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

Primary Purpose

Giant Cell Arteritis (GCA)

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Upadacitinib
Corticosteroid (CS)
Placebo
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Giant Cell Arteritis (GCA) focused on measuring Giant Cell Arteritis (GCA), ABT-494, Upadacitinib

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rheum Assoc of North Alabama /ID# 168668
  • Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 204702
  • VA Long Beach Healthcare System /ID# 203833
  • Robin K. Dore MD, Inc /ID# 201950
  • Denver Arthritis Clinic /ID# 171552
  • Western Connecticut Health Network- Germantown Rd /ID# 205071
  • Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 169040
  • Clinical Research of West Florida, Inc /ID# 201901
  • Lakes Research, LLC /ID# 210442
  • Ctr Arthritis & Rheumatic Dise /ID# 168667
  • Medallion Clinical Research Institute, LLC /ID# 168666
  • Omega Research Group /ID# 201903
  • IRIS Research and Development, LLC /ID# 169406
  • Clinical Research of West Florida - Tampa /ID# 201899
  • University of South Florida /ID# 207077
  • Lovelace Scientific Resources /ID# 169041
  • Arthritis and Rheumatology /ID# 170295
  • Institute of Arthritis Research /ID# 168490
  • Rush University Medical Center /ID# 224581
  • Ochsner Clinic Foundation /ID# 200723
  • The Arthritis & Diabetes Clinic, Inc. /ID# 171199
  • Ochsner Clinic Foundation-New Orleans /ID# 171200
  • Louisiana State Univ HSC /ID# 202646
  • Rheumatology Associates PA - Portland /ID# 225011
  • The Center for Rheumatology and Bone Research /ID# 168652
  • University of Michigan Hospitals /ID# 168645
  • Wayne State University Health Center /ID# 212755
  • Henry Ford Medical Center /ID# 207456
  • AA Medical Research Center - Grand Blanc /ID# 201854
  • Duplicate_West Michigan Rheumatology /ID# 168647
  • Clinvest Research LLC /ID# 208182
  • Physician Research Collaboration, LLC /ID# 168610
  • University Clinical Research Center /ID# 202504
  • University of Rochester Medical Center /ID# 213527
  • Marietta Memorial Hospital /ID# 210834
  • STAT Research, Inc. /ID# 200436
  • University of Pennsylvania /ID# 168655
  • Piedmont Arthritis Clinic, PA /ID# 212431
  • Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 212761
  • West Tennessee Research Institute /ID# 209256
  • Arthritis Associates of Kingsport /ID# 212756
  • Allen Arthritis /ID# 225527
  • Tekton Research, Inc. /ID# 201801
  • Precision Comprehensive Clinical Research Solutions /ID# 201798
  • West Texas Clinical Research /ID# 204834
  • Arthritis and Rheumatology Institute, PLLC /ID# 214612
  • Baylor Scott & White Center for Diagnostic Medicine /ID# 213529
  • University of Vermont Medical Center /ID# 211179
  • Carilion Clinic /ID# 212928
  • Kadlec Clinic Rheumatology /ID# 201618
  • University of Washington /ID# 201619
  • Aurora Rheumatology and Immunotherapy Center /ID# 201853
  • Froedtert Memorial Lutheran Hospital /ID# 224557
  • Emeritus Research Sydney /ID# 201937
  • Prince of Wales Hospital /ID# 210995
  • Griffith University /ID# 223829
  • The Queen Elizabeth Hospital /ID# 201939
  • Emeritus Research /ID# 201938
  • Fiona Stanley Hospital /ID# 201941
  • Medizinische Universitaet Innsbruck /ID# 201786
  • Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 201781
  • CHU UCL Namur - site Godinne /ID# 224334
  • UZ Gent /ID# 202778
  • Universitair Ziekenhuis Leuven /ID# 202779
  • University of Alberta Hospital - Division of Hematology /ID# 208629
  • St. Joseph's Healthcare /ID# 204160
  • CISSSBSL -Hopital regional de Rimouski /ID# 224266
  • Centre de Recherche Musculo-Squelettique /ID# 201224
  • Rheumatology Associates /ID# 201843
  • Fakultni nemocnice Olomouc /ID# 202041
  • Axon Clinical, s.r.o. /ID# 202468
  • MEDICAL PLUS, s.r.o. /ID# 200865
  • Aarhus University Hospital /ID# 171177
  • Sydvestjysk Sygehus /ID# 200216
  • Hopital Saint Joseph /ID# 171540
  • CHU Dijon /ID# 225277
  • CHU Toulouse - Hopital Purpan /ID# 171547
  • CHRU Lille - Hopital Claude Huriez /ID# 171543
  • CHU de Nantes, Hotel Dieu -HME /ID# 171544
  • HCL - Hopital de la Croix-Rousse /ID# 211184
  • Hopital de la Cavale Blanche /ID# 171549
  • CHU de CAEN - Hopital de la Cote de Nacre /ID# 171539
  • CHRU Tours - Hopital Trousseau /ID# 245232
  • Hopital Pitie Salpetriere /ID# 171542
  • AP-HP - Hopital Cochin /ID# 171545
  • Medius Klinik Kirchheim /ID# 200637
  • Universitaetsklinikum Tuebingen /ID# 223854
  • Immanuel Krankenhaus Berlin /ID# 223855
  • Medizinische Versorgungszentren Burghausen Altoetting /ID# 208773
  • Medizinische Hochschule Hannover /ID# 200632
  • Universitaetsklinikum Wuerzburg /ID# 213340
  • General Hospital of Athens Gennimatas /ID# 210129
  • General Hospital of Athens Ippokratio /ID# 202181
  • 424 General MILITARY Hospital /ID# 210973
  • Debreceni Egyetem Klinikai Kozpont /ID# 201526
  • Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 204018
  • Orszagos Reumatologiai es Fizioterapias Intezet /ID# 211454
  • Szent Imre Egyetemi Oktatokorhaz /ID# 201838
  • The Chaim Sheba Medical Center /ID# 241041
  • Bnai Zion Medical Center /ID# 240733
  • The Lady Davis Carmel Medical Center /ID# 240731
  • Azienda Sanitaria dell'Alto Adige/Ospedale di Bolzano /ID# 200081
  • Azienda Ospedaliero-Universitaria di Modena /ID# 200079
  • Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 200082
  • Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 202946
  • Kagawa University Hospital /ID# 200171
  • St. Marianna University Hospital /ID# 218692
  • Japanese Red Cross Kumamoto Hospital /ID# 203507
  • Tohoku University Hospital /ID# 200172
  • Okayama University Hospital /ID# 203156
  • Tomishiro Central Hospital /ID# 203897
  • Sakai City Medical Center /ID# 202643
  • Duplicate_Jichi Medical University Hosp /ID# 200169
  • St.Luke's International Hospital /ID# 200170
  • Radboud Universitair Medisch Centrum /ID# 212925
  • Zuyderland Medisch Centrum /ID# 224551
  • Erasmus Medisch Centrum /ID# 201717
  • ZiekenhuisGroep Twente /ID# 200038
  • Universitair Medisch Centrum Groningen /ID# 201715
  • Medisch Centrum Leeuwarden /ID# 201716
  • Optimal Clinical Trials Ltd /ID# 201946
  • Aotearoa Clinical Trials /ID# 201942
  • Timaru Medical Specialists Ltd /ID# 201943
  • Waikato Hospital /ID# 201944
  • CGM Research Trust /ID# 224061
  • Porter Rheumatology Ltd /ID# 223830
  • Drammen Sykehus /ID# 201560
  • Haukeland universitetssjukehus /ID# 201602
  • Rikshospitalet OUS HF /ID# 202004
  • Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 208151
  • Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 205186
  • Unidade Local de Saúde da Guarda, EPE /ID# 224878
  • Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 203530
  • Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 204887
  • Cabinet Medical Dr. Avram S.R.L /ID# 224336
  • Spitalul Clinic Sf. Maria /ID# 203809
  • Spitalul Clinic Colentina /ID# 204889
  • Kemerovo State Medical University /ID# 203676
  • Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 221643
  • Practicheskaya Medicina Clinic /ID# 224612
  • First Moscow State Medical University n.a I.M. Sechenov /ID# 203673
  • Euromedservice /ID# 205345
  • Clinical Rheumatologic Hospital No 25 /ID# 208950
  • Hospital Unversitario Marques de Valdecilla /ID# 201604
  • Hospital Meixoeiro (CHUVI) /ID# 212084
  • Hospital Universitario Canarias /ID# 224928
  • Hospital Universitario Basurto /ID# 224730
  • Hospital Universitario A Coruna - CHUAC /ID# 224731
  • Hospital Clinic de Barcelona /ID# 201878
  • Hospital Universitario Virgen de las Nieves /ID# 224726
  • Hospital General Universitario Gregorio Maranon /ID# 201326
  • Hospital Clinico Universitario San Carlos /ID# 204871
  • Hospital Universitario La Paz /ID# 241848
  • Skane University hospital /ID# 171407
  • Karolinska University Hospital Solna /ID# 204945
  • Sahlgrenska University Hospital /ID# 171405
  • Duplicate_Danderyds sjukhus /ID# 171404
  • Uppsala University Hospital /ID# 171403
  • Duplicate_Vastmanlands Sjukhus /ID# 171429
  • Universitätsspital Basel /ID# 201767
  • Kantonsspital St. Gallen /ID# 201134
  • Inselspital, Universitätsspital Bern /ID# 201364
  • HFR Fribourg - Hôpital cantonal /ID# 201114
  • Royal United Hospitals Bath /ID# 239850
  • Royal Devon University Healthcare NHS Foundation Trust /ID# 202834
  • Barts Health NHS Trust /ID# 210511
  • UH Coventry & Warwickshire /ID# 202838
  • Liverpool University University Hospitals NHS Foundation Trust /ID# 240391
  • University Hospitals Dorset NHS Foundation Trust /ID# 202836
  • Portsmouth Hospitals University NHS Trust /ID# 225002
  • Southend Hospital /ID# 202839
  • Torbay and South Devon Nhs Foundation Trust /Id# 224689

