
Status
Completed
Address
Kemerovo State Medical University /ID# 203676
Kemerovo, Kemerovskaya Oblast, 650056
Status
Active, not recruiting
Address
Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 221643
Moscow, Moskovskaya Oblast, 129110
Status
Active, not recruiting
Address
Practicheskaya Medicina Clinic /ID# 224612
Moscow, , 115372
Status
Completed
Address
First Moscow State Medical University n.a I.M. Sechenov /ID# 203673
Moscow, , 119992
Status
Active, not recruiting
Address
Euromedservice /ID# 205345
Pushkin, , 196603
Status
Active, not recruiting
Address
Clinical Rheumatologic Hospital No 25 /ID# 208950
St. Petersburg, , 190068
Status
Recruiting
Address
Hospital Unversitario Marques de Valdecilla /ID# 201604
Santander, Cantabria, 39008
Status
Completed
Address
Hospital Meixoeiro (CHUVI) /ID# 212084
Vigo, Pontevedra, 36213
Status
Recruiting
Address
Hospital Universitario Canarias /ID# 224928
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
Status
Recruiting
Address
Hospital Universitario Basurto /ID# 224730
Bilbao, Vizcaya, 48013
Status
Recruiting
Address
Hospital Universitario A Coruna - CHUAC /ID# 224731
A Coruna, , 15006
Status
Recruiting
Address
Hospital Clinic de Barcelona /ID# 201878
Barcelona, , 08036
Status
Recruiting
Address
Hospital Universitario Virgen de las Nieves /ID# 224726
Granada, , 18014
Status
Recruiting
Address
Hospital General Universitario Gregorio Maranon /ID# 201326
Madrid, , 28007
Status
Recruiting
Address
Hospital Clinico Universitario San Carlos /ID# 204871
Madrid, , 28040
Status
Recruiting
Address
Hospital Universitario La Paz /ID# 241848
Madrid, , 28046
Status
Recruiting
Address
Skane University hospital /ID# 171407
Malmo, Skane Lan, 214 28
Status
Completed
Address
Karolinska University Hospital Solna /ID# 204945
Solna, Stockholms Lan, 171 64
Status
Recruiting
Address
Sahlgrenska University Hospital /ID# 171405
Gothenburg, Vastra Gotalands Lan, 413 46
Status
Completed
Address
Duplicate_Danderyds sjukhus /ID# 171404
Stockholm, , 182 88
Status
Recruiting
Address
Uppsala University Hospital /ID# 171403
Uppsala, , 75185
Status
Completed
Address
Duplicate_Vastmanlands Sjukhus /ID# 171429
Vasteras, , 723 35
Status
Active, not recruiting
Address
Universitätsspital Basel /ID# 201767
Basel, Basel-Stadt, 4031
Status
Active, not recruiting
Address
Kantonsspital St. Gallen /ID# 201134
St. Gallen, Sankt Gallen, 9007
Status
Active, not recruiting
Address
Inselspital, Universitätsspital Bern /ID# 201364
Bern, , 3010
Status
Completed
Address
HFR Fribourg - Hôpital cantonal /ID# 201114
Fribourg, , 1708
Status
Recruiting
Address
Royal United Hospitals Bath /ID# 239850
Bath, Bath And North East Somerset, BA1 3NG
Status
Recruiting
Address
Royal Devon University Healthcare NHS Foundation Trust /ID# 202834
Exeter, Devon, EX2 5DW
Status
Completed
Address
Barts Health NHS Trust /ID# 210511
London, London, City Of, E1 2ES
Status
Recruiting
Address
UH Coventry & Warwickshire /ID# 202838
Coventry, , CV2 2DX
Status
Recruiting
Address
Liverpool University University Hospitals NHS Foundation Trust /ID# 240391
Liverpool, , L9 7AL
Status
Recruiting
Address
University Hospitals Dorset NHS Foundation Trust /ID# 202836
Poole, , BH15 2JB
Status
Recruiting
Address
Portsmouth Hospitals University NHS Trust /ID# 225002
Portsmouth, , PO6 3LY
Status
Completed
Address
Southend Hospital /ID# 202839
Southend, , SS0 0RY
Status
Recruiting
Address
Torbay and South Devon Nhs Foundation Trust /Id# 224689
Torquay, , TQ2 7AA