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

Sponsor
AbbVie (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03725202
Collaborator
(none)
420
Enrollment
174
Locations
3
Arms
70
Anticipated Duration (Months)
2.4
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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 remission in Period 1.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
420 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 24, 2019
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Nov 25, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A

Upadacitinib dose A administered daily + 26-week CS taper regimen

Drug: Upadacitinib
It will be administered orally.
Other Names:
  • ABT-494
  • RINVOQ

    • Drug: Corticosteroid (CS)
    It will be administered orally.
    Experimental: Arm B

    Upadacitinib dose B administered daily + 26-week CS taper regimen

    Drug: Upadacitinib
    It will be administered orally.
    Other Names:
  • ABT-494
  • RINVOQ

    • Drug: Corticosteroid (CS)
    It will be administered orally.
    Placebo Comparator: Arm C

    Placebo administered daily + 52-week CS taper regimen

    Drug: Corticosteroid (CS)
    It will be administered orally.

    Other: Placebo
    It will be administered orally.

    Outcome Measures

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    1. Percentage of Participants Achieving Sustained Complete Remission [Week 12 through Week 52]

      Sustained complete remission is defined as having absence of GCA signs and symptoms; normalization of erythrocyte sedimentation rate (ESR); Normalization of high sensitivity C-reactive protein (hs-CRP) and adherence to the protocol-defined CS taper regimen.

    2. Cumulative Corticosteroid (CS) exposure [Up to Week 52]

      The cumulative exposure to corticosteroid(s) is assessed.

    3. Time to First Disease Flare [Up to Week 52]

      Disease flare is defined as an event determined by the investigator to represent recurrence of GCA signs or symptoms or an ESR measurement > 30 mm/hr (attributable to GCA) AND requiring an increase in CS dose.

    4. Percentage of Participants Who Experience at Least 1 Disease Flare [Up to Week 52]

      The percentage of participants who experience at least 1 disease flare is assessed

    5. Percentage of Participants in Complete Remission [Up to Week 52]

      Complete remission is defined as having achieved absence of GCA signs and symptoms; normalization of ESR; normalization of hs-CRP and adherence to the protocol-defined CS taper regimen.

    6. Change from Baseline in the 36-item Short Form Quality of Life Questionnaire (SF-36) Physical Component Score (PCS) [At Week 52]

      The SF-36 is a generic health-related quality-of-life instrument that can be used across age, disease and treatment groups and includes 8 domains: physical functioning, role limitations due to physical health problems, role limitations due to emotional health problems, social functioning, pain, energy/fatigue, emotional well-being, and general health problems.

    7. Number of Disease Flares per Participant During Period 1 [Up to Week 52]

      The number of disease flares per participant during Period 1 will be assessed.

    8. Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) [From Week 0 to Week 52]

      The FACIT-F is a 13-item electronic-patient reported outcome (ePRO) measure of fatigue, which has been validated in the general population and in other chronic diseases. The FACIT-F content and measurement validity and related reliability has been extensively tested in the psoriatic arthritis (PsA) population, with evidence of reliability, construct validity, and responsiveness.

    9. 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.

    10. Rate of CS-related Adverse Events [At Week 52]

      The rate of CS-related adverse events will be assessed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rheum Assoc of North Alabama /ID# 168668 Huntsville Alabama United States 35801
    2 Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 204702 Glendale Arizona United States 85306-9802
    3 VA Long Beach Healthcare System /ID# 203833 Long Beach California United States 90822-5201
    4 Robin K. Dore MD, Inc /ID# 201950 Tustin California United States 92780
    5 Denver Arthritis Clinic /ID# 171552 Denver Colorado United States 80230
    6 Western Connecticut Health Network- Germantown Rd /ID# 205071 Danbury Connecticut United States 06810-5038
    7 Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 169040 Boca Raton Florida United States 33486
    8 Clinical Research of West Florida, Inc /ID# 201901 Clearwater Florida United States 33765
    9 Lakes Research, LLC /ID# 210442 Miami Florida United States 33014
    10 Ctr Arthritis & Rheumatic Dise /ID# 168667 Miami Florida United States 33173
    11 Medallion Clinical Research Institute, LLC /ID# 168666 Naples Florida United States 34102
    12 Omega Research Maitland, LLC /ID# 201903 Orlando Florida United States 32808
    13 IRIS Research and Development, LLC /ID# 169406 Plantation Florida United States 33324
    14 Clinical Research of West Florida - Tampa /ID# 201899 Tampa Florida United States 33606-1246
    15 University of South Florida /ID# 207077 Tampa Florida United States 33612-2201
    16 Lovelace Scientific Resources /ID# 169041 Venice Florida United States 34292
    17 Arthritis and Rheumatology /ID# 170295 Atlanta Georgia United States 30342
    18 Institute of Arthritis Research /ID# 168490 Idaho Falls Idaho United States 83404
    19 Rush University Medical Center /ID# 224581 Chicago Illinois United States 60612
    20 Ochsner Clinic Foundation /ID# 200723 Baton Rouge Louisiana United States 70836-6455
    21 The Arthritis & Diabetes Clinic, Inc. /ID# 171199 Monroe Louisiana United States 71203
    22 Ochsner Clinic Foundation-New Orleans /ID# 171200 New Orleans Louisiana United States 70121
    23 Louisiana State Univ HSC /ID# 202646 Shreveport Louisiana United States 71130
    24 Rheumatology Associates PA - Portland /ID# 225011 Portland Maine United States 04102-2643
    25 The Center for Rheumatology and Bone Research /ID# 168652 Wheaton Maryland United States 20902
    26 University of Michigan Hospitals /ID# 168645 Ann Arbor Michigan United States 48109-5008
    27 Wayne State University Health Center /ID# 212755 Detroit Michigan United States 48201-2153
    28 Henry Ford Medical Center /ID# 207456 Detroit Michigan United States 48202-3046
    29 AA Medical Research Center - Grand Blanc /ID# 201854 Grand Blanc Michigan United States 48439
    30 Duplicate_West Michigan Rheumatology /ID# 168647 Grand Rapids Michigan United States 49546
    31 Clinvest Research LLC /ID# 208182 Springfield Missouri United States 65807
    32 Physician Research Collaboration, LLC /ID# 168610 Lincoln Nebraska United States 68516
    33 University Clinical Research Center /ID# 202504 Somerset New Jersey United States 08873-3448
    34 Univ Rochester Med Ctr /ID# 213527 Rochester New York United States 14642
    35 Wake Forest Baptist Health (Shepherd) /ID# 225157 Winston-Salem North Carolina United States 27103
    36 Marietta Memorial Hospital /ID# 210834 Marietta Ohio United States 45750-1635
    37 STAT Research, Inc. /ID# 200436 Vandalia Ohio United States 45377-9464
    38 University of Pennsylvania /ID# 168655 Philadelphia Pennsylvania United States 19104-5502
    39 UPMC Lupus Center of Excellence /ID# 240784 Pittsburgh Pennsylvania United States 15232-1531
    40 Piedmont Arthritis Clinic, PA /ID# 212431 Greenville South Carolina United States 29601
    41 Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 212761 Summerville South Carolina United States 29486-7887
    42 West Tennessee Research Institute /ID# 209256 Jackson Tennessee United States 38305
    43 Arthritis Associates of Kingsport /ID# 212756 Kingsport Tennessee United States 37660
    44 Allen Arthritis /ID# 225527 Allen Texas United States 75013
    45 Tekton Research, Inc. /ID# 201801 Austin Texas United States 78745
    46 Precision Comprehensive Clinical Research Solutions /ID# 201798 Colleyville Texas United States 76034
    47 West Texas Clinical Research /ID# 204834 Lubbock Texas United States 79410-1198
    48 Arthritis and Rheumatology Institute, PLLC /ID# 214612 Plano Texas United States 75093-6419
    49 Baylor Scott & White Center for Diagnostic Medicine /ID# 213529 Temple Texas United States 76508
    50 University of Vermont Medical Center /ID# 211179 Burlington Vermont United States 05401-1473
    51 Carilion Clinic /ID# 212928 Roanoke Virginia United States 24016
    52 Kadlec Clinic Rheumatology /ID# 201618 Kennewick Washington United States 99336
    53 University of Washington /ID# 201619 Seattle Washington United States 98109
    54 Aurora Rheumatology and Immunotherapy Center /ID# 201853 Franklin Wisconsin United States 53132
    55 Froedtert Memorial Lutheran Hospital /ID# 224557 Milwaukee Wisconsin United States 53226-3522
    56 Emeritus Research Sydney /ID# 201937 Botany New South Wales Australia 2019
    57 Prince of Wales Hospital /ID# 210995 Randwick New South Wales Australia 2031
    58 Griffith University /ID# 223829 Southport Queensland Australia 4222
    59 The Queen Elizabeth Hospital /ID# 201939 Woodville South South Australia Australia 5011
    60 Emeritus Research /ID# 201938 Camberwell Victoria Australia 3124
    61 Fiona Stanley Hospital /ID# 201941 Murdoch Western Australia Australia 6150
    62 Medizinische Universitaet Innsbruck /ID# 201786 Innsbruck Tirol Austria 6020
    63 Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 201781 Vienna Wien Austria 1100
    64 CHU UCL Namur - site Godinne /ID# 224334 Godinne Namur Belgium 5530
    65 UZ Gent /ID# 202778 Gent Oost-Vlaanderen Belgium 9000
    66 Universitair Ziekenhuis Leuven /ID# 202779 Leuven Vlaams-Brabant Belgium 3000
    67 University of Alberta Hospital - Division of Hematology /ID# 208629 Edmonton Alberta Canada T6G 2B7
    68 St. Joseph's Healthcare /ID# 204160 Hamilton Ontario Canada L8N 4A6
    69 CISSSBSL -Hopital regional de Rimouski /ID# 224266 Rimouski Quebec Canada G5L 5T1
    70 Centre de Recherche Musculo-Squelettique /ID# 201224 Trois-rivières Quebec Canada G8Z 1Y2
    71 Rheumatology Associates /ID# 201843 Saskatoon Saskatchewan Canada S7K 0H6
    72 Fakultni nemocnice Olomouc /ID# 202041 Olomouc Czechia 779 00
    73 Axon Clinical, s.r.o. /ID# 202468 Praha Czechia 140 00
    74 MEDICAL PLUS, s.r.o. /ID# 200865 Uherske Hradiste Czechia 686 01
    75 Aarhus University Hospital /ID# 171177 Aarhus C Midtjylland Denmark 8000
    76 Sydvestjysk Sygehus /ID# 200216 Esbjerg Denmark 6700
    77 Hopital Saint Joseph /ID# 171540 Marseille Bouches-du-Rhone France 13008
    78 CHU Dijon /ID# 225277 Dijon Cote-d Or France 21000
    79 CHU Toulouse - Hopital Purpan /ID# 171547 TOULOUSE Cedex 9 Haute-Garonne France 31059
    80 CHRU Lille - Hopital Claude Huriez /ID# 171543 Lille Hauts-de-France France 59037
    81 CHU de Nantes, Hotel Dieu -HME /ID# 171544 Nantes Pays-de-la-Loire France 44000
    82 Hopital de la Cavale Blanche /ID# 171549 Brest France 29200
    83 CHU de CAEN - Hopital de la Cote de Nacre /ID# 171539 Caen France 14033
    84 CHRU Tours - Hopital Trousseau /ID# 245232 Chambray Les Tours France 37170
    85 HCL - Hopital de la Croix-Rousse /ID# 211184 Lyon France 69004
    86 Hopital Pitie Salpetriere /ID# 171542 Paris France 75013
    87 AP-HP - Hopital Cochin /ID# 171545 Paris France 75014
    88 Medius Klinik Kirchheim /ID# 200637 Kirchheim unter Teck Baden-Wuerttemberg Germany 73230
    89 Universitaetsklinikum Tuebingen /ID# 223854 Tubingen Baden-Wuerttemberg Germany 72076
    90 Immanuel Krankenhaus Berlin /ID# 223855 Berlin-buch Germany 13125
    91 Medizinische Versorgungszentren Burghausen Altoetting /ID# 208773 Burghausen Germany 84489
    92 Medizinische Hochschule Hannover /ID# 200632 Hannover Germany 30625
    93 Universitaetsklinikum Wuerzburg /ID# 213340 Wuerzburg Germany 97080
    94 General Hospital of Athens Gennimatas /ID# 210129 Athens Attiki Greece 11527
    95 General Hospital of Athens Ippokratio /ID# 202181 Athens Attiki Greece 11527
    96 424 General MILITARY Hospital /ID# 210973 Efkarpia (Thessalonikis) Thessaloniki Greece 56429
    97 Debreceni Egyetem Klinikai Kozpont /ID# 201526 Debrecen Hajdu-Bihar Hungary 4032
    98 Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 204018 Budapest Hungary 1023
    99 Orszagos Reumatologiai es Fizioterapias Intezet /ID# 211454 Budapest Hungary 1023
    100 Szent Imre Egyetemi Oktatokorhaz /ID# 201838 Budapest Hungary 1115
    101 The Chaim Sheba Medical Center /ID# 241041 Ramat Gan Tel-Aviv Israel 5265601
    102 Bnai Zion Medical Center /ID# 240733 Haifa Israel 3339419
    103 The Lady Davis Carmel Medical Center /ID# 240731 Haifa Israel 34362
    104 Azienda Sanitaria dell'Alto Adige/Ospedale di Bolzano /ID# 200081 Bolzano Italy 39100
    105 Azienda Ospedaliero-Universitaria di Modena /ID# 200079 Modena Italy 41124
    106 Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 200082 Udine Italy 33100
    107 Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 202946 Nagoya-shi Aichi Japan 455-8530
    108 Kagawa University Hospital /ID# 200171 Kita-gun Kagawa Japan 761-0793
    109 St. Marianna University Hospital /ID# 218692 Kawasaki-shi Kanagawa Japan 216-8511
    110 Japanese Red Cross Kumamoto Hospital /ID# 203507 Kumamoto-shi Kumamoto Japan 861-8520
    111 Tohoku University Hospital /ID# 200172 Sendai-shi Miyagi Japan 9808574
    112 Okayama University Hospital /ID# 203156 Okayama-shi Okayama Japan 700-8558
    113 Tomishiro Central Hospital /ID# 203897 Tomigusuku-shi Okinawa Japan 901-0243
    114 Sakai City Medical Center /ID# 202643 Sakai-shi Osaka Japan 593-8304
    115 Duplicate_Jichi Medical University Hosp /ID# 200169 Shimotsuke-shi Tochigi Japan 329-0431
    116 St.Luke's International Hospital /ID# 200170 Chuo-ku Tokyo Japan 104-8560
    117 Radboud Universitair Medisch Centrum /ID# 212925 Nijmegen Gelderland Netherlands 6525 GA
    118 Zuyderland Medisch Centrum /ID# 224551 Heerlen Limburg Netherlands 6419 PC
    119 Erasmus Medisch Centrum /ID# 201717 Rotterdam Zuid-Holland Netherlands 3015 GD
    120 ZiekenhuisGroep Twente /ID# 200038 Almelo Netherlands 7609 PP
    121 Universitair Medisch Centrum Groningen /ID# 201715 Groningen Netherlands 9713 GZ
    122 Medisch Centrum Leeuwarden /ID# 201716 Leeuwarden Netherlands 8934 AD
    123 Optimal Clinical Trials Ltd /ID# 201946 Grafotn Auckland New Zealand 1010
    124 Middlemore Clinical Trials /ID# 201942 Papatoetoe Auckland New Zealand 2025
    125 Timaru Medical Specialists Ltd /ID# 201943 Timaru Canterbury New Zealand 7910
    126 Waikato Hospital /ID# 201944 Hamilton Waikato New Zealand 3240
    127 CGM Research Trust /ID# 224061 Christchurch Central New Zealand 8011
    128 Porter Rheumatology Ltd /ID# 223830 Nelson New Zealand 7010
    129 Drammen Sykehus /ID# 201560 Drammen Buskerud Norway 3004
    130 Haukeland universitetssjukehus /ID# 201602 Bergen Hordaland Norway 5021
    131 Rikshospitalet OUS HF /ID# 202004 Oslo Norway 0450
    132 Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 208151 Vila Nova De Gaia Porto Portugal 4434-502
    133 Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 205186 Ponte de Lima Viana Do Castelo Portugal 4990-041
    134 Unidade Local de Saúde da Guarda, EPE /ID# 224878 Guarda Portugal 6300-035
    135 Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 203530 Lisboa Portugal 1649-035
    136 Cabinet Dr. Avram S.R.L. /ID# 224336 Timisoara Timis Romania 300134
    137 Spitalul Clinic Sf. Maria /ID# 203809 Bucuresti Romania 011172
    138 Spitalul Clinic Colentina /ID# 204889 Bucuresti Romania 020121
    139 Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 204887 Cluj-Napoca Romania 400006
    140 Kemerovo State Medical University /ID# 203676 Kemerovo Kemerovskaya Oblast Russian Federation 650056
    141 Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 221643 Moscow Moskovskaya Oblast Russian Federation 129110
    142 Practicheskaya Medicina Clinic /ID# 224612 Moscow Russian Federation 115372
    143 First Moscow State Medical University n.a I.M. Sechenov /ID# 203673 Moscow Russian Federation 119992
    144 Euromedservice /ID# 205345 Pushkin Russian Federation 196603
    145 Clinical Rheumatologic Hospital No 25 /ID# 208950 St. Petersburg Russian Federation 190068
    146 Hospital Unversitario Marques de Valdecilla /ID# 201604 Santander Cantabria Spain 39008
    147 Hospital Meixoeiro (CHUVI) /ID# 212084 Vigo Pontevedra Spain 36213
    148 Hospital Universitario Canarias /ID# 224928 San Cristóbal de La Laguna Santa Cruz De Tenerife Spain 38320
    149 Hospital Universitario Basurto /ID# 224730 Bilbao Vizcaya Spain 48013
    150 Hospital Universitario A Coruna - CHUAC /ID# 224731 A Coruna Spain 15006
    151 Hospital Clinic de Barcelona /ID# 201878 Barcelona Spain 08036
    152 Hospital Universitario Virgen de las Nieves /ID# 224726 Granada Spain 18014
    153 Hospital General Universitario Gregorio Maranon /ID# 201326 Madrid Spain 28007
    154 Hospital Clinico Universitario San Carlos /ID# 204871 Madrid Spain 28040
    155 Hospital Universitario La Paz /ID# 241848 Madrid Spain 28046
    156 Skane University hospital /ID# 171407 Malmo Skane Lan Sweden 214 28
    157 Karolinska University Hospital Solna /ID# 204945 Solna Stockholms Lan Sweden 171 64
    158 Sahlgrenska University Hospital /ID# 171405 Gothenburg Vastra Gotalands Lan Sweden 413 46
    159 Duplicate_Danderyds sjukhus /ID# 171404 Stockholm Sweden 182 88
    160 Uppsala University Hospital /ID# 171403 Uppsala Sweden 75185
    161 Duplicate_Vastmanlands Sjukhus /ID# 171429 Vasteras Sweden 723 35
    162 Universitätsspital Basel /ID# 201767 Basel Basel-Stadt Switzerland 4031
    163 Kantonsspital St. Gallen /ID# 201134 St. Gallen Sankt Gallen Switzerland 9007
    164 Inselspital, Universitätsspital Bern /ID# 201364 Bern Switzerland 3010
    165 HFR Fribourg - Hôpital cantonal /ID# 201114 Fribourg Switzerland 1708
    166 Royal United Hospitals Bath /ID# 239850 Bath Bath And North East Somerset United Kingdom BA1 3NG
    167 Royal Devon and Exeter NHS Trust Hospital /ID# 202834 Exeter Devon United Kingdom EX2 5DW
    168 Barts Health NHS Trust /ID# 210511 London London, City Of United Kingdom E1 2ES
    169 UH Coventry & Warwickshire /ID# 202838 Coventry United Kingdom CV2 2DX
    170 Liverpool University University Hospitals NHS Foundation Trust /ID# 240391 Liverpool United Kingdom L9 7AL
    171 University Hospitals Dorset NHS Foundation Trust /ID# 202836 Poole United Kingdom BH15 2JB
    172 Portsmouth Hospitals University NHS Trust /ID# 225002 Portsmouth United Kingdom PO6 3LY
    173 Southend Hospital /ID# 202839 Southend United Kingdom SS0 0RY
    174 Torbay and South Devon Nhs Foundation Trust /Id# 224689 Torquay United Kingdom TQ2 7AA

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT03725202
    Other Study ID Numbers:
    • M16-852
    • 2017-003978-13
    First Posted:
    Oct 30, 2018
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by AbbVie
    Giant Cell Arteritis (GCA)
    ABT-494
    Upadacitinib
    Additional relevant MeSH terms:
    Polymyalgia Rheumatica
    Giant Cell Arteritis
    Arteritis
    Upadacitinib

    Study Results

    No Results Posted as of Aug 25, 2022