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Arm A

Arm B

Arm C

Arm Description

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

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

Placebo administered daily + 52-week CS taper regimen

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Sustained Remission
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

Percentage of Participants Achieving Sustained Complete Remission
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.
Cumulative Corticosteroid (CS) exposure
The cumulative exposure to corticosteroid(s) is assessed.
Time to First Disease Flare
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.
Percentage of Participants Who Experience at Least 1 Disease Flare
The percentage of participants who experience at least 1 disease flare is assessed
Percentage of Participants in Complete Remission
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.
Change from Baseline in the 36-item Short Form Quality of Life Questionnaire (SF-36) Physical Component Score (PCS)
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.
Number of Disease Flares per Participant
The number of disease flares per participant during Period 1 will be assessed.
Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
The FACIT-Fatigue 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-Fatigue 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.
Assessment of Treatment Satisfaction Questionnaire for Medication (TSQM) Patient Global Satisfaction Subscale
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.
Rate of CS-related Adverse Events
The rate of CS-related adverse events will be assessed.

Full Information

First Posted
October 27, 2018
Last Updated
September 7, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03725202
Brief Title
A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis
Acronym
SELECT-GCA
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 24, 2019 (Actual)
Primary Completion Date
February 7, 2024 (Anticipated)
Study Completion Date
March 3, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

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
Data Monitoring Committee
Yes

5. 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 sustained remission in Period 1.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Giant Cell Arteritis (GCA)
Keywords
Giant Cell Arteritis (GCA), ABT-494, Upadacitinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
429 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Upadacitinib dose A administered daily + 26-week CS taper regimen
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Upadacitinib dose B administered daily + 26-week CS taper regimen
Arm Title
Arm C
Arm Type
Placebo Comparator
Arm Description
Placebo administered daily + 52-week CS taper regimen
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
ABT-494, RINVOQ
Intervention Description
It will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Corticosteroid (CS)
Intervention Description
It will be administered orally.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
It will be administered orally.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Sustained Remission
Description
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.
Time Frame
At Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Sustained Complete Remission
Description
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.
Time Frame
Week 12 through Week 52
Title
Cumulative Corticosteroid (CS) exposure
Description
The cumulative exposure to corticosteroid(s) is assessed.
Time Frame
Up to Week 52
Title
Time to First Disease Flare
Description
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.
Time Frame
Up to Week 52
Title
Percentage of Participants Who Experience at Least 1 Disease Flare
Description
The percentage of participants who experience at least 1 disease flare is assessed
Time Frame
Up to Week 52
Title
Percentage of Participants in Complete Remission
Description
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.
Time Frame
Up to Week 52
Title
Change from Baseline in the 36-item Short Form Quality of Life Questionnaire (SF-36) Physical Component Score (PCS)
Description
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.
Time Frame
At Week 52
Title
Number of Disease Flares per Participant
Description
The number of disease flares per participant during Period 1 will be assessed.
Time Frame
Up to Week 52
Title
Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Description
The FACIT-Fatigue 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-Fatigue 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.
Time Frame
From Week 0 to Week 52
Title
Assessment of Treatment Satisfaction Questionnaire for Medication (TSQM) Patient Global Satisfaction Subscale
Description
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.
Time Frame
At Week 52
Title
Rate of CS-related Adverse Events
Description
The rate of CS-related adverse events will be assessed.
Time Frame
At Week 52

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=M16-852
Description
Description Related Info

Learn more about this trial

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

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