Clinical trial NCT05843643: Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus
Official title: SELECT-SLE: A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Moderately to Severely Active SLE
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic Lupus Erythematosus
SLE
Upadacitinib
Lupus
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-05-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will assess how safe and effective upadacitinib is in treating adult participants with moderately to severely active SLE. Adverse events and change in the disease activity will be assessed.

Upadacitinib is an approved drug for rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of SLE. This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo (does not contain treatment drug) . This study comprised of 4 sub studies. In Study 1 and Study 2, study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Eligible participants from Study 1 and Study 2 will enter Study 3 at week 52 to receive specific doses of upadacitinib. Study 4 is a 104-week continued extension if participation is likely to provide a benefit to their SLE. Approximately 500 participants diagnosed with SLE will be enrolled in each of the Study 1 and Study 2 in approximately 320 sites across the world.

Participants will receive oral tablets of upadacitinib or matching placebo once daily for 52 weeks in Study 1 and Study 2. Eligible participants from Study 1 and Study 2 will receive oral tablets of upadacitinib once daily for 52 weeks in Study 3.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of systemic lupus erythematosus (SLE) at least 24 weeks prior to screening as defined by the 2019 European Alliance of Associations for Rheumatology (EULAR)/ American College of Rheumatology (ACR) classification criteria for SLE.
* At Screening, must have at least one of the following:

  * antinuclear antibody (ANA) positive (titer \>= 1:80)
  * anti-double stranded deoxyribonucleic acid (dsDNA) positive
  * anti-Smith positive
* Hybrid systemic lupus erythematosus disease activity index (hSLEDAI) \>= 6, of which \>= 4 points are clinical (not based on laboratory criteria), independently reviewed by the MCDR at Screening. Clinical hSLEDAI score (not based on laboratory criteria) must be re-confirmed as \>= 4 at the Baseline visit. Lupus headache or organic brain syndrome do not count towards the hSLEDAI points required for eligibility but should be documented on the hSLEDAI if present.
* Physician's Global Assessment (PhGA) \>= 1 during screening period.
* On stable background treatment for \>= 60 days prior to Baseline (with the exception of oral corticosteroid \[OCS\], which must be at a stable dose for \>=14 days prior to Baseline) with

  * antimalarial(s) \[hydroxychloroquine \<= 400 mg daily, chloroquine \<= 500 mg daily, quinacrine \<= 100 mg daily\];
  * and/or prednisone (or prednisone-equivalent) (\<= 20 mg daily);
  * and/or no more than 1 of the following: azathioprine (\<= 150 mg daily), 6-mercaptopurine (\<= 150 mg daily), mycophenolate mofetil (\<= 2 g daily), mycophenolate sodium \<= 1,440 mg/day, leflunomide (\<= 20 mg daily), cyclosporine, tacrolimus, voclosporin (\<= 23.7 mg twice daily), methotrexate (\<= 25 mg weekly), or mizoribine (\<= 150 mg daily).

Exclusion Criteria:

* Class III/IV lupus nephritis that was treated with induction therapy within the 6 months prior to Screening.
* Active neuropsychiatric SLE (excluding lupus headache) within the 6 months prior to Screening.
* SLE overlap syndromes including, but not limited to, rheumatoid arthritis, systemic sclerosis, polymyositis, dermatomyositis, or mixed connective tissue disease (Sjögren's syndrome is permitted).
* Antiphospholipid syndrome and prior unprovoked venous or arterial thrombosis who are not on stable and adequate anticoagulation.
* Two or more episodes of herpes zoster, or one or more episodes of disseminated herpes zoster or herpes zoster ophthalmicus.
* History of malignancy, except for successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix.
* Pregnancy, breastfeeding, or considering becoming pregnant during the study.
* Clinically relevant or significant ECG abnormalities at Screening.
* Planned elective surgery that would impact study procedures or assessments through the completion of the Week 52 assessments.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants Achieving British Isles Lupus Assessment Group Based Combined Lupus Assessment (BICLA) Response
timeFrame: At Week 52
Secondary outcomes:
measure: Percentage of Flares Participants Experiencing Over Time.
timeFrame: Week 52
measure: Percentage of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI) -4
timeFrame: At Week 52
measure: Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS)
timeFrame: At Week 52
measure: Time to First Flare per SELENA SLEDAI Flare Index (SFI)
timeFrame: Week 52
measure: Percentage of Participants Achieving Oral Glucocorticoid Dose <=7.5 mg/day Prednisone-Equivalent
timeFrame: From Week 44 to Week 52
measure: Percentage of Participants Achieving >= 50% Improvement in Tender or Swollen Joints
timeFrame: Week 52
measure: Percentage of Participants Achieving >= 50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score
timeFrame: Week 52
measure: Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Version 4
timeFrame: Baseline to Week 52
measure: Change from Baseline in Lupus Pain Numerical Rating Scale (NRS)
timeFrame: At Week 52
measure: Change from Baseline in 36-Item Short Form Health Survey (SF-36) Acute Physical Component Summary (PCS)
timeFrame: Baseline to Week 52
Other outcomes:
Locations:
city: Chandler
country: United States
facility: AZ Arthritis and Rheumatology /ID# 261848
state: Arizona
city: Flagstaff
country: United States
facility: AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 254767
state: Arizona
city: Gilbert
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC /ID# 252820
state: Arizona
city: Glendale
country: United States
facility: Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 252824
state: Arizona
city: Mesa
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC /ID# 261845
state: Arizona
city: Peoria
country: United States
facility: Arizona Arthritis & Rheumatology Research /ID# 273555
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 252831
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC /ID# 252825
state: Arizona
city: Scottsdale
country: United States
facility: HonorHealth Rheumatology /ID# 261953
state: Arizona
city: Tucson
country: United States
facility: Arizona Arthritis & Rheumatology Associates - Tucson /ID# 252828
state: Arizona
city: Jonesboro
country: United States
facility: Arthritis and Rheumatism Associates /ID# 253033
state: Arkansas
city: Anaheim
country: United States
facility: Kaiser Permanente Lakeview Medical Offices /ID# 253906
state: California
city: Beverly Hills
country: United States
facility: David S. Hallegua MD, A Professional Corporation /ID# 253902
state: California
city: Beverly Hills
country: United States
facility: Wallace Rheumatic Studies Center, LLC /ID# 252806
state: California
city: Chula Vista
country: United States
facility: Advanced Clinical Research Center, LLC dba TriWest Research Associates /ID# 272870
state: California
city: Fullerton
country: United States
facility: Providence - St. Jude Medical Center /ID# 252822
state: California
city: Hemet
country: United States
facility: Private Practice - Dr. Chandrakant V. Mehta /ID# 275100
state: California
city: Huntington Beach
country: United States
facility: Newport Huntington Medical Group /ID# 252827
state: California
city: La Jolla
country: United States
facility: Moores Cancer Center at UC San Diego /ID# 253903
state: California
city: La Palma
country: United States
facility: Arthritis & Osteo Medical Ctr /ID# 252812
state: California
city: Los Angeles
country: United States
facility: Wagdy Kades, M.D., Inc /ID# 272065
state: California
city: Santa Monica
country: United States
facility: Providence St. John's Health Center /ID# 253905
state: California
city: Thousand Oaks
country: United States
facility: Millennium Clinical Trials /ID# 252817
state: California
city: Thousand Oaks
country: United States
facility: Cohen Medical Centers /ID# 268524
state: California
city: Tustin
country: United States
facility: Solace Research /ID# 275198
state: California
city: Upland
country: United States
facility: Upland Rheumatology Center /ID# 268623
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital /ID# 253184
state: Colorado
city: Denver
country: United States
facility: Denver Arthritis Clinic /ID# 253189
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine /ID# 254567
state: Connecticut
city: Aventura
country: United States
facility: Arthritis and Rheumatic Disease Specialties /ID# 253624
state: Florida
city: Avon Park
country: United States
facility: HARAC Research Corp. /ID# 254922
state: Florida
city: Boca Raton
country: United States
facility: Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 253623
state: Florida
city: Brandon
country: United States
facility: Bay Area Arthritis and Osteo /ID# 253597
state: Florida
city: Cooper City
country: United States
facility: GNP Consultants, dba, GNP Research /ID# 272868
state: Florida
city: Coral Springs
country: United States
facility: Duplicate_Believe Clinical Trials /ID# 255427
state: Florida
city: Daytona Beach
country: United States
facility: International Medical Research /ID# 253617
state: Florida
city: DeBary
country: United States
facility: Omega Research Debary, LLC /ID# 254939
state: Florida
city: Gainesville
country: United States
facility: University of Florida /ID# 261984
state: Florida
city: Greenacres City
country: United States
facility: Finlay Medical Research - Greenacres /ID# 274902
state: Florida
city: Hialeah
country: United States
facility: Evolution Research Center /ID# 272991
state: Florida
city: Hialeah
country: United States
facility: Neoclinical Research /ID# 253614
state: Florida
city: Hollywood
country: United States
facility: South Florida Rheumatology /ID# 268525
state: Florida
city: Jacksonville
country: United States
facility: Encore Research Group-Jacksonville Center for Clinical Research /ID# 257272
state: Florida
city: Jacksonville
country: United States
facility: UF Health Rheumatology /ID# 255351
state: Florida
city: Margate
country: United States
facility: Life Clinical Trials /ID# 253615
state: Florida
city: Miami
country: United States
facility: Lakes Research, LLC /ID# 253621
state: Florida
city: Miami
country: United States
facility: University of Miami, Division of Rheumatology /ID# 261594
state: Florida
city: Orlando
country: United States
facility: HMD Research LLC /ID# 253595
state: Florida
city: Orlando
country: United States
facility: University of Central Florida /ID# 261112
state: Florida
city: Ormond Beach
country: United States
facility: Millennium Research /ID# 253600
state: Florida
city: Palm Beach Gardens
country: United States
facility: Vitalia Research /ID# 272642
state: Florida
city: Plantation
country: United States
facility: IRIS Research and Development, LLC /ID# 253618
state: Florida
city: Saint Petersburg
country: United States
facility: BayCare Medical Group /ID# 253593
state: Florida
city: Tampa
country: United States
facility: Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 253602
state: Florida
city: Tampa
country: United States
facility: Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 253899
state: Florida
city: Tampa
country: United States
facility: Baycare Medical Group - Tampa /ID# 255135
state: Florida
city: Atlanta
country: United States
facility: Emory University School Of Medicine - Atlanta /ID# 261529
state: Georgia
city: Kennesaw
country: United States
facility: Trinity Research Centers /ID# 262039
state: Georgia
city: Marietta
country: United States
facility: Atlanta Research Center for Rheumatology /ID# 253610
state: Georgia
city: Chicago
country: United States
facility: University of Illinois at Chicago /ID# 263014
state: Illinois
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine /ID# 264090
state: Illinois
city: Chicago
country: United States
facility: Next Innovative Clinical Research - Chicago /ID# 268739
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medical Center, Duchossois Center for Advanced Medicin /ID# 263162
state: Illinois
city: Libertyville
country: United States
facility: Deerbrook Medical Associates /ID# 253029
state: Illinois
city: Orland Park
country: United States
facility: Advanced Quality Medical Research /ID# 254983
state: Illinois
city: Rockford
country: United States
facility: OrthoIllinois /ID# 253188
state: Illinois
city: Schaumburg
country: United States
facility: Greater Chicago Specialty Physicians /ID# 253021
state: Illinois
city: Skokie
country: United States
facility: Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 253020
state: Illinois
city: Skokie
country: United States
facility: NorthShore University HealthSystem - Skokie /ID# 254568
state: Illinois
city: Willowbrook
country: United States
facility: Willow Rheumatology and Wellness, PLLC /ID# 253018
state: Illinois
city: Hopkinsville
country: United States
facility: Western KY Rheumatology /ID# 254937
state: Kentucky
city: Lake Charles
country: United States
facility: Accurate Clinical Research /ID# 272647
state: Louisiana
city: Shreveport
country: United States
facility: Willis Knighton /ID# 256343
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland, Baltimore /ID# 262556
state: Maryland
city: Worcester
country: United States
facility: UMass Memorial Medical Center /ID# 262742
state: Massachusetts
city: Clinton Township
country: United States
facility: Clinical Research Institute Of Michigan /ID# 273051
state: Michigan
city: Grand Blanc
country: United States
facility: AA Medical Research Center - Grand Blanc /ID# 253028
state: Michigan
city: Lansing
country: United States
facility: June DO, PC /ID# 253030
state: Michigan
city: Kansas City
country: United States
facility: Kansas City Physician Partners /ID# 254786
state: Missouri
city: Kalispell
country: United States
facility: Logan Health Research - Glacier View Research Institute - Rheumatology /ID# 252808
state: Montana
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center - 1 Medical Center Drive /ID# 254923
state: New Hampshire
city: Las Cruces
country: United States
facility: Arthritis and Osteoporosis Associates of New Mexico /ID# 252818
state: New Mexico
city: Bronx
country: United States
facility: Urban Health Plan /ID# 268059
state: New York
city: Brooklyn
country: United States
facility: Joseph S. and Diane H. Steinberg Ambulatory Care Center /ID# 253592
state: New York
city: New York
country: United States
facility: NYU Langone Orthopedic Center /ID# 253613
state: New York
city: Potsdam
country: United States
facility: St. Lawrence Health System /ID# 253598
state: New York
city: Charlotte
country: United States
facility: Joint And Muscle Research Institute /ID# 272845
state: North Carolina
city: Charlotte
country: United States
facility: DJL Clinical Research, PLLC /ID# 253620
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Medical Group /ID# 256328
state: North Carolina
city: Salisbury
country: United States
facility: Accellacare - Salisbury /ID# 253608
state: North Carolina
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist Medical Center /ID# 254125
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center /ID# 259174
state: Ohio
city: Middleburg Heights
country: United States
facility: Paramount Medical Research and Consulting /ID# 253016
state: Ohio
city: Perrysburg
country: United States
facility: Clinical Research Source, Inc. /ID# 253027
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Medical Research Foundation /ID# 263509
state: Oklahoma
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia, LLC /ID# 254156
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center /ID# 256661
state: Pennsylvania
city: Summerville
country: United States
facility: Low Country Rheumatology /ID# 272956
state: South Carolina
city: Jackson
country: United States
facility: West Tennessee Research Institute /ID# 252807
state: Tennessee
city: Memphis
country: United States
facility: Shelby Research /ID# 256937
state: Tennessee
city: Allen
country: United States
facility: Arthritis and Rheumatology Research Institute, PLLC /ID# 253014
state: Texas
city: Corpus Christi
country: United States
facility: Arthritis Care of Texas /ID# 261719
state: Texas
city: Fort Worth
country: United States
facility: JPS Rheumatology Clinic /ID# 253185
state: Texas
city: Fort Worth
country: United States
facility: Arthiritis and Rheumatology Specialists PA /ID# 255950
state: Texas
city: Harlingen
country: United States
facility: Integrative Rheumatology of South Texas /ID# 261977
state: Texas
city: Katy
country: United States
facility: R & H Clinical Research - 777 Katy /ID# 254126
state: Texas
city: Katy
country: United States
facility: Biopharma Informatic /ID# 273651
state: Texas
city: McAllen
country: United States
facility: Valley Arthritis Center /ID# 253022
state: Texas
city: Plano
country: United States
facility: Trinity Universal Research Associates, Inc /ID# 253013
state: Texas
city: Red Oak
country: United States
facility: Epic Medical Research /ID# 255326
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute /ID# 255832
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc /ID# 254949
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research - Tomball /ID# 255134
state: Texas
city: Roanoke
country: United States
facility: Carilion Clinic /ID# 253374
state: Virginia
city: Beckley
country: United States
facility: Rheumatology & Pulmonary Clinic /ID# 273561
state: West Virginia
city: Milwaukee
country: United States
facility: Wisconsin Medical Center /ID# 256660
state: Wisconsin
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 254278
state: Buenos Aires
city: Quilmes
country: Argentina
facility: CER Instituto Medico /ID# 255302
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Organizacion Medica de Investigacion (OMI) /ID# 254281
state: Ciudad Autonoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Fundacion CIDEA /ID# 254279
state: Ciudad Autonoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Sanatorio Guemes /ID# 254283
state: Ciudad Autonoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Instituto Medico Especializado /ID# 255281
state: Ciudad Autonoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Aprillus Asistencia e Investigacion /ID# 254276
state: Ciudad Autonoma De Buenos Aires
city: Rosario
country: Argentina
facility: Instituto CAICI S.R.L /ID# 254280
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Centro de Investigaciones Medicas Tucuman /ID# 254274
state: Tucuman
city: Botany
country: Australia
facility: Emeritus Research Sydney /ID# 256249
state: New South Wales
city: Concord
country: Australia
facility: Concord Repatriation General Hospital /ID# 257945
state: New South Wales
city: Darlinghurst
country: Australia
facility: Momentum Clinical Research /ID# 253542
state: New South Wales
city: Tiwi
country: Australia
facility: Royal Darwin Hospital /ID# 263160
state: Northern Territory
city: Woodville
country: Australia
facility: The Queen Elizabeth Hospital /ID# 253826
state: South Australia
city: Camberwell
country: Australia
facility: Emeritus Research /ID# 256800
state: Victoria
city: Clayton
country: Australia
facility: Monash Health - Monash Medical Centre /ID# 255678
state: Victoria
city: Victoria Park
country: Australia
facility: Colin Bayliss Research and Teaching Unit /ID# 261077
state: Western Australia
city: Merksem
country: Belgium
facility: ZAS Palfijn /ID# 252802
state: Antwerpen
city: Anderlecht
country: Belgium
facility: Universite Libre de Bruxelles - Hopital Erasme /ID# 261997
state: Bruxelles-Capitale
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel /ID# 269065
state: Bruxelles-Capitale
city: Banja Luka
country: Bosnia and Herzegovina
facility: Institute of Physical Medicine,Rehab. and Orthopedic Surgery Dr.Miroslav Zotovic /ID# 262588
state: Republika Srpska
city: Banja Luka
country: Bosnia and Herzegovina
facility: Klinicki centar Banja Luka /ID# 253581
state: Republika Srpska
city: Banja Luka
country: Bosnia and Herzegovina
facility: Klinicki centar Banja Luka /ID# 253582
state: Republika Srpska
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinical Center University of Sarajevo /ID# 253583
city: Sarajevo
country: Bosnia and Herzegovina
facility: Polyclinic Srce Sarajeva /ID# 255475
city: Salvador
country: Brazil
facility: SER - Servicos Especializados em Reumatologia da Bahia /ID# 253354
state: Bahia
city: Vitoria
country: Brazil
facility: CEDOES - Centro de Diagnóstico e Pesquisa da Osteoporose do Espírito Santo /ID# 254588
state: Espirito Santo
city: Juiz de Fora
country: Brazil
facility: CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 253346
state: Minas Gerais
city: Curitiba
country: Brazil
facility: EDUMED Educacao em Saude S/S LTDA /ID# 253274
state: Parana
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre /ID# 253357
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: LMK Sevicos Medicos S/S /ID# 253353
state: Rio Grande Do Sul
city: Sao Jose Do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 261024
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Hospital do Rim /ID# 253983
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 254316
city: Sofiya
country: Bulgaria
facility: Mc Excelsior /ID# 272499
state: Sofia
city: Sofiya
country: Bulgaria
facility: Medical Center Academy /ID# 253322
state: Sofia
city: Plovdiv
country: Bulgaria
facility: Umbal Kaspela /ID# 252645
city: Plovdiv
country: Bulgaria
facility: Medical Center Artmed Ltd /Id# 254572
city: Plovdiv
country: Bulgaria
facility: Medical center Unimed /ID# 253324
city: Ruse
country: Bulgaria
facility: Medical center Teodora /ID# 252646
city: Sofia
country: Bulgaria
facility: Military Medical Academy Multiprofile Hospital /ID# 252644
city: Sofiya
country: Bulgaria
facility: Diagnostic consultative center Focus-5 /ID# 252642
city: Sofiya
country: Bulgaria
facility: Diagnostic consultative center Focus-5 /ID# 252643
city: Calgary
country: Canada
facility: University of Calgary /ID# 259515
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital /ID# 259516
state: Alberta
city: Winnipeg
country: Canada
facility: University of Manitoba /ID# 259517
state: Manitoba
city: Toronto
country: Canada
facility: Toronto Western Hospital /ID# 254017
state: Ontario
city: Sherbrooke
country: Canada
facility: CIUSSS de l'Estrie - CHUS /ID# 254716
state: Quebec
city: Victoria
country: Chile
facility: Servicio de Salud Araucanía Norte Hospital Victoria /ID# 255179
state: Araucania
city: Concepción
country: Chile
facility: Hospital Guillermo Grant Benavente de Concepción /ID# 254841
state: Bio-Bio
city: Las Condes
country: Chile
facility: Inmunocel /Id# 256390
state: Region Metropolitana De Santiago
city: Santiago
country: Chile
facility: Centro Internacional de Estudios Clinicos - CIEC /ID# 254838
state: Region Metropolitana Santiago
city: Providencia
country: Chile
facility: Investigaciones Medicas Limitada /Id# 254842
city: Bengbu
country: China
facility: The first affiliated hospital of bengbu medical college /ID# 252853
state: Anhui
city: Beijing
country: China
facility: China-Japan Friendship Hospital /ID# 253048
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital /ID# 253138
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 253045
state: Beijing
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University /ID# 252630
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital /ID# 252920
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University /ID# 252921
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 253137
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital Of Guangzhou Medical University /ID# 252927
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital, Sun Yat-Sen University /ID# 252923
state: Guangdong
city: Shantou
country: China
facility: The First Affiliated Hospital of Shantou University Medical College /ID# 253426
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital Of Guangxi Medical University /ID# 272798
state: Guangxi
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 252963
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College of HUST /ID# 252632
state: Hubei
city: Zhuzhou
country: China
facility: Zhuzhou Central Hospital /ID# 252962
state: Hunan
city: Huhehaote
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University /ID# 252629
state: Inner Mongolia
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou /ID# 252992
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital /ID# 253042
state: Jiangsu
city: Nantong
country: China
facility: Affiliated hospital of nantong university /ID# 252991
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital /ID# 253858
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Central Hospital /ID# 252922
state: Jiangsu
city: Yancheng
country: China
facility: Yancheng First People's Hospital /ID# 254599
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital /ID# 252945
state: Jiangsu
city: Jiujiang
country: China
facility: The First People's Hospital of Jiujiang /ID# 252989
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital /ID# 252940
state: Jiangxi
city: Pingxiang
country: China
facility: Jiangxi Pingxiang People's Hospital /ID# 252919
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University /ID# 252771
state: Jilin
city: Xi'an
country: China
facility: Second Affiliated Hospital of Xian Jiaotong University /ID# 252861
state: Shaanxi
city: Jining
country: China
facility: Jining No.1 People's Hospital /ID# 252897
state: Shandong
city: Linyi
country: China
facility: Linyi People's Hospital /ID# 252898
state: Shandong
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 263435
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University /ID# 252854
state: Sichuan
city: Mianyang
country: China
facility: Mianyang Central Hospital /ID# 272850
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital /ID# 252868
state: Tianjin
city: Urumqi
country: China
facility: People's Hospital of Xinjiang Uygur Autonomous Region /ID# 266897
state: Xinjiang
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University /ID# 252925
state: Yunnan
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 252633
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital /ID# 253860
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University /ID# 253649
state: Zhejiang
city: Medellín
country: Colombia
facility: IPS Suramericana SAS - IPS Sura San Diego /ID# 261536
state: Antioquia
city: Medellín
country: Colombia
facility: Hospital Pablo Tobón Uribe /ID# 254101
state: Antioquia
city: Bogotá
country: Colombia
facility: Centro de Investigacion en Reumatologia y especialidades Medicas S.A.S- CIREEM /ID# 254097
state: Cundinamarca
city: Zipaquirá
country: Colombia
facility: Healthy Medical Center S.A.S /ID# 254098
state: Cundinamarca
city: Bucaramanga
country: Colombia
facility: Fundacion Oftalmologica de Santander - FOSCAL /ID# 254100
state: Santander
city: Barranquilla
country: Colombia
facility: Clinica de la Costa S.A.S /ID# 260727
city: Zagreb
country: Croatia
facility: Poliklinika Bonifarm /ID# 252846
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Poliklinika Solmed /ID# 252965
state: Grad Zagreb
city: Osijek
country: Croatia
facility: Klinicki bolnicki centar Osijek /ID# 252847
state: Osjecko-baranjska Zupanija
city: Rijeka
country: Croatia
facility: Klinicki bolnicki centar Rijeka /ID# 252848
state: Primorsko-goranska Zupanija
city: Split
country: Croatia
facility: Klinicki Bolnicki Centar (KBC) Split /ID# 252849
state: Splitsko-dalmatinska Zupanija
city: Zadar
country: Croatia
facility: Opća Bolnica Zadar /ID# 272415
state: Zadarska Zupanija
city: Tallinn
country: Estonia
facility: Innomedica /ID# 253722
state: Harjumaa
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital - Magdaleena Unit /ID# 253721
state: Harjumaa
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation /ID# 253723
state: Harjumaa
city: Tartu
country: Estonia
facility: MediTrials /ID# 253720
state: Tartumaa
city: Toulouse
country: France
facility: CHU Toulouse - Hopital Rangueil /ID# 254148
state: Haute-Garonne
city: Paris Cedex 13
country: France
facility: Hopital Pitie Salpetriere /ID# 253009
state: Ile-de-France
city: Lyon
country: France
facility: HCL - Hopital de la Croix-Rousse /ID# 254147
state: Rhone
city: Cologne
country: Germany
facility: Krankenhaus Porz am Rhein /ID# 254373
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Universitaetsmedizin Mainz /ID# 260735
state: Rheinland-Pfalz
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden /ID# 270832
state: Sachsen
city: Berlin-buch
country: Germany
facility: Immanuel Krankenhaus Berlin /ID# 253389
city: Frankfurt am Main
country: Germany
facility: Fraunhofer Institute for Translational Medicine & Pharmacology ITMP /ID# 253734
city: Athens
country: Greece
facility: General Hospital of Athens Laiko /ID# 252952
state: Attiki
city: Athens
country: Greece
facility: University General Hospital Attikon /ID# 253209
state: Attiki
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion PA.G.N.I /ID# 252951
state: Kriti
city: Guatemala
country: Guatemala
facility: Clinica Medica Especializada en Medicina Interna y Reumatologia /ID# 261156
city: Guatemala
country: Guatemala
facility: Clinica Medica Reumatologica /ID# 255009
city: Guatemala
country: Guatemala
facility: Clinica Especializada en Medicina Interna /ID# 255006
city: Guatemala
country: Guatemala
facility: Clínica Médica Especializada en Medicina Interna y Reumatologia /ID# 257248
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 254552
state: Baranya
city: Veszprém
country: Hungary
facility: Vital Medical Center /ID# 252876
state: Fejer
city: Debrecen
country: Hungary
facility: Debreceni Egyetem-Klinikai Kozpont /ID# 252877
state: Hajdu-Bihar
city: Székesfehérvár
country: Hungary
facility: Vita Verum Medical Bt. /ID# 273579
state: Szekesfehervar
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 252886
city: Haifa
country: Israel
facility: The Lady Davis Carmel Medical Center /ID# 253303
state: H_efa
city: Kfar Saba
country: Israel
facility: Meir Medical Center /ID# 254187
state: HaMerkaz
city: Nahariya
country: Israel
facility: Galilee Medical Center /ID# 252859
state: HaTsafon
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 252857
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 252858
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Hebrew University /ID# 252654
state: Yerushalayim
city: Rome
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini /ID# 253680
state: Roma
city: Rome
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 254288
state: Roma
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria delle Marche /ID# 254138
city: Padova
country: Italy
facility: Azienda Ospedale-Universita Padova /ID# 253704
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana /ID# 254289
city: Kitakyushu-shi
country: Japan
facility: Hospital of the University of Occupational and Environmental Health, Japan /ID# 253269
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital /ID# 253306
state: Hokkaido
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital /ID# 253267
state: Miyagi
city: Miyazaki-shi
country: Japan
facility: University of Miyazaki Hospital /ID# 253416
state: Miyazaki
city: Okayama-shi
country: Japan
facility: Okayama University Hospital /ID# 253821
state: Okayama
city: Naha-shi
country: Japan
facility: Shinkenko Clinic /ID# 253271
state: Okinawa
city: Kawagoe
country: Japan
facility: Saitama Medical Center /ID# 253263
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Institute of Science Tokyo Hospital /ID# 254430
state: Tokyo
city: Chuo-shi
country: Japan
facility: University of Yamanashi Hospital /ID# 253264
state: Yamanashi
city: Chiba
country: Japan
facility: National Hospital Org Chiba Medical Center Chibahigashi National Hospital /ID# 253268
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital /ID# 273658
city: Cheonan-si
country: Korea, Republic of
facility: SoonChunHyang University Hospital Cheonan /ID# 254777
state: Chungcheongnamdo
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Bitgoeul Hospital /ID# 254675
state: Gwangju Gwang Yeogsi
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital /ID# 252955
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 254022
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Marys Hospital /ID# 252958
state: Seoul Teugbyeolsi
city: Rīga
country: Latvia
facility: Riga East Clinical University Hospital /ID# 253751
state: Riga
city: Adazi
country: Latvia
facility: M & M Centrs LTD /ID# 253752
city: Daugavpils
country: Latvia
facility: Daugavpils Regional Hospital /ID# 253754
city: Liepaja
country: Latvia
facility: Dr. Saulites-Kandevicas PP in Cardiology and Rheumatology /ID# 273246
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital /ID# 253750
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 253755
city: Klaipeda
country: Lithuania
facility: Republic Klaipeda Hospital /ID# 253759
city: Klaipeda
country: Lithuania
facility: Klaipeda University Hospital, Klaipeda Hospital /ID# 253757
city: Vilnius
country: Lithuania
facility: Inlita - Santara KTC /ID# 253758
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos /ID# 253756
city: Papatoetoe
country: New Zealand
facility: Aotearoa Clinical Trials /ID# 253555
state: Auckland
city: Takapuna
country: New Zealand
facility: North Shore Hospital /ID# 253554
state: Auckland
city: Bydgoszcz
country: Poland
facility: MICS Centrum Medyczne Bydgoszcz /ID# 253281
state: Kujawsko-pomorskie
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 253233
state: Kujawsko-pomorskie
city: Warsaw
country: Poland
facility: MICS Centrum Medyczne Warszawa /ID# 253273
state: Mazowieckie
city: Olsztyn
country: Poland
facility: ETYKA-Osrodek Badan Klinicznych /ID# 252967
state: Warminsko-mazurskie
city: Poznan
country: Poland
facility: Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 252964
state: Wielkopolskie
city: Guilhufe
country: Portugal
facility: Centro Hospitalar do Tamega e Sousa - Hospital Padre Americo /ID# 252911
state: Porto
city: Almada
country: Portugal
facility: Hospital Garcia de Orta /ID# 252903
state: Setubal
city: Ponte de Lima
country: Portugal
facility: Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 252902
state: Viana Do Castelo
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 252899
city: Bayamon
country: Puerto Rico
facility: Clinical Research Investigator Group, LLC /ID# 259170
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico /ID# 256352
city: San Juan
country: Puerto Rico
facility: GCM Medical Group PSC /ID# 253039
city: San Juan
country: Puerto Rico
facility: Caribbean Medical Research Center /ID# 254882
city: San Juan
country: Puerto Rico
facility: Mindful Medical Research /ID# 253040
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 252904
state: Cluj
city: Brasov
country: Romania
facility: Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL /ID# 253207
city: Bucuresti
country: Romania
facility: Spitalul Clinic Sf. Maria /ID# 252905
city: Belgrade
country: Serbia
facility: Institute for Rheumatology /ID# 253172
state: Beograd
city: Belgrade
country: Serbia
facility: Institute for Rheumatology /ID# 253173
state: Beograd
city: Belgrade
country: Serbia
facility: Institute for Rheumatology /ID# 253174
state: Beograd
city: Belgrade
country: Serbia
facility: Institute for Rheumatology /ID# 253175
state: Beograd
city: Belgrade
country: Serbia
facility: Military Medical Academy /ID# 264235
state: Beograd
city: Belgrade
country: Serbia
facility: Clin Hosp Ctr Bezanijska Kosa /ID# 253179
state: Beograd
city: Zrenjanin
country: Serbia
facility: General Hospital Djordje Joanovic /ID# 253177
state: Vojvodina
city: Novi Sad
country: Serbia
facility: University Clinical Center Vojvodina /ID# 253176
city: Kosice
country: Slovakia
facility: ARTROMAC n.o. /ID# 253056
state: Kosicky Kraj
city: Piešťany
country: Slovakia
facility: Narodny Ustav Reumatickych Chorob Piestany /ID# 273341
state: Trnavsky Kraj
city: Martin
country: Slovakia
facility: MEDMAN s.r.o. /ID# 252950
state: Zilinsky Kraj
city: Košice II
country: Slovakia
facility: ZAZABIE s. r .o. /ID# 255793
city: Piestany
country: Slovakia
facility: Thermium s.r.o. /ID# 260839
city: Johannesburg
country: South Africa
facility: Wits Clinical Research /ID# 252931
state: Gauteng
city: Pretoria
country: South Africa
facility: University of Pretoria /ID# 252932
state: Gauteng
city: Pretoria
country: South Africa
facility: Dr Elsa van Duuren /ID# 254218
state: Gauteng
city: Umhlanga
country: South Africa
facility: Dr Asokan Naidoo /ID# 253351
state: Kwazulu-Natal
city: Cape Town
country: South Africa
facility: Winelands Medical Research - Somerset West /ID# 254614
state: Western Cape
city: Cape Town
country: South Africa
facility: Arthritis Clinical Research Trials /ID# 253349
state: Western Cape
city: Stellenbosch
country: South Africa
facility: Winelands Medical Research Centre /ID# 252934
state: Western Cape
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña /ID# 253123
state: A Coruna
city: Vigo
country: Spain
facility: Hospital Meixoeiro (CHUVI) /ID# 253124
state: Pontevedra
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Valme /ID# 253121
city: Basel Town
country: Switzerland
facility: Universitätsspital Basel /ID# 252907
state: Basel-Stadt
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen /ID# 252906
state: Sankt Gallen
city: Bern
country: Switzerland
facility: Inselspital, Universitaetsspital Bern /ID# 252909
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 252937
state: Taipei
city: Keelung
country: Taiwan
facility: Chang Gung Mem Hosp Keelung /ID# 253636
city: Taichung
country: Taiwan
facility: China Medical University Hospital /ID# 252936
city: Sihhiye, Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fak /ID# 253266
state: Ankara
city: Yenimahalle
country: Turkey
facility: Gazi Universitesi Tip Fakultes /ID# 252843
state: Ankara
city: Şehitkamil
country: Turkey
facility: Sanko Universitesi Hastanesi /ID# 252841
state: Gaziantep
city: Antalya
country: Turkey
facility: Akdeniz Universitesi Tip Fakul /ID# 252839
city: Istanbul
country: Turkey
facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 252844
city: Meram Konya
country: Turkey
facility: Necmettin Erbakan Universitesi /ID# 252837
city: Trabzon
country: Turkey
facility: Karadeniz Technical University Farabi Hospital /ID# 252845
city: Bretton
country: United Kingdom
facility: North West Anglia NHS Foundation Trust /ID# 254590
state: Cambridgeshire
city: London
country: United Kingdom
facility: Guy's Hospital /ID# 252978
state: Greater London
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust /ID# 252982
state: Hampshire
city: Northampton
country: United Kingdom
facility: Northampton General Hospital NHS Trust /ID# 254813
state: Northamptonshire
city: Londonderry
country: United Kingdom
facility: Western Health and Social Care Trust /ID# 254592
state: Northern Ireland
city: Luton
country: United Kingdom
facility: Luton and Dunstable Hospital NHS Foundation Trust /ID# 255323
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals University NHS Trust /ID# 252986
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: