Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus (SELECT-SLE)

April 24, 2026 updated by: AbbVie

SELECT-SLE: A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Moderately to Severely Active SLE

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1014

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, 1426
        • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 254278
      • Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, 1180
        • Fundación Sanatorio Guemes /ID# 254283
      • La Plata, Buenos Aires, Argentina, 1900
        • Hospital Italiano La Plata /ID# 254284
      • Quilmes, Buenos Aires, Argentina, 1878
        • CER Instituto Medico /ID# 255302
    • Buenos Aires F.D.
      • Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1015
        • Organizacion Medica de Investigacion (OMI) /ID# 254281
      • Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1121
        • Fundacion CIDEA /ID# 254279
      • Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1405
        • Instituto Medico Especializado /ID# 255281
      • Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1958
        • Aprillus Asistencia e Investigacion /ID# 254276
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Instituto CAICI S.R.L /ID# 254280
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Centro de Investigaciones Medicas Tucuman /ID# 254274
  • Australia
    • New South Wales
      • Botany, New South Wales, Australia, 2019
        • Emeritus Research Sydney /ID# 256249
      • Concord, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital /ID# 257945
      • Darlinghurst, New South Wales, Australia, 2010
        • Momentum Clinical Research /ID# 253542
    • Northern Territory
      • Tiwi, Northern Territory, Australia, 0811
        • Royal Darwin Hospital /ID# 263160
    • South Australia
      • Woodville, South Australia, Australia, 5011
        • The Queen Elizabeth Hospital /ID# 253826
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • Emeritus Research /ID# 256800
      • Clayton, Victoria, Australia, 3168
        • Monash Health - Monash Medical Centre /ID# 255678
    • Western Australia
      • Victoria Park, Western Australia, Australia, 6100
        • Colin Bayliss Research and Teaching Unit /ID# 261077
  • Belgium
    • Antwerpen
      • Merksem, Antwerpen, Belgium, 2170
        • ZAS Palfijn /ID# 252802
    • Brussels Capital
      • Anderlecht, Brussels Capital, Belgium, 1070
        • Universite Libre de Bruxelles - Hopital Erasme /ID# 261997
      • Jette, Brussels Capital, Belgium, 1090
        • Universitair Ziekenhuis Brussel /ID# 269065
  • Bosnia and Herzegovina
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Clinical Center University of Sarajevo /ID# 253583
      • Sarajevo, Bosnia and Herzegovina, 71210
        • Polyclinic Srce Sarajeva /ID# 255475
    • Republika Srpska
      • Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
        • University Clinical Centre of the Republic of Srpska /ID# 253581
      • Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
        • University Clinical Centre of the Republic of Srpska /ID# 253582
      • Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
        • Institute of Physical Medicine,Rehab. and Orthopedic Surgery Dr.Miroslav Zotovic /ID# 262588
  • Brazil
      • São Paulo, Brazil, 04038-002
        • Hospital do Rim /ID# 253983
      • São Paulo, Brazil, 05403-000
        • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 254316
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29055-450
        • CEDOES - Centro de Diagnóstico e Pesquisa da Osteoporose do Espírito Santo /ID# 254588
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40150-150
        • SER - Servicos Especializados em Reumatologia da Bahia /ID# 253354
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brazil, 36010-570
        • CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 253346
    • Paraná
      • Curitiba, Paraná, Brazil, 80440-210
        • Nossa Saude Pesquisa Ltda. /ID# 253274
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre /ID# 253357
      • Porto Alegre, Rio Grande do Sul, Brazil, 90480-000
        • LMK Sevicos Medicos S/S /ID# 253353
    • São Paulo
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 261024
  • Bulgaria
      • Plovdiv, Bulgaria, 4023
        • Medical center Unimed /ID# 253324
      • Plovdiv, Bulgaria, 4001
        • Umbal Kaspela /ID# 252645
      • Plovdiv, Bulgaria, 4002
        • Medical Center Artmed Ltd /Id# 254572
      • Rousse, Bulgaria, 7012
        • Medical center Teodora /ID# 252646
      • Sofia, Bulgaria, 1606
        • Military Medical Academy Multiprofile Hospital /ID# 252644
      • Sofia, Bulgaria, 1612
        • Medical Center Academy /ID# 253322
    • Sofia
      • Sofiya, Sofia, Bulgaria, 1407
        • Mc Excelsior /ID# 272499
      • Sofiya, Sofia, Bulgaria, 1463
        • Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 252642
      • Sofiya, Sofia, Bulgaria, 1463
        • Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 252643
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary /ID# 259515
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital /ID# 259516
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M4
        • University of Manitoba /ID# 259517
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital /ID# 254017
    • Quebec
      • Sherbrooke, Quebec, Canada, J1G 2E8
        • CIUSSS de l'Estrie - CHUS /ID# 254716
  • Chile
      • Providencia, Chile, 7500710
        • Investigaciones Medicas Limitada /Id# 254842
    • Araucania
      • Victoria, Araucania, Chile, 4720000
        • Servicio de Salud Araucanía Norte Hospital Victoria /ID# 255179
    • Biobio
      • Concepción, Biobio, Chile, 4070038
        • Hospital Guillermo Grant Benavente de Concepción /ID# 254841
    • Region Metropolitana Santiago
      • Santiago, Region Metropolitana Santiago, Chile, 8420383
        • Centro Internacional de Estudios Clinicos - CIEC /ID# 254838
    • Santiago Metropolitan
      • Las Condes, Santiago Metropolitan, Chile, 7580206
        • Inmunocel /Id# 256390
  • China
    • Anhui
      • Bengbu, Anhui, China, 233004
        • The first affiliated hospital of bengbu medical college /ID# 252853
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100029
        • China-Japan Friendship Hospital /ID# 253048
      • Beijing, Beijing Municipality, China, 100191
        • Peking University Third Hospital /ID# 253138
      • Beijing, Beijing Municipality, China, 100730
        • Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 253045
    • Fujian
      • Xiamen, Fujian, China, 361003
        • The First Affiliated Hospital of Xiamen University /ID# 252630
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital, Sun Yat-sen University /ID# 252921
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 253137
      • Guangzhou, Guangdong, China, 510163
        • The First Affiliated Hospital Of Guangzhou Medical University /ID# 252927
      • Guangzhou, Guangdong, China, 510630
        • The Third Affiliated Hospital, Sun Yat-Sen University /ID# 252923
      • Guangzhou, Guangdong, China, 510080
        • Guangdong Provincial Peoples Hospital /ID# 252920
      • Shantou, Guangdong, China, 515041
        • The First Affiliated Hospital of Shantou University Medical College /ID# 253426
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • The First Affiliated Hospital Of Guangxi Medical University /ID# 272798
    • Henan
      • Luoyang, Henan, China, 471003
        • The First Affiliated Hospital Of Henan University Of Science &Technology /ID# 272929
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 252963
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital Tongji Medical College of HUST /ID# 252632
    • Hunan
      • Zhuzhou, Hunan, China, 412007
        • Zhuzhou Central Hospital /ID# 252962
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 010050
        • The Affiliated Hospital of Inner Mongolia Medical University /ID# 252629
    • Jiangsu
      • Changzhou, Jiangsu, China, 213003
        • The First People's Hospital of Changzhou /ID# 252992
      • Nanjing, Jiangsu, China, 210008
        • Nanjing Drum Tower Hospital /ID# 253042
      • Nantong, Jiangsu, China, 226001
        • Affiliated hospital of nantong university /ID# 252991
      • Wuxi, Jiangsu, China, 214023
        • Wuxi People's Hospital /ID# 253858
      • Xuzhou, Jiangsu, China, 221009
        • Xuzhou Central Hospital /ID# 252922
      • Yancheng, Jiangsu, China, 224001
        • Yancheng First People's Hospital /ID# 254599
      • Yangzhou, Jiangsu, China, 225001
        • Northern Jiangsu People's Hospital /ID# 252945
    • Jiangxi
      • Jiujiang, Jiangxi, China, 332000
        • The First People's Hospital of Jiujiang /ID# 252989
      • Nanchang, Jiangxi, China, 330006
        • Jiangxi Provincial People's Hospital /ID# 252940
      • Pingxiang, Jiangxi, China, 337055
        • Jiangxi Pingxiang Peoples Hospital /ID# 252919
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University /ID# 252771
    • Shaanxi
      • Xi'an, Shaanxi, China, 710004
        • Second Affiliated Hospital of Xian Jiaotong University /ID# 252861
    • Shandong
      • Jining, Shandong, China, 272001
        • Jining No.1 People's Hospital /ID# 252897
      • Linyi, Shandong, China, 276034
        • Linyi People's Hospital /ID# 252898
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200001
        • Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 263435
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University /ID# 252854
      • Mianyang, Sichuan, China, 621000
        • Mianyang Central Hospital /ID# 272850
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300052
        • Tianjin Medical University General Hospital /ID# 252868
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830001
        • People's Hospital of Xinjiang Uygur Autonomous Region /ID# 266897
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • First Affiliated Hospital of Kunming Medical University /ID# 252925
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 252633
      • Hangzhou, Zhejiang, China, 310014
        • Zhejiang Provincial People's Hospital /ID# 253860
      • Wenzhou, Zhejiang, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical University /ID# 253649
  • Colombia
      • Barranquilla, Colombia, 080020
        • Clinica de la Costa S.A.S /ID# 260727
    • Antioquia
      • Medellín, Antioquia, Colombia, 050016
        • IPS Suramericana SAS - IPS Sura San Diego /ID# 261536
      • Medellín, Antioquia, Colombia, 050034
        • Hospital Pablo Tobón Uribe /ID# 254101
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia, 110221
        • Centro de Investigacion en Reumatologia y especialidades Medicas S.A.S- CIREEM /ID# 254097
      • Zipaquirá, Cundinamarca, Colombia, 250252
        • Healthy Medical Center S.A.S /ID# 254098
    • Santander Department
      • Bucaramanga, Santander Department, Colombia, 681004
        • Fundacion Oftalmologica de Santander - FOSCAL /ID# 254100
  • Croatia
    • City of Zagreb
      • Zagreb, City of Zagreb, Croatia, 10000
        • Poliklinika Bonifarm /ID# 252846
      • Zagreb, City of Zagreb, Croatia, 10000
        • Poliklinika Solmed /ID# 252965
    • County of Osijek-Baranja
      • Osijek, County of Osijek-Baranja, Croatia, 31000
        • Klinicki bolnicki centar Osijek /ID# 252847
    • Primorje-Gorski Kotar County
      • Rijeka, Primorje-Gorski Kotar County, Croatia, 51000
        • Klinicki bolnicki centar Rijeka /ID# 252848
    • Split-Dalmatia County
      • Split, Split-Dalmatia County, Croatia, 21000
        • Klinicki Bolnicki Centar (KBC) Split /ID# 252849
    • Zadar County
      • Zadar, Zadar County, Croatia, 23000
        • Opća Bolnica Zadar /ID# 272415
  • Estonia
    • Harju
      • Tallinn, Harju, Estonia, 10117
        • Innomedica /ID# 253722
      • Tallinn, Harju, Estonia, 11312
        • East Tallinn Central Hospital - Magdaleena Unit /ID# 253721
      • Tallinn, Harju, Estonia, 13419
        • North Estonia Medical Centre Foundation /ID# 253723
    • Tartu
      • Tartu, Tartu, Estonia, 50708
        • MediTrials /ID# 253720
  • France
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31400
        • CHU Toulouse - Hopital Rangueil /ID# 254148
    • Rhone
      • Lyon, Rhone, France, 69004
        • HCL - Hopital de la Croix-Rousse /ID# 254147
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75013
        • Hopital Pitie Salpetriere /ID# 253009
  • Germany
      • Buch, Germany, 13125
        • Immanuel Krankenhaus Berlin /ID# 253389
      • Frankfurt am Main, Germany, 60596
        • Fraunhofer Institute for Translational Medicine & Pharmacology ITMP /ID# 253734
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 51149
        • Krankenhaus Porz am Rhein /ID# 254373
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Universitaetsmedizin Mainz /ID# 260735
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 270832
  • Greece
    • Attica
      • Athens, Attica, Greece, 11527
        • General Hospital of Athens Laiko /ID# 252952
      • Athens, Attica, Greece, 12462
        • University General Hospital Attikon /ID# 253209
    • Crete
      • Heraklion, Crete, Greece, 71500
        • University General Hospital of Heraklion PA.G.N.I /ID# 252951
  • Guatemala
      • Guatemala City, Guatemala, 01010
        • Clinica Medica Especializada en Medicina Interna y Reumatologia /ID# 261156
      • Guatemala City, Guatemala, 01010
        • Clinica Medica Reumatologica /ID# 255009
      • Guatemala City, Guatemala, 01011
        • Clinica Especializada en Medicina Interna /ID# 255006
      • Guatemala City, Guatemala, zona 10
        • Clínica Médica Especializada en Medicina Interna y Reumatologia /ID# 257248
  • Hungary
      • Gyula, Hungary, 5700
        • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 252886
    • Baranya
      • Pécs, Baranya, Hungary, 7624
        • Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 254552
    • Fejér
      • Veszprém, Fejér, Hungary, 8200
        • Vital-Medicina Kft. /ID# 252876
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • Debreceni Egyetem-Klinikai Kozpont /ID# 252877
    • Szekesfehervar
      • Székesfehérvár, Szekesfehervar, Hungary, 8000
        • Vita Verum Medical Bt. /ID# 273579
  • Israel
      • Haifa, Israel, 34362
        • The Lady Davis Carmel Medical Center /ID# 253303
    • Central District
      • Kfar Saba, Central District, Israel, 4428164
        • Meir Medical Center /ID# 254187
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 91120
        • Hadassah Medical Center-Hebrew University /ID# 252654
    • Northern District
      • Nahariya, Northern District, Israel, 2210001
        • Galilee Medical Center /ID# 252859
    • Tel Aviv
      • Ramat Gan, Tel Aviv, Israel, 5265601
        • The Chaim Sheba Medical Center /ID# 252857
      • Tel Aviv, Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center /ID# 252858
  • Italy
      • Ancona, Italy, 60020
        • Azienda Ospedaliero Universitaria delle Marche /ID# 254138
      • Padova, Italy, 35128
        • Azienda Ospedale-Universita Padova /ID# 253704
      • Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana /ID# 254289
    • Roma
      • Rome, Roma, Italy, 00149
        • Azienda Ospedaliera San Camillo Forlanini /ID# 253680
      • Rome, Roma, Italy, 00161
        • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 254288
  • Japan
      • Chiba, Japan, 260-8712
        • National Hospital Org Chiba Medical Center Chibahigashi National Hospital /ID# 253268
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital /ID# 273658
    • Fukuoka
      • Kitakyushu-shi, Fukuoka, Japan, 807-8556
        • Hospital Of The University Of Occupational And Environmental Health, Japan /ID# 253269
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital /ID# 253306
    • Miyagi
      • Sendai, Miyagi, Japan, 9808574
        • Tohoku University Hospital /ID# 253267
    • Miyazaki
      • Miyazaki, Miyazaki, Japan, 889-1692
        • University of Miyazaki Hospital /ID# 253416
    • Okayama-ken
      • Okayama, Okayama-ken, Japan, 700-8558
        • Okayama University Hospital /ID# 253821
    • Okinawa
      • Naha, Okinawa, Japan, 900-0015
        • Shinkenko Clinic /ID# 253271
    • Saitama
      • Kawagoe, Saitama, Japan, 350-8550
        • Saitama Medical Center /ID# 253263
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Institute of Science Tokyo Hospital /ID# 254430
    • Yamanashi
      • Chuo-shi, Yamanashi, Japan, 409-3898
        • University of Yamanashi Hospital /ID# 253264
  • Latvia
      • Adazi, Latvia, LV-2164
        • M & M Centrs LTD /ID# 253752
      • Daugavpils, Latvia, LV-5401
        • Daugavpils Regional Hospital /ID# 253754
      • Liepāja, Latvia, LV-3401
        • Dr. Saulites-Kandevicas PP in Cardiology and Rheumatology /ID# 273246
      • Riga, Latvia, LV-1002
        • Pauls Stradins Clinical University Hospital /ID# 253750
    • Riga
      • Riga, Riga, Latvia, 1038
        • Riga East Clinical University Hospital /ID# 253751
  • Lithuania
      • Kaunas, Lithuania, 50161
        • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 253755
      • Klaipėda, Lithuania, 92253
        • Republic Klaipeda Hospital /ID# 253759
      • Klaipėda, Lithuania, 92288
        • Klaipeda University Hospital, Klaipeda Hospital /ID# 253757
      • Vilnius, Lithuania, 08661
        • Vilnius University Hospital Santaros Klinikos /ID# 253756
      • Vilnius, Lithuania, 08406
        • Inlita - Santara KTC /ID# 253758
  • Mexico
    • Coahuila
      • Torreón, Coahuila, Mexico, 27000
        • Centro de Investigacion Medica Dr. Alberto Bazzoni CIMAB S.A de C.V. /ID# 261462
    • Guanajuato
      • León, Guanajuato, Mexico, 37000
        • Morales Vargas Centro de Investigacion S.C. /ID# 254661
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 253966
      • Guadalajara, Jalisco, Mexico, 44657
        • Grupo Clinico Catei Sociedad Civil /Id# 257700
    • Mexico City
      • Mexico City, Mexico City, Mexico, 06090
        • Hospital de Jesus /ID# 255146
      • Mexico City, Mexico City, Mexico, 11850
        • CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 253965
    • Yucatán
      • Mérida, Yucatán, Mexico, 97070
        • Medical Care & Research SA de CV /ID# 260825
  • New Zealand
    • Auckland
      • Papatoetoe, Auckland, New Zealand, 2025
        • Aotearoa Clinical Trials /ID# 253555
      • Takapuna, Auckland, New Zealand, 0622
        • North Shore Hospital /ID# 253554
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 61-545
        • Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 252964
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-065
        • MICS Centrum Medyczne Bydgoszcz /ID# 253281
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-168
        • Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 253233
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 00-874
        • MICS Centrum Medyczne Warszawa /ID# 253273
    • Warmian-Masurian Voivodeship
      • Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-117
        • ETYKA-Osrodek Badan Klinicznych /ID# 252967
  • Portugal
      • Porto, Portugal, 4099-001
        • Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 252899
    • Porto District
      • Guilhufe, Porto District, Portugal, 4560-136
        • Centro Hospitalar do Tamega e Sousa - Hospital Padre Americo /ID# 252911
    • Setúbal District
      • Almada, Setúbal District, Portugal, 2805-267
        • Hospital Garcia de Orta /ID# 252903
    • Viana do Castelo District
      • Ponte de Lima, Viana do Castelo District, Portugal, 4990-041
        • Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 252902
  • Puerto Rico
      • Bayamón, Puerto Rico, 00960
        • Clinical Research Investigator Group /ID# 259170
      • San Juan, Puerto Rico, 00918-3756
        • Mindful Medical Research /ID# 253040
      • San Juan, Puerto Rico, 00909-1711
        • Clinical Research Puerto Rico /ID# 256352
      • San Juan, Puerto Rico, 00917-3104
        • GCM Medical Group /ID# 253039
      • San Juan, Puerto Rico, 00918-3501
        • CMRC Headlands LLC /ID# 254882
  • Romania
      • Brasov, Romania, 500283
        • Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL /ID# 253207
      • Bucharest, Romania, 011172
        • Spitalul Clinic Sf. Maria /ID# 252905
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400006
        • Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 252904
  • Serbia
      • Novi Sad, Serbia, 21000
        • University Clinical Center Vojvodina /ID# 253176
    • Beograd
      • Belgrade, Beograd, Serbia, 11000
        • Institute for Rheumatology /ID# 253172
      • Belgrade, Beograd, Serbia, 11000
        • Institute for Rheumatology /ID# 253173
      • Belgrade, Beograd, Serbia, 11000
        • Institute for Rheumatology /ID# 253174
      • Belgrade, Beograd, Serbia, 11000
        • Institute for Rheumatology /ID# 253175
      • Belgrade, Beograd, Serbia, 11080
        • Clin Hosp Ctr Bezanijska Kosa /ID# 253179
      • Belgrade, Beograd, Serbia, 11000
        • Military Medical Academy /ID# 264235
    • Vojvodina
      • Zrenjanin, Vojvodina, Serbia, 23000
        • General Hospital Djordje Joanovic /ID# 253177
  • Slovakia
      • Košice II, Slovakia, 040 11
        • ZAZABIE s. r .o. /ID# 255793
      • Piešťany, Slovakia, 921 01
        • Thermium s.r.o. /ID# 260839
    • Košice Region
      • Košice, Košice Region, Slovakia, 040 11
        • ARTROMAC n.o. /ID# 253056
    • Trnava Region
      • Piešťany, Trnava Region, Slovakia, 921 12
        • Narodny Ustav Reumatickych Chorob Piestany /ID# 273341
    • Žilina Region
      • Martin, Žilina Region, Slovakia, 036 01
        • MEDMAN s.r.o. /ID# 252950
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1864
        • Wits Clinical Research /ID# 252931
      • Pretoria, Gauteng, South Africa, 0001
        • University of Pretoria /ID# 252932
      • Pretoria, Gauteng, South Africa, 0002
        • Dr Elsa van Duuren /ID# 254218
    • KwaZulu-Natal
      • Umhlanga, KwaZulu-Natal, South Africa, 4319
        • Dr Asokan Naidoo /ID# 253351
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7130
        • Winelands Medical Research - Somerset West /ID# 254614
      • Cape Town, Western Cape, South Africa, 7405
        • Arthritis Clinical Research Trials /ID# 253349
      • Stellenbosch, Western Cape, South Africa, 7600
        • Winelands Medical Research Centre /ID# 252934
  • South Korea
    • Chungcheongnam-do
      • Cheonan-si, Chungcheongnam-do, South Korea, 31151
        • SoonChunHyang University Hospital Cheonan /ID# 254777
    • Gwangju Gwang Yeogsi
      • Gwangju, Gwangju Gwang Yeogsi, South Korea, 61748
        • Chonnam National University Bitgoeul Hospital /ID# 254675
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 04763
        • Hanyang University Seoul Hospital /ID# 252955
      • Seoul, Seoul Teugbyeolsi, South Korea, 05505
        • Asan Medical Center /ID# 254022
      • Seoul, Seoul Teugbyeolsi, South Korea, 06591
        • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 252958
  • Spain
      • Seville, Spain, 41014
        • Hospital Universitario Virgen de Valme /ID# 253121
    • A Coruna
      • A Coruña, A Coruna, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña /ID# 253123
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36213
        • Hospital Meixoeiro (CHUVI) /ID# 253124
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital, Universitaetsspital Bern /ID# 252909
    • Canton of Basel-City
      • Basel Town, Canton of Basel-City, Switzerland, 4031
        • University Hospital Basel /ID# 252907
    • Canton of St. Gallen
      • Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen /ID# 252906
  • Taiwan
      • Keelung, Taiwan, 204
        • Chang Gung Mem Hosp Keelung /ID# 253636
      • Taichung, Taiwan, 40447
        • China Medical University Hospital /ID# 252936
    • Taipei
      • Taipei City, Taipei, Taiwan, 100
        • National Taiwan University Hospital /ID# 252937
  • Turkey (Türkiye)
      • Antalya, Turkey (Türkiye), 07059
        • Akdeniz Universitesi Tip Fakul /ID# 252839
      • Istanbul, Turkey (Türkiye), 34480
        • Basaksehir Cam ve Sakura Sehir Hastanesi /ID# 253557
      • Istanbul, Turkey (Türkiye), 34899
        • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 252844
      • Meram Konya, Turkey (Türkiye), 42080
        • Necmettin Erbakan Universitesi /ID# 252837
      • Trabzon, Turkey (Türkiye), 61080
        • Karadeniz Technical University Farabi Hospital /ID# 252845
    • Ankara
      • Sihhiye, Ankara, Ankara, Turkey (Türkiye), 06100
        • Hacettepe Universitesi Tip Fak /ID# 253266
      • Yenimahalle, Ankara, Turkey (Türkiye), 06560
        • Gazi Universitesi Tip Fakultes /ID# 252843
    • Gaziantep
      • Şehitkamil, Gaziantep, Turkey (Türkiye), 27090
        • Sanko Universitesi Hastanesi /ID# 252841
  • United Kingdom
      • Luton, United Kingdom, LU4 0DZ
        • Luton and Dunstable Hospital NHS Foundation Trust /ID# 255323
      • Portsmouth, United Kingdom, PO6 3LY
        • Portsmouth Hospitals University NHS Trust /ID# 252986
    • Cambridgeshire
      • Bretton, Cambridgeshire, United Kingdom, PE3 9GZ
        • North West Anglia NHS Foundation Trust /ID# 254590
    • Greater London
      • London, Greater London, United Kingdom, SE1 9RT
        • Guy's Hospital /ID# 252978
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • University Hospital Southampton NHS Foundation Trust /ID# 252982
    • Northamptonshire
      • Northampton, Northamptonshire, United Kingdom, NN1 5BD
        • Northampton General Hospital NHS Trust /ID# 254813
    • Northern Ireland
      • Londonderry, Northern Ireland, United Kingdom, BT47 6SB
        • Western Health and Social Care Trust /ID# 254592
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85225-2906
        • AZ Arthritis and Rheumatology /ID# 261848
      • Flagstaff, Arizona, United States, 86001-6299
        • AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 254767
      • Gilbert, Arizona, United States, 85297-7336
        • Arizona Arthritis & Rheumatology Research, PLLC /ID# 252820
      • Glendale, Arizona, United States, 85306-9802
        • Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 252824
      • Mesa, Arizona, United States, 85210-6871
        • Arizona Arthritis & Rheumatology Research, PLLC /ID# 261845
      • Peoria, Arizona, United States, 85381
        • Arizona Arthritis & Rheumatology Research /ID# 273555
      • Phoenix, Arizona, United States, 85037
        • Arizona Arthritis & Rheumatology Research, PLLC /ID# 252825
      • Phoenix, Arizona, United States, 85032
        • Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 252831
      • Scottsdale, Arizona, United States, 85258-4668
        • HonorHealth Rheumatology /ID# 261953
      • Tucson, Arizona, United States, 85704
        • Arizona Arthritis & Rheumatology Associates - Tucson /ID# 252828
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401-6251
        • Arthritis and Rheumatism Associates /ID# 253033
    • California
      • Anaheim, California, United States, 92807-3028
        • Kaiser Permanente Lakeview Medical Offices /ID# 253906
      • Beverly Hills, California, United States, 90211
        • David S. Hallegua MD, A Professional Corporation /ID# 253902
      • Beverly Hills, California, United States, 90211
        • Wallace Rheumatic Studies Center, LLC /ID# 252806
      • Beverly Hills, California, United States, 90211
        • Wallace and Lee Center /ID# 275129
      • Chula Vista, California, United States, 91910
        • Advanced Clinical Research Center, LLC dba TriWest Research Associates /ID# 272870
      • Fullerton, California, United States, 92835
        • Providence - St. Jude Medical Center /ID# 252822
      • Hemet, California, United States, 92543
        • Private Practice - Dr. Chandrakant V. Mehta /ID# 275100
      • Huntington Beach, California, United States, 92648-5994
        • Newport Huntington Medical Group /ID# 252827
      • La Jolla, California, United States, 92093
        • Moores Cancer Center at UC San Diego /ID# 253903
      • La Palma, California, United States, 90623-1728
        • Arthritis & Osteo Medical Ctr /ID# 252812
      • Los Angeles, California, United States, 90017
        • Wagdy Kades, M.D., Inc /ID# 272065
      • Santa Monica, California, United States, 90404-2303
        • Providence St. Johns Health Center /ID# 253905
      • Thousand Oaks, California, United States, 91360-3951
        • Millennium Clinical Trials /ID# 252817
      • Thousand Oaks, California, United States, 91360
        • Cohen Medical Centers /ID# 268524
      • Tustin, California, United States, 92780
        • Solace Research /ID# 275198
      • Upland, California, United States, 91786
        • Upland Rheumatology Center /ID# 268623
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital /ID# 253184
      • Denver, Colorado, United States, 80230
        • Denver Arthritis Clinic /ID# 253189
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine /ID# 254567
    • Florida
      • Aventura, Florida, United States, 33180
        • Arthritis and Rheumatic Disease Specialties /ID# 253624
      • Avon Park, Florida, United States, 33825-2958
        • HARAC Research Corp. /ID# 254922
      • Boca Raton, Florida, United States, 33486
        • Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 253623
      • Boynton Beach, Florida, United States, 33426
        • Mdr Core Network, Inc /Id# 276704
      • Brandon, Florida, United States, 33511
        • Bay Area Arthritis and Osteo /ID# 253597
      • Cooper City, Florida, United States, 33024
        • GNP Consultants, dba, GNP Research /ID# 272868
      • Coral Springs, Florida, United States, 33065
        • Duplicate_Believe Clinical Trials /ID# 255427
      • Daytona Beach, Florida, United States, 32117
        • International Medical Research /ID# 253617
      • DeBary, Florida, United States, 32713-2260
        • Omega Research Debary, LLC /ID# 254939
      • Gainesville, Florida, United States, 32610-3008
        • University of Florida /ID# 261984
      • Greenacres City, Florida, United States, 33467
        • Finlay Medical Research - Greenacres /ID# 274902
      • Hialeah, Florida, United States, 33012
        • Evolution Research Center /ID# 272991
      • Hialeah, Florida, United States, 33016-1897
        • Neoclinical Research /ID# 253614
      • Hollywood, Florida, United States, 33026
        • South Florida Rheumatology /ID# 268525
      • Jacksonville, Florida, United States, 32256
        • UF Health Rheumatology /ID# 255351
      • Jacksonville, Florida, United States, 32216
        • Encore Research Group-Jacksonville Center for Clinical Research /ID# 257272
      • Margate, Florida, United States, 33063
        • Life Clinical Trials /ID# 253615
      • Miami, Florida, United States, 33014
        • Lakes Research, LLC /ID# 253621
      • Miami, Florida, United States, 33136-2107
        • University of Miami, Division of Rheumatology /ID# 261594
      • Miami, Florida, United States, 33175
        • Ezy Medical Research /ID# 276221
      • Orlando, Florida, United States, 32819
        • HMD Research LLC /ID# 253595
      • Orlando, Florida, United States, 32827-7664
        • University of Central Florida /ID# 261112
      • Ormond Beach, Florida, United States, 32174
        • Millennium Research /ID# 253600
      • Palm Beach Gardens, Florida, United States, 33410
        • Vitalia Research /ID# 272642
      • Plant City, Florida, United States, 33563
        • Believe Clinical Trials /ID# 277004
      • Plantation, Florida, United States, 33324
        • IRIS Research and Development, LLC /ID# 253618
      • St. Petersburg, Florida, United States, 33705
        • BayCare Medical Group /ID# 253593
      • Tampa, Florida, United States, 33606
        • Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 253602
      • Tampa, Florida, United States, 33606
        • Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 253899
      • Tampa, Florida, United States, 33614
        • Baycare Medical Group - Tampa /ID# 255135
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University School Of Medicine - Atlanta /ID# 261529
      • Kennesaw, Georgia, United States, 30144-1762
        • Trinity Research Centers /ID# 262039
      • Marietta, Georgia, United States, 30060
        • Atlanta Research Center For Rheumatology - Marietta /ID# 253610
      • Roswell, Georgia, United States, 30076
        • Arthritis and Rheumatology Center PC /ID# 275994
      • Suwanee, Georgia, United States, 30024-7290
        • Immunology and Rheumatology Research Associates LLC /ID# 267582
    • Illinois
      • Chicago, Illinois, United States, 60607
        • University of Illinois Hospital and Health Sciences System /ID# 263014
      • Chicago, Illinois, United States, 60611-2927
        • Northwestern University Feinberg School of Medicine /ID# 264090
      • Chicago, Illinois, United States, 60616
        • Next Innovative Clinical Research - Chicago /ID# 268739
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center /ID# 263162
      • Morton, Illinois, United States, 60053
        • Illinois Bone & Joint Institute - Morton /ID# 274455
      • Orland Park, Illinois, United States, 60462
        • Advanced Quality Medical Research /ID# 254983
      • Rockford, Illinois, United States, 61114-4937
        • OrthoIllinois /ID# 253188
      • Schaumburg, Illinois, United States, 60195-3106
        • Greater Chicago Specialty Physicians /ID# 253021
      • Skokie, Illinois, United States, 60076
        • Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 253020
      • Skokie, Illinois, United States, 60077
        • NorthShore University HealthSystem - Skokie /ID# 254568
      • Vernon Hills, Illinois, United States, 60061
        • Deerbrook Medical Associates /ID# 253029
      • Willowbrook, Illinois, United States, 60527
        • Willow Rheumatology and Wellness, PLLC /ID# 253018
    • Kentucky
      • Hopkinsville, Kentucky, United States, 42240
        • Western KY Rheumatology /ID# 254937
    • Louisiana
      • Lake Charles, Louisiana, United States, 70605
        • Accurate Clinical Research (SMO/Network/Consortium) /ID# 272647
      • Shreveport, Louisiana, United States, 71103-3920
        • Willis Knighton /ID# 256343
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Baltimore /ID# 262556
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • UMass Memorial Medical Center /ID# 262742
    • Michigan
      • Clinton Township, Michigan, United States, 48038
        • Clinical Research Institute Of Michigan /ID# 273051
      • Grand Blanc, Michigan, United States, 48439
        • AA Medical Research Center - Grand Blanc /ID# 253028
      • Lansing, Michigan, United States, 48911
        • June DO, PC /ID# 253030
    • Missouri
      • Kansas City, Missouri, United States, 64151
        • Kansas City Physician Partners /ID# 254786
    • Montana
      • Kalispell, Montana, United States, 59901
        • Logan Health Research - Glacier View Research Institute - Rheumatology /ID# 252808
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center /ID# 254923
    • New Mexico
      • Las Cruces, New Mexico, United States, 88011
        • Arthritis and Osteoporosis Associates of New Mexico /ID# 252818
      • Santa Fe, New Mexico, United States, 87505
        • Inspire Santa Fe Medical Group /ID# 275947
    • New York
      • Brooklyn, New York, United States, 11201-5501
        • Joseph S. and Diane H. Steinberg Ambulatory Care Center /ID# 253592
      • New York, New York, United States, 10016-2772
        • NYU Langone Orthopedic Center /ID# 253613
      • Potsdam, New York, United States, 13676
        • St. Lawrence Health System /ID# 253598
      • The Bronx, New York, United States, 10459
        • Urban Health Plan /ID# 268059
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • DJL Clinical Research, PLLC /ID# 253620
      • Charlotte, North Carolina, United States, 28204
        • Joint And Muscle Research Institute /ID# 272845
      • Raleigh, North Carolina, United States, 27609
        • Raleigh Medical Group /ID# 256328
      • Salisbury, North Carolina, United States, 28144-2735
        • Accellacare - Salisbury /ID# 253608
      • Winston-Salem, North Carolina, United States, 27157
        • Atrium Health Wake Forest Baptist Medical Center /ID# 254125
    • Ohio
      • Cincinnati, Ohio, United States, 45219-2364
        • University of Cincinnati Medical Center /ID# 259174
      • Middleburg Heights, Ohio, United States, 44130
        • Paramount Medical Research and Consulting /ID# 253016
      • Perrysburg, Ohio, United States, 43551
        • Clinical Research Source, Inc. /ID# 253027
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma Medical Research Foundation /ID# 263509
      • Oklahoma City, Oklahoma, United States, 73116-7226
        • Rheumatology Associates of Oklahoma /ID# 253012
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
        • Clinical Research of Philadelphia, LLC /ID# 254156
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Medical Center /ID# 256661
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center /ID# 263686
    • South Carolina
      • Summerville, South Carolina, United States, 29486
        • Low Country Rheumatology /ID# 272956
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • West Tennessee Research Institute /ID# 252807
      • Memphis, Tennessee, United States, 38119
        • Shelby Research /ID# 256937
    • Texas
      • Allen, Texas, United States, 75013-6147
        • Arthritis and Rheumatology Research Institute, PLLC /ID# 253014
      • Arlington, Texas, United States, 76012
        • Rheumatology Associates /ID# 276066
      • Corpus Christi, Texas, United States, 78415-1800
        • Arthritis Care of Texas /ID# 261719
      • El Paso, Texas, United States, 79902
        • Texas Arthritis Center /ID# 277049
      • Fort Worth, Texas, United States, 76104-4917
        • JPS Rheumatology Clinic /ID# 253185
      • Fort Worth, Texas, United States, 76177
        • Arthiritis and Rheumatology Specialists PA /ID# 255950
      • Harlingen, Texas, United States, 78550
        • Integrative Rheumatology of South Texas - Harlingen /ID# 261977
      • Houston, Texas, United States, 77089-6142
        • Accurate Clinical Research - Houston /ID# 276220
      • Katy, Texas, United States, 77449
        • Accurate Clinical Research Katy /ID# 276459
      • Katy, Texas, United States, 77450-2244
        • R & H Clinical Research - Katy /ID# 254126
      • Katy, Texas, United States, 77494
        • Biopharma Informatic /ID# 273651
      • McAllen, Texas, United States, 78501-1401
        • Valley Arthritis Center /ID# 253022
      • Plano, Texas, United States, 75024
        • Texas Rheumatology Research Institute Llc /Id# 253013
      • Red Oak, Texas, United States, 75154
        • Epic Medical Research /ID# 255326
      • San Antonio, Texas, United States, 78215
        • Sun Research Institute /ID# 255832
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc /ID# 254949
      • San Marcos, Texas, United States, 78666
        • Epic Medical Research- San Marcos /ID# 278360
      • Sugar Land, Texas, United States, 77479
        • Fort Bend Rheumatology Associates, PLLC /ID# 268492
      • Tomball, Texas, United States, 77375
        • DM Clinical Research - Tomball /ID# 255134
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Carilion Roanoke Memorial Hospital /ID# 253374
    • West Virginia
      • Beckley, West Virginia, United States, 25801
        • Rheumatology & Pulmonary Clinic /ID# 273561
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Wisconsin Medical Center /ID# 256660

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study 1- Upadacitinib Dose A
Participants will receive upadacitinib dose A once daily for 52 weeks.
Drug: Upadacitinib
Oral Tablets
Other Names:
  • RINVOQ
Placebo Comparator: Study 1- Placebo
Participants will receive upadacitinib matching placebo once daily for 52 weeks.
Drug: Placebo
Oral Tablet
Experimental: Study 2- Upadacitinib Dose A
Participants will receive upadacitinib dose A once daily for 52 weeks.
Drug: Upadacitinib
Oral Tablets
Other Names:
  • RINVOQ
Placebo Comparator: Study 2- Placebo
Participants will receive upadacitinib matching placebo once daily for 52 weeks.
Drug: Placebo
Oral Tablet
Experimental: Study 3- Low Disease Activity Upadacitinib (LDA) Dose A
Participants in the upadacitinib arms from Study 1 or Study 2 with LDA will receive upadacitinib dose A once daily for 52 weeks.
Drug: Upadacitinib
Oral Tablets
Other Names:
  • RINVOQ
Experimental: Study 3- Low Disease Activity Upadacitinib Dose B
Participants in the upadacitinib arms from Study 1 or Study 2 with LDA will receive upadacitinib dose B once daily for 52 weeks.
Drug: Upadacitinib
Oral Tablets
Other Names:
  • RINVOQ
Experimental: Study 3- No LDA Upadacitinib Dose A
Participants in the upadacitinib arms from Study 1 or Study 2 with no LDA will receive upadacitinib dose A once daily for 52 weeks.
Drug: Upadacitinib
Oral Tablets
Other Names:
  • RINVOQ
Experimental: Study 3- Upadacitininb Dose A
Participants in the placebo arms of Study 1 or Study 2 will receive upadacitinib Dose A once daily for 52 weeks.
Drug: Upadacitinib
Oral Tablets
Other Names:
  • RINVOQ
Experimental: Study 3- Open Label Upadacitinib Dose A
Participants who experience a suspected systemic lupus erythematosus (SLE) flare may receive open label upadacitinib Dose A once daily for the remainder of the study.
Drug: Upadacitinib
Oral Tablets
Other Names:
  • RINVOQ
Experimental: Study 3- Open Label Upadacitinib Dose B
Participants who reach >= 65 years of age and are still on study drug may receive open-label upadacitinib Dose B once daily, and participants who experience a suspected SLE flare while on upadacitinib Dose B may receive upadacitinib Dose A for the remainder of the study.
Drug: Upadacitinib
Oral Tablets
Other Names:
  • RINVOQ
Experimental: Study 4- Upadacitinib Dose A
Participants receiving upadacitinib Dose A in Study 3 will continue on this dose once daily for 104 weeks.
Drug: Upadacitinib
Oral Tablets
Other Names:
  • RINVOQ
Experimental: Study 4- Upadacitinib Dose B
Participants receiving upadacitinib Dose B in Study 3 will continue on this dose once daily for 104 weeks.
Drug: Upadacitinib
Oral Tablets
Other Names:
  • RINVOQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving British Isles Lupus Assessment Group Based Combined Lupus Assessment (BICLA) Response
Time Frame: At Week 52
BICLA is a composite responder index based on improvement in organ systems without worsening of the overall condition and improvement in disease activity.
At Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI) -4
Time Frame: At Week 52
SRI is a composite responder index based on improvement in disease activity (number following SRI indicates numerical improvement in hSLEDAI score) without worsening of the overall condition (no worsening in Physician's Global Assessment (PhGA), < 0.3 point increase) or the development of significant disease activity in new organ systems (no new British Isles Lupus Assessment Group [BILAG] A or > 1 new BILAG B).
At Week 52
Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS)
Time Frame: At Week 52
LLDAS is a state of low disease activity based on SLEDAI score (hSLEDAI score <= 4 excluding hSLEDAI activity in major organ systems), absence of SLE disease activity in major organ systems and new disease activity, Physician's Global Assessment (PhGA <= 1), and concomitant medication usage.
At Week 52
Time to First Flare per SELENA SLEDAI Flare Index (SFI)
Time Frame: Week 52
SFI is an index defining SLE flares using changes in the hSLEDAI score, definitions of worsening signs and symptoms, treatment changes, and Physician's Global Assessment of Disease Activity.
Week 52
Percentage of Participants Achieving >= 50% Improvement in Tender or Swollen Joints
Time Frame: Week 52
Achievement of >= 50% improvement in tender or swollen joints among participants with >= 3 swollen joints and >= 6 total affected joints at Baseline.
Week 52
Percentage of Participants Achieving >= 50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score
Time Frame: Week 52
CLASI index used to assess cutaneous manifestations of SLE summarizing the activity of the disease. Scores range from 0 to 70, with higher scores indicating more severity. Achievement of >= 50% reduction in CLASI activity score among participants with baseline score >=10.
Week 52
Percentage of Participants Achieving Oral Glucocorticoid Dose <=7.5 mg/day Prednisone-Equivalent
Time Frame: From Week 44 to Week 52
Achievement of oral glucocorticoid dose <=7.5 mg/day prednisone-equivalent among participants taking >= 10 mg/day prednisone-equivalent at baseline.
From Week 44 to Week 52
Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Version 4
Time Frame: Baseline to Week 52
The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants. Participants respond to the questions on a scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue score ranges from 0 to 52, where higher scores represent less fatigue.
Baseline to Week 52
Change from Baseline in 36-Item Short Form Health Survey (SF-36) Acute Physical Component Summary (PCS)
Time Frame: Baseline to Week 52
The SF-36v2® Health Survey Acute is a general HRQoL instrument with extensive use in multiple disease states. The instrument comprises 36 total items (questions) targeting a participants's functional health and well-being in 8 dimensions (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Scoring is totaled into a Physical Component Summary and a Mental Component Summary. Higher scores indicate a better state of health.
Baseline to Week 52
Percentage of Flares Participants Experiencing Over Time.
Time Frame: Week 52
Flare is defined by the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) Systemic lupus erythematosus disease activity index (SLEDAI) Flare Index (SFI). An index defining Systemic lupus erythematosus (SLE) flares using changes in the Hybrid SLEDAI (hSLEDAI) score, definitions of worsening signs and symptoms, treatment changes, and Physician's Global Assessment of Disease Activity. Flare rate is number of flares per patient-year.
Week 52
Change from Baseline in Lupus Pain Numerical Rating Scale (NRS)
Time Frame: At Week 52
The Lupus Pain-NRS is a single-item questionnaire in which participants are asked to rate their overall pain level due to lupus over the last week. The Lupus Pain-NRS scores range from 0 to 10, with higher scores indicating a higher level of pain.
At Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

April 25, 2023

First Submitted That Met QC Criteria

April 25, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M23-699
  • 2023-503655-10-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

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.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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