Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus
- Registration Number
- NCT05843643
- Lead Sponsor
- AbbVie
- 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 3 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 based on their disease activity and their original treatment assignment in Study 1 or 2. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
-
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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Study 1- Placebo Placebo Participants will receive upadacitinib matching placebo once daily for 52 weeks. Study 2- Upadacitinib Dose A Upadacitinib Participants will receive upadacitinib dose A once daily for 52 weeks. Study 2- Placebo Placebo Participants will receive upadacitinib matching placebo once daily for 52 weeks. Study 3- Upadacitininb Dose A Upadacitinib Participants in the placebo arms of Study 1 or Study 2 will receive upadacitinib Dose A once daily for 52 weeks. Study 3- Low Disease Activity Upadacitinib (LDA) Dose A Upadacitinib Participants in the upadacitinib arms from Study 1 or Study 2 with LDA will receive upadacitinib dose A once daily for 52 weeks. Study 3- No LDA Upadacitinib Dose A Upadacitinib Participants in the upadacitinib arms from Study 1 or Study 2 with no LDA will receive upadacitinib dose A once daily for 52 weeks. Study 3- Open Label Upadacitinib Dose B Upadacitinib 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. Study 1- Upadacitinib Dose A Upadacitinib Participants will receive upadacitinib dose A once daily for 52 weeks. Study 3- Low Disease Activity Upadacitinib Dose B Upadacitinib Participants in the upadacitinib arms from Study 1 or Study 2 with LDA will receive upadacitinib dose B once daily for 52 weeks. Study 3- Open Label Upadacitinib Dose A Upadacitinib 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving British Isles Lupus Assessment Group Based Combined Lupus Assessment (BICLA) Response 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.
- Secondary Outcome Measures
Name Time Method Time to First Flare per SELENA SLEDAI Flare Index (SFI) 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.
Percentage of Participants Achieving Oral Glucocorticoid Dose <=7.5 mg/day Prednisone-Equivalent 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.
Percentage of Flares Participants Experiencing Over Time (Number of Flares Per Patient-Year) 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.
Percentage of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI) -4 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).
Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) 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.
Percentage of Participants Achieving >= 50% Improvement in Tender or Swollen Joints Week 52 Achievement of \>= 50% improvement in tender or swollen joints among participants with \>= 3 swollen joints and \>= 6 total affected joints at Baseline.
Percentage of Participants Achieving >= 50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score 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.
Change from Baseline in Lupus Pain Numerical Rating Scale (NRS) Baseline to 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.
Change from Baseline in 36-Item Short Form Health Survey (SF-36) Acute Physical Component Summary (PCS) 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.
Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Version 4 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.
Trial Locations
- Locations (294)
Universitair Ziekenhuis Brussel /ID# 269065
🇧🇪Jette, Bruxelles-Capitale, Belgium
AZ Arthritis and Rheumatology /ID# 261848
🇺🇸Chandler, Arizona, United States
AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 254767
🇺🇸Flagstaff, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC /ID# 252820
🇺🇸Gilbert, Arizona, United States
Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 252824
🇺🇸Glendale, Arizona, United States
Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 252831
🇺🇸Phoenix, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC /ID# 252825
🇺🇸Phoenix, Arizona, United States
HonorHealth Rheumatology /ID# 261953
🇺🇸Scottsdale, Arizona, United States
Arizona Arthritis & Rheumatology Associates - Tucson /ID# 252828
🇺🇸Tucson, Arizona, United States
Arthritis and Rheumatism Associates /ID# 253033
🇺🇸Jonesboro, Arkansas, United States
Kaiser Permanente Lakeview Medical Offices /ID# 253906
🇺🇸Anaheim, California, United States
David S. Hallegua MD, A Professional Corporation /ID# 253902
🇺🇸Beverly Hills, California, United States
Wallace Rheumatic Studies Center, LLC /ID# 252806
🇺🇸Beverly Hills, California, United States
Providence - St. Jude Medical Center /ID# 252822
🇺🇸Fullerton, California, United States
Newport Huntington Medical Group /ID# 252827
🇺🇸Huntington Beach, California, United States
Moores Cancer Center at UC San Diego /ID# 253903
🇺🇸La Jolla, California, United States
Arthritis & Osteo Medical Ctr /ID# 252812
🇺🇸La Palma, California, United States
Providence St. John's Health Center /ID# 253905
🇺🇸Santa Monica, California, United States
Millennium Clinical Trials /ID# 252817
🇺🇸Thousand Oaks, California, United States
Cohen Medical Centers /ID# 268524
🇺🇸Thousand Oaks, California, United States
Upland Rheumatology Center /ID# 268623
🇺🇸Upland, California, United States
Denver Arthritis Clinic /ID# 253189
🇺🇸Denver, Colorado, United States
Yale University School of Medicine /ID# 254567
🇺🇸New Haven, Connecticut, United States
Arthritis and Rheumatic Disease Specialties /ID# 253624
🇺🇸Aventura, Florida, United States
HARAC Research Corp. /ID# 254922
🇺🇸Avon Park, Florida, United States
Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 253623
🇺🇸Boca Raton, Florida, United States
Bay Area Arthritis and Osteo /ID# 253597
🇺🇸Brandon, Florida, United States
Believe Clinical Trials /ID# 255427
🇺🇸Coral Springs, Florida, United States
International Medical Research /ID# 253617
🇺🇸Daytona Beach, Florida, United States
Omega Research Debary, LLC /ID# 254939
🇺🇸DeBary, Florida, United States
University of Florida /ID# 261984
🇺🇸Gainesville, Florida, United States
Neoclinical Research /ID# 253614
🇺🇸Hialeah, Florida, United States
South Florida Rheumatology /ID# 268525
🇺🇸Hollywood, Florida, United States
Encore Research Group-Jacksonville Center for Clinical Research /ID# 257272
🇺🇸Jacksonville, Florida, United States
UF Health Rheumatology /ID# 255351
🇺🇸Jacksonville, Florida, United States
Life Clinical Trials /ID# 253615
🇺🇸Margate, Florida, United States
Lakes Research, LLC /ID# 253621
🇺🇸Miami, Florida, United States
University of Miami, Division of Rheumatology /ID# 261594
🇺🇸Miami, Florida, United States
HMD Research LLC /ID# 253595
🇺🇸Orlando, Florida, United States
University of Central Florida /ID# 261112
🇺🇸Orlando, Florida, United States
Millennium Research /ID# 253600
🇺🇸Ormond Beach, Florida, United States
IRIS Research and Development, LLC /ID# 253618
🇺🇸Plantation, Florida, United States
BayCare Medical Group /ID# 253593
🇺🇸Saint Petersburg, Florida, United States
Clinical Research of West Florida - Tampa /ID# 253602
🇺🇸Tampa, Florida, United States
Clinical Research of West Florida, Inc /ID# 253899
🇺🇸Tampa, Florida, United States
BayCare Medical Group, Inc. /ID# 255135
🇺🇸Tampa, Florida, United States
Emory University /ID# 261529
🇺🇸Atlanta, Georgia, United States
Trinity Research Centers /ID# 262039
🇺🇸Kennesaw, Georgia, United States
Atlanta Research Center for Rheumatology /ID# 253610
🇺🇸Marietta, Georgia, United States
Deerbrook Medical Associates /ID# 253029
🇺🇸Libertyville, Illinois, United States
Advanced Quality Medical Research /ID# 254983
🇺🇸Orland Park, Illinois, United States
OrthoIllinois /ID# 253188
🇺🇸Rockford, Illinois, United States
Greater Chicago Specialty Physicians /ID# 253021
🇺🇸Schaumburg, Illinois, United States
Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 253020
🇺🇸Skokie, Illinois, United States
NorthShore University HealthSystem - Skokie /ID# 254568
🇺🇸Skokie, Illinois, United States
Willow Rheumatology and Wellness, PLLC /ID# 253018
🇺🇸Willowbrook, Illinois, United States
Western KY Rheumatology /ID# 254937
🇺🇸Hopkinsville, Kentucky, United States
Willis Knighton /ID# 256343
🇺🇸Shreveport, Louisiana, United States
University of Maryland, Baltimore /ID# 262556
🇺🇸Baltimore, Maryland, United States
UMass Memorial Medical Center /ID# 262742
🇺🇸Worcester, Massachusetts, United States
AA Medical Research Center - Grand Blanc /ID# 253028
🇺🇸Grand Blanc, Michigan, United States
June DO, PC /ID# 253030
🇺🇸Lansing, Michigan, United States
Kansas City Physician Partners /ID# 254786
🇺🇸Kansas City, Missouri, United States
Logan Health Research /ID# 252808
🇺🇸Kalispell, Montana, United States
Dartmouth-Hitchcock Medical Center - 1 Medical Center Drive /ID# 254923
🇺🇸Lebanon, New Hampshire, United States
Arthritis and Osteoporosis Associates of New Mexico /ID# 252818
🇺🇸Las Cruces, New Mexico, United States
Joseph S. and Diane H. Steinberg Ambulatory Care Center /ID# 253592
🇺🇸Brooklyn, New York, United States
NYU Langone Orthopedic Center /ID# 253613
🇺🇸New York, New York, United States
St. Lawrence Health System /ID# 253598
🇺🇸Potsdam, New York, United States
DJL Clinical Research, PLLC /ID# 253620
🇺🇸Charlotte, North Carolina, United States
Raleigh Medical Group /ID# 256328
🇺🇸Raleigh, North Carolina, United States
Accellacare - Salisbury /ID# 253608
🇺🇸Salisbury, North Carolina, United States
Atrium Health Wake Forest Baptist Medical Center /ID# 254125
🇺🇸Winston-Salem, North Carolina, United States
University of Cincinnati Medical Center /ID# 259174
🇺🇸Cincinnati, Ohio, United States
Paramount Medical Research and Consulting /ID# 253016
🇺🇸Middleburg Heights, Ohio, United States
Clinical Research Source, Inc. /ID# 253027
🇺🇸Perrysburg, Ohio, United States
Oklahoma Medical Research Foundation /ID# 263509
🇺🇸Oklahoma City, Oklahoma, United States
Clinical Research of Philadelphia, LLC /ID# 254156
🇺🇸Philadelphia, Pennsylvania, United States
Albert Einstein Medical Center /ID# 256661
🇺🇸Philadelphia, Pennsylvania, United States
West Tennessee Research Institute /ID# 252807
🇺🇸Jackson, Tennessee, United States
Shelby Research /ID# 256937
🇺🇸Memphis, Tennessee, United States
Arthritis and Rheumatology Research Institute, PLLC /ID# 253014
🇺🇸Allen, Texas, United States
Arthritis Care of Texas /ID# 261719
🇺🇸Corpus Christi, Texas, United States
JPS Rheumatology Clinic /ID# 253185
🇺🇸Fort Worth, Texas, United States
Arthiritis and Rheumatology Specialists PA /ID# 255950
🇺🇸Fort Worth, Texas, United States
Integrative Rheumatology of South Texas /ID# 261977
🇺🇸Harlingen, Texas, United States
R & H Clinical Research - 777 Katy /ID# 254126
🇺🇸Katy, Texas, United States
Valley Arthritis Center /ID# 253022
🇺🇸McAllen, Texas, United States
Trinity Universal Research Associates, Inc /ID# 253013
🇺🇸Plano, Texas, United States
Sun Research Institute /ID# 255832
🇺🇸San Antonio, Texas, United States
Clinical Trials of Texas, Inc /ID# 254949
🇺🇸San Antonio, Texas, United States
DM Clinical Research - Tomball /ID# 255134
🇺🇸Tomball, Texas, United States
Carilion Clinic /ID# 253374
🇺🇸Roanoke, Virginia, United States
Emeritus Research Sydney /ID# 256249
🇦🇺Botany, New South Wales, Australia
Concord Repatriation General Hospital /ID# 257945
🇦🇺Concord, New South Wales, Australia
Momentum Clinical Research /ID# 253542
🇦🇺Darlinghurst, New South Wales, Australia
Royal Darwin Hospital /ID# 263160
🇦🇺Tiwi, Northern Territory, Australia
The Queen Elizabeth Hospital /ID# 253826
🇦🇺Woodville, South Australia, Australia
Emeritus Research /ID# 256800
🇦🇺Camberwell, Victoria, Australia
Monash Health - Monash Medical Centre /ID# 255678
🇦🇺Clayton, Victoria, Australia
Colin Bayliss Research and Teaching Unit /ID# 261077
🇦🇺Victoria Park, Western Australia, Australia
ZAS Palfijn /ID# 252802
🇧🇪Merksem, Antwerpen, Belgium
Universite Libre de Bruxelles - Hopital Erasme /ID# 261997
🇧🇪Anderlecht, Bruxelles-Capitale, Belgium
Institute of Physical Medicine,Rehab. and Orthopedic Surgery Dr.Miroslav Zotovic /ID# 262588
🇧🇦Banja Luka, Republika Srpska, Bosnia and Herzegovina
Klinicki centar Banja Luka /ID# 253581
🇧🇦Banja Luka, Republika Srpska, Bosnia and Herzegovina
Klinicki centar Banja Luka /ID# 253582
🇧🇦Banja Luka, Republika Srpska, Bosnia and Herzegovina
Clinical Center University of Sarajevo /ID# 253583
🇧🇦Sarajevo, Bosnia and Herzegovina
Polyclinic Srce Sarajeva /ID# 255475
🇧🇦Sarajevo, Bosnia and Herzegovina
SER - Servicos Especializados em Reumatologia da Bahia /ID# 253354
🇧🇷Salvador, Bahia, Brazil
CEDOES - Centro de Diagnóstico e Pesquisa da Osteoporose do Espírito Santo /ID# 254588
🇧🇷Vitoria, Espirito Santo, Brazil
CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 253346
🇧🇷Juiz de Fora, Minas Gerais, Brazil
EDUMED Educacao em Saude S/S LTDA /ID# 253274
🇧🇷Curitiba, Parana, Brazil
Hospital de Clinicas de Porto Alegre /ID# 253357
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
LMK Sevicos Medicos S/S /ID# 253353
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 261024
🇧🇷Sao Jose Do Rio Preto, Sao Paulo, Brazil
Hospital do Rim /ID# 253983
🇧🇷Sao Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 254316
🇧🇷Sao Paulo, Brazil
Medical Center Academy /ID# 253322
🇧🇬Sofiya, Sofia, Bulgaria
Umbal Kaspela /ID# 252645
🇧🇬Plovdiv, Bulgaria
Medical Center Artmed Ltd /Id# 254572
🇧🇬Plovdiv, Bulgaria
Medical center Unimed /ID# 253324
🇧🇬Plovdiv, Bulgaria
Medical center Teodora /ID# 252646
🇧🇬Ruse, Bulgaria
Military Medical Academy Multiprofile Hospital /ID# 252644
🇧🇬Sofia, Bulgaria
Diagnostic consultative center Focus-5 /ID# 252642
🇧🇬Sofiya, Bulgaria
Diagnostic consultative center Focus-5 /ID# 252643
🇧🇬Sofiya, Bulgaria
University of Calgary /ID# 259515
🇨🇦Calgary, Alberta, Canada
University of Manitoba /ID# 259517
🇨🇦Winnipeg, Manitoba, Canada
Servicio de Salud Araucanía Norte Hospital Victoria /ID# 255179
🇨🇱Victoria, Araucania, Chile
Hospital Guillermo Grant Benavente de Concepción /ID# 254841
🇨🇱Concepción, Bio-Bio, Chile
Inmunocel /Id# 256390
🇨🇱Las Condes, Region Metropolitana De Santiago, Chile
Centro Internacional de Estudios Clinicos - CIEC /ID# 254838
🇨🇱Santiago, Region Metropolitana Santiago, Chile
Investigaciones Medicas Limitada /Id# 254842
🇨🇱Providencia, Chile
The first affiliated hospital of bengbu medical college /ID# 252853
🇨🇳Bengbu, Anhui, China
China-Japan Friendship Hospital /ID# 253048
🇨🇳Beijing, Beijing, China
Peking University Third Hospital /ID# 253138
🇨🇳Beijing, Beijing, China
Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 253045
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Xiamen University /ID# 252630
🇨🇳Xiamen, Fujian, China
Guangdong Provincial People's Hospital /ID# 252920
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University /ID# 252921
🇨🇳Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 253137
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University /ID# 252927
🇨🇳Guangzhou, Guangdong, China
The Third Affiliated Hospital, Sun Yat-Sen University /ID# 252923
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Shantou University Medical College /ID# 253426
🇨🇳Shantou, Guangdong, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 252963
🇨🇳Wuhan, Hubei, China
Tongji Hospital Tongji Medical College of HUST /ID# 252632
🇨🇳Wuhan, Hubei, China
Zhuzhou Central Hospital /ID# 252962
🇨🇳Zhuzhou, Hunan, China
The Affiliated Hospital of Inner Mongolia Medical University /ID# 252629
🇨🇳Huhehaote, Inner Mongolia, China
The First People's Hospital of Changzhou /ID# 252992
🇨🇳Changzhou, Jiangsu, China
Nanjing Drum Tower Hospital /ID# 253042
🇨🇳Nanjing, Jiangsu, China
Affiliated hospital of nantong university /ID# 252991
🇨🇳Nantong, Jiangsu, China
Wuxi People's Hospital /ID# 253858
🇨🇳Wuxi, Jiangsu, China
Xuzhou Central Hospital /ID# 252922
🇨🇳Xuzhou, Jiangsu, China
Yancheng First People's Hospital /ID# 254599
🇨🇳Yancheng, Jiangsu, China
Northern Jiangsu People's Hospital /ID# 252945
🇨🇳Yangzhou, Jiangsu, China
The First People's Hospital of Jiujiang /ID# 252989
🇨🇳Jiujiang, Jiangxi, China
Jiangxi Provincial People's Hospital /ID# 252940
🇨🇳Nanchang, Jiangxi, China
Jiangxi Pingxiang People's Hospital /ID# 252919
🇨🇳Pingxiang, Jiangxi, China
The First Hospital of Jilin University /ID# 252771
🇨🇳Changchun, Jilin, China
Second Affiliated Hospital of Xian Jiaotong University /ID# 252861
🇨🇳Xi'an, Shaanxi, China
Jining No.1 People's Hospital /ID# 252897
🇨🇳Jining, Shandong, China
Linyi People's Hospital /ID# 252898
🇨🇳Linyi, Shandong, China
Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 263435
🇨🇳Shanghai, Shanghai, China
West China Hospital, Sichuan University /ID# 252854
🇨🇳Chengdu, Sichuan, China
Tianjin Medical University General Hospital /ID# 252868
🇨🇳Tianjin, Tianjin, China
People's Hospital of Xinjiang Uygur Autonomous Region /ID# 266897
🇨🇳Urumqi, Xinjiang, China
First Affiliated Hospital of Kunming Medical University /ID# 252925
🇨🇳Kunming, Yunnan, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 252633
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital /ID# 253860
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University /ID# 253649
🇨🇳Wenzhou, Zhejiang, China
Hospital Pablo Tobón Uribe /ID# 254101
🇨🇴Medellín, Antioquia, Colombia
Centro de Investigacion en Reumatologia y especialidades Medicas S.A.S- CIREEM /ID# 254097
🇨🇴Bogotá, Cundinamarca, Colombia
Healthy Medical Center S.A.S /ID# 254098
🇨🇴Zipaquirá, Cundinamarca, Colombia
Fundacion Oftalmologica de Santander - FOSCAL /ID# 254100
🇨🇴Bucaramanga, Santander, Colombia
Clinica de la Costa S.A.S /ID# 260727
🇨🇴Barranquilla, Colombia
Poliklinika Bonifarm /ID# 252846
🇭🇷Zagreb, Grad Zagreb, Croatia
Poliklinika Solmed /ID# 252965
🇭🇷Zagreb, Grad Zagreb, Croatia
Klinicki bolnicki centar Osijek /ID# 252847
🇭🇷Osijek, Osjecko-baranjska Zupanija, Croatia
Klinicki bolnicki centar Rijeka /ID# 252848
🇭🇷Rijeka, Primorsko-goranska Zupanija, Croatia
Klinicki Bolnicki Centar (KBC) Split /ID# 252849
🇭🇷Split, Splitsko-dalmatinska Zupanija, Croatia
Innomedica /ID# 253722
🇪🇪Tallinn, Harjumaa, Estonia
East Tallinn Central Hospital - Magdaleena Unit /ID# 253721
🇪🇪Tallinn, Harjumaa, Estonia
North Estonia Medical Centre Foundation /ID# 253723
🇪🇪Tallinn, Harjumaa, Estonia
MediTrials /ID# 253720
🇪🇪Tartu, Tartumaa, Estonia
CHU Toulouse - Hopital Rangueil /ID# 254148
🇫🇷Toulouse, Haute-Garonne, France
Hopital Pitie Salpetriere /ID# 253009
🇫🇷Paris, Ile-de-France, France
HCL - Hopital de la Croix-Rousse /ID# 254147
🇫🇷Lyon, Rhone, France
Krankenhaus Porz am Rhein /ID# 254373
🇩🇪Cologne, Nordrhein-Westfalen, Germany
Universitaetsmedizin Mainz /ID# 260735
🇩🇪Mainz, Rheinland-Pfalz, Germany
Immanuel Krankenhaus Berlin /ID# 253389
🇩🇪Berlin-buch, Germany
Fraunhofer Institute for Translational Medicine & Pharmacology ITMP /ID# 253734
🇩🇪Frankfurt am Main, Germany
General Hospital of Athens Laiko /ID# 252952
🇬🇷Athens, Attiki, Greece
University General Hospital Attikon /ID# 253209
🇬🇷Athens, Attiki, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 252951
🇬🇷Heraklion, Kriti, Greece
Clinica Medica Especializada en Medicina Interna y Reumatologia /ID# 261156
🇬🇹Guatemala, Guatemala
Clinica Medica Reumatologica /ID# 255009
🇬🇹Guatemala, Guatemala
Clinica Especializada en Medicina Interna /ID# 255006
🇬🇹Guatemala, Guatemala
Clínica Médica Especializada en Medicina Interna y Reumatologia /ID# 257248
🇬🇹Guatemala, Guatemala
Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 254552
🇭🇺Pecs, Baranya, Hungary
Debreceni Egyetem-Klinikai Kozpont /ID# 252877
🇭🇺Debrecen, Hajdu-Bihar, Hungary
Vital Medicina Kft /ID# 252876
🇭🇺Veszprém, Veszprem, Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 252886
🇭🇺Gyula, Hungary
The Lady Davis Carmel Medical Center /ID# 253303
🇮🇱Haifa, H_efa, Israel
Meir Medical Center /ID# 254187
🇮🇱Kfar Saba, HaