Clinical trial NCT03725202: A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Giant Cell Arteritis (GCA)
Keywords: Giant Cell Arteritis (GCA)
ABT-494
Upadacitinib
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-10-30
Enrollment: 438
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Safety and efficacy data through 06 February 2024 are included in the interim analysis, which was conducted after all participants completed the Week 52 visit or discontinued from the study.


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.

Primary outcomes:
measure: Percentage of Participants Achieving Sustained Remission at Week 52
timeFrame: From Week 12 to Week 52
Secondary outcomes:
measure: Percentage of Participants Achieving Sustained Complete Remission From Week 12 Through Week 52
timeFrame: Week 12 through Week 52
measure: Cumulative Corticosteroid (CS) Exposure Through Week 52
timeFrame: Baseline up to Week 52
measure: Time to First Disease Flare Through Week 52
timeFrame: Baseline up to Week 52
measure: Percentage of Participants Who Experience at Least 1 Disease Flare Through Week 52
timeFrame: Baseline up to Week 52
measure: Percentage of Participants in Complete Remission at Week 52
timeFrame: At Week 52
measure: Percentage of Participants in Complete Remission at Week 24
timeFrame: At Week 24
measure: Change From Baseline in the 36-item Short Form Quality of Life Questionnaire (SF-36) Physical Component Summary (PCS) Score at Week 52
timeFrame: Baseline, Week 52
measure: Number of Disease Flares Per Participant Through Week 52
timeFrame: Baseline up to Week 52
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) at Week 52
timeFrame: Baseline, Week 52
measure: Assessment of Treatment Satisfaction Questionnaire for Medication (TSQM) Patient Global Satisfaction Subscale at Week 52
timeFrame: At Week 52
measure: Rate of Corticosteroid-related Adverse Events Though Week 52
timeFrame: Baseline up to Week 52
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Rheum Assoc of North Alabama /ID# 168668
state: Alabama
city: Glendale
country: United States
facility: Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 204702
state: Arizona
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System /ID# 203833
state: California
city: Tustin
country: United States
facility: Robin K. Dore MD, Inc /ID# 201950
state: California
city: Denver
country: United States
facility: Denver Arthritis Clinic /ID# 171552
state: Colorado
city: Danbury
country: United States
facility: Duplicate_Western Connecticut Health Network- Germantown Rd /ID# 205071
state: Connecticut
city: Boca Raton
country: United States
facility: Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 169040
state: Florida
city: Miami
country: United States
facility: Lakes Research, LLC /ID# 210442
state: Florida
city: Miami
country: United States
facility: Ctr Arthritis & Rheumatic Dise /ID# 168667
state: Florida
city: Naples
country: United States
facility: Medallion Clinical Research Institute, LLC /ID# 168666
state: Florida
city: Orlando
country: United States
facility: Omega Research Group /ID# 201903
state: Florida
city: Plantation
country: United States
facility: IRIS Research and Development, LLC /ID# 169406
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida - Tampa /ID# 201899
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc /ID# 201901
state: Florida
city: Tampa
country: United States
facility: Duplicate_University of South Florida /ID# 207077
state: Florida
city: Venice
country: United States
facility: Lovelace Scientific Resources /ID# 169041
state: Florida
city: Atlanta
country: United States
facility: Arthritis and Rheumatology /ID# 170295
state: Georgia
city: Idaho Falls
country: United States
facility: Institute of Arthritis Research /ID# 168490
state: Idaho
city: Chicago
country: United States
facility: Duplicate_Rush University Medical Center /ID# 224581
state: Illinois
city: Baton Rouge
country: United States
facility: Ochsner Clinic Foundation /ID# 200723
state: Louisiana
city: Monroe
country: United States
facility: The Arthritis & Diabetes Clinic, Inc. /ID# 171199
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation-New Orleans /ID# 171200
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana State Univ HSC /ID# 202646
state: Louisiana
city: Portland
country: United States
facility: Rheumatology Associates PA - Portland /ID# 225011
state: Maine
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research /ID# 168652
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Hospitals /ID# 168645
state: Michigan
city: Detroit
country: United States
facility: Wayne State University Health Center /ID# 212755
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Medical Center - New Center One /ID# 207456
state: Michigan
city: Grand Blanc
country: United States
facility: Duplicate_AA Medical Research Center - Grand Blanc /ID# 201854
state: Michigan
city: Grand Rapids
country: United States
facility: Duplicate_West Michigan Rheumatology /ID# 168647
state: Michigan
city: Springfield
country: United States
facility: Clinvest Research LLC /ID# 208182
state: Missouri
city: Lincoln
country: United States
facility: Physician Research Collaboration, LLC /ID# 168610
state: Nebraska
city: Somerset
country: United States
facility: University Clinical Research Center /ID# 202504
state: New Jersey
city: Rochester
country: United States
facility: University of Rochester Medical Center /ID# 213527
state: New York
city: Marietta
country: United States
facility: Marietta Memorial Hospital /ID# 210834
state: Ohio
city: Vandalia
country: United States
facility: STAT Research, Inc. /ID# 200436
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania /ID# 168655
state: Pennsylvania
city: Greenville
country: United States
facility: Piedmont Arthritis Clinic, PA /ID# 212431
state: South Carolina
city: Summerville
country: United States
facility: Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 212761
state: South Carolina
city: Jackson
country: United States
facility: West Tennessee Research Institute /ID# 209256
state: Tennessee
city: Kingsport
country: United States
facility: Arthritis Associates of Kingsport /ID# 212756
state: Tennessee
city: Allen
country: United States
facility: Allen Arthritis /ID# 225527
state: Texas
city: Austin
country: United States
facility: Tekton Research, L.L.C /ID# 201801
state: Texas
city: Colleyville
country: United States
facility: Precision Comprehensive Clinical Research Solutions /ID# 201798
state: Texas
city: Lubbock
country: United States
facility: West Texas Clinical Research /ID# 204834
state: Texas
city: Plano
country: United States
facility: Arthritis and Rheumatology Institute, PLLC /ID# 214612
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Center for Diagnostic Medicine /ID# 213529
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center /ID# 211179
state: Vermont
city: Roanoke
country: United States
facility: Carilion Clinic /ID# 212928
state: Virginia
city: Kennewick
country: United States
facility: Kadlec Clinic Rheumatology /ID# 201618
state: Washington
city: Seattle
country: United States
facility: University of Washington /ID# 201619
state: Washington
city: Franklin
country: United States
facility: Aurora Rheumatology and Immunotherapy Center /ID# 201853
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert Memorial Lutheran Hospital /ID# 224557
state: Wisconsin
city: Botany
country: Australia
facility: Emeritus Research Sydney /ID# 201937
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital /ID# 210995
state: New South Wales
city: Southport
country: Australia
facility: Griffith University /ID# 223829
state: Queensland
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital /ID# 201939
state: South Australia
city: Camberwell
country: Australia
facility: Emeritus Research /ID# 201938
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital /ID# 201941
state: Western Australia
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck /ID# 201786
state: Tirol
city: Vienna
country: Austria
facility: Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 201781
state: Wien
city: Yvoir
country: Belgium
facility: Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 224334
state: Namur
city: Gent
country: Belgium
facility: UZ Gent /ID# 202778
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven /ID# 202779
state: Vlaams-Brabant
city: Edmonton
country: Canada
facility: Duplicate_University of Alberta Hospital - Division of Hematology /ID# 208629
state: Alberta
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare /ID# 204160
state: Ontario
city: Rimouski
country: Canada
facility: CISSSBSL -Hopital regional de Rimouski /ID# 224266
state: Quebec
city: Trois-rivières
country: Canada
facility: Centre de Recherche Musculo-Squelettique /ID# 201224
state: Quebec
city: Saskatoon
country: Canada
facility: Rheumatology Associates /ID# 201843
state: Saskatchewan
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc /ID# 202041
city: Praha
country: Czechia
facility: Axon Clinical, s.r.o. /ID# 202468
city: Uherske Hradiste
country: Czechia
facility: Medical Plus, s.r.o. /ID# 200865
city: Aarhus C
country: Denmark
facility: Aarhus University Hospital /ID# 171177
state: Midtjylland
city: Esbjerg
country: Denmark
facility: Sydvestjysk Sygehus /ID# 200216
state: Syddanmark
city: Marseille
country: France
facility: Hopital Saint Joseph /ID# 171540
state: Bouches-du-Rhone
city: Dijon
country: France
facility: CHU Dijon /ID# 225277
state: Cote-d Or
city: Brest
country: France
facility: Hopital de la Cavale Blanche /ID# 171549
state: Finistere
city: TOULOUSE Cedex 9
country: France
facility: CHU Toulouse - Hopital Purpan /ID# 171547
state: Haute-Garonne
city: Paris
country: France
facility: Hopital Pitie Salpetriere /ID# 171542
state: Ile-de-France
city: Lille
country: France
facility: CHRU Lille - Hopital Claude Huriez /ID# 171543
state: Nord
city: Paris CEDEX 14
country: France
facility: Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 171545
state: Paris
city: Nantes
country: France
facility: CHU de Nantes, Hotel Dieu -HME /ID# 171544
state: Pays-de-la-Loire
city: Lyon
country: France
facility: HCL - Hopital de la Croix-Rousse /ID# 211184
state: Rhone
city: Caen
country: France
facility: CHU de CAEN - Hopital de la Cote de Nacre /ID# 171539
city: Chambray Les Tours
country: France
facility: CHRU Tours - Hopital Trousseau /ID# 245232
city: Kirchheim unter Teck
country: Germany
facility: Medius Klinik Kirchheim /ID# 200637
state: Baden-Wuerttemberg
city: Tubingen
country: Germany
facility: Universitaetsklinikum Tuebingen /ID# 223854
state: Baden-Wuerttemberg
city: Wuerzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg /ID# 213340
state: Bayern
city: Berlin-buch
country: Germany
facility: Immanuel Krankenhaus Berlin /ID# 223855
city: Burghausen
country: Germany
facility: Medizinische Versorgungszentren Burghausen Altoetting /ID# 208773
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover /ID# 200632
city: Athens
country: Greece
facility: General Hospital of Athens Gennimatas /ID# 210129
state: Attiki
city: Athens
country: Greece
facility: General Hospital of Athens Ippokratio /ID# 202181
state: Attiki
city: Efkarpia (Thessalonikis)
country: Greece
facility: 424 General MILITARY Hospital /ID# 210973
state: Thessaloniki
city: Debrecen
country: Hungary
facility: Debreceni Egyetem-Klinikai Kozpont /ID# 201526
state: Hajdu-Bihar
city: Budapest
country: Hungary
facility: Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 204018
city: Budapest
country: Hungary
facility: Orszagos Reumatologiai es Fizioterapias Intezet /ID# 211454
city: Budapest
country: Hungary
facility: Del-Budai Centrumkorhaz Szent Imre Egyetemi Oktatokorhaz /ID# 201838
city: Haifa
country: Israel
facility: Bnai Zion Medical Center /ID# 240733
state: H_efa
city: Haifa
country: Israel
facility: The Lady Davis Carmel Medical Center /ID# 240731
state: H_efa
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 241041
state: Tel-Aviv
city: Bolzano
country: Italy
facility: Azienda Sanitaria dell'Alto Adige /ID# 200081
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena /ID# 200079
city: Udine
country: Italy
facility: Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 200082
city: Nagoya-shi
country: Japan
facility: Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 202946
state: Aichi
city: Kita-gun
country: Japan
facility: Kagawa University Hospital /ID# 200171
state: Kagawa
city: Kawasaki-shi
country: Japan
facility: St. Marianna University Hospital /ID# 218692
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Duplicate_Japanese Red Cross Kumamoto Hospital /ID# 203507
state: Kumamoto
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital /ID# 200172
state: Miyagi
city: Okayama-shi
country: Japan
facility: Okayama University Hospital /ID# 203156
state: Okayama
city: Tomigusuku-shi
country: Japan
facility: Tomishiro Central Hospital /ID# 203897
state: Okinawa
city: Sakai-shi
country: Japan
facility: Sakai City Medical Center /ID# 202643
state: Osaka
city: Shimotsuke-shi
country: Japan
facility: Duplicate_Jichi Medical University Hosp /ID# 200169
state: Tochigi
city: Chuo-ku
country: Japan
facility: St.Luke's International Hospital /ID# 200170
state: Tokyo
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden /ID# 201716
state: Friesland
city: Nijmegen
country: Netherlands
facility: Radboud Universitair Medisch Centrum /ID# 212925
state: Gelderland
city: Heerlen
country: Netherlands
facility: Zuyderland Medisch Centrum /ID# 224551
state: Limburg
city: Almelo
country: Netherlands
facility: ZiekenhuisGroep Twente /ID# 200038
state: Overijssel
city: Rotterdam
country: Netherlands
facility: Duplicate_Erasmus Medisch Centrum /ID# 201717
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen /ID# 201715
city: Grafotn
country: New Zealand
facility: Optimal Clinical Trials Ltd /ID# 201946
state: Auckland
city: Papatoetoe
country: New Zealand
facility: Aotearoa Clinical Trials /ID# 201942
state: Auckland
city: Timaru
country: New Zealand
facility: Timaru Medical Specialists Ltd /ID# 201943
state: Canterbury
city: Hamilton
country: New Zealand
facility: Waikato Hospital /ID# 201944
state: Waikato
city: Christchurch Central
country: New Zealand
facility: CGM Research Trust /ID# 224061
city: Nelson
country: New Zealand
facility: Porter Rheumatology Ltd /ID# 223830
city: Drammen
country: Norway
facility: Drammen Sykehus /ID# 201560
state: Buskerud
city: Bergen
country: Norway
facility: Haukeland universitetssjukehus /ID# 201602
state: Hordaland
city: Oslo
country: Norway
facility: Rikshospitalet OUS HF /ID# 202004
city: Vila Nova de Gaia
country: Portugal
facility: Unidade Local de Saude de Gaia/Espinho, EPE /ID# 208151
state: Porto
city: Ponte de Lima
country: Portugal
facility: Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 205186
state: Viana Do Castelo
city: Guarda
country: Portugal
facility: Unidade Local de Saúde da Guarda, EPE /ID# 224878
city: Lisboa
country: Portugal
facility: Unidade Local de Saude de Santa Maria, EPE /ID# 203530
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 204887
state: Cluj
city: Timisoara
country: Romania
facility: Cabinet Medical Dr. Avram S.R.L /ID# 224336
state: Timis
city: Bucuresti
country: Romania
facility: Spitalul Clinic Sf. Maria /ID# 203809
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina /ID# 204889
city: Kemerovo
country: Russian Federation
facility: Kemerovo State Medical University /ID# 203676
state: Kemerovskaya Oblast
city: Moscow
country: Russian Federation
facility: Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 221643
state: Moskovskaya Oblast
city: Moscow
country: Russian Federation
facility: Practicheskaya Medicina Clinic /ID# 224612
city: Moscow
country: Russian Federation
facility: First Moscow State Medical University n.a I.M. Sechenov /ID# 203673
city: Pushkin
country: Russian Federation
facility: Euromedservice /ID# 205345
city: St. Petersburg
country: Russian Federation
facility: Clinical Rheumatologic Hospital No 25 /ID# 208950
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña /ID# 224731
state: A Coruna
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla /ID# 201604
state: Cantabria
city: Vigo
country: Spain
facility: Hospital Meixoeiro (CHUVI) /ID# 212084
state: Pontevedra
city: San Cristóbal de La Laguna
country: Spain
facility: Hospital Universitario Canarias /ID# 224928
state: Santa Cruz De Tenerife
city: Bilbao
country: Spain
facility: Hospital Universitario Basurto /ID# 224730
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona /ID# 201878
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves /ID# 224726
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon /ID# 201326
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos /ID# 204871
city: Madrid
country: Spain
facility: Hospital Universitario La Paz /ID# 241848
city: Malmo
country: Sweden
facility: Skane University hospital /ID# 171407
state: Skane Lan
city: Solna
country: Sweden
facility: Karolinska University Hospital Solna /ID# 204945
state: Stockholms Lan
city: Uppsala
country: Sweden
facility: Uppsala University Hospital /ID# 171403
state: Uppsala Lan
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset /ID# 171405
state: Vastra Gotalands Lan
city: Stockholm
country: Sweden
facility: Duplicate_Danderyds sjukhus /ID# 171404
city: Vasteras
country: Sweden
facility: Duplicate_Vastmanlands Sjukhus /ID# 171429
city: Basel Town
country: Switzerland
facility: Universitätsspital Basel /ID# 201767
state: Basel-Stadt
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen /ID# 201134
state: Sankt Gallen
city: Bern
country: Switzerland
facility: Inselspital, Universitaetsspital Bern /ID# 201364
city: Fribourg
country: Switzerland
facility: HFR Fribourg - Hôpital cantonal /ID# 201114
city: Bath
country: United Kingdom
facility: Royal United Hospitals Bath /ID# 239850
state: Bath And North East Somerset
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter Hospital /ID# 202834
state: Devon
city: Poole
country: United Kingdom
facility: University Hospitals Dorset NHS Foundation Trust /ID# 202836
state: Dorset
city: London
country: United Kingdom
facility: Barts Health NHS Trust /ID# 210511
state: Greater London
city: Coventry
country: United Kingdom
facility: UH Coventry & Warwickshire /ID# 202838
state: Warwickshire
city: Liverpool
country: United Kingdom
facility: Liverpool University University Hospitals NHS Foundation Trust /ID# 240391
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals University NHS Trust /ID# 225002
city: Southend
country: United Kingdom
facility: Southend Hospital /ID# 202839
city: Torquay
country: United Kingdom
facility: Torbay and South Devon Nhs Foundation Trust /Id# 224689
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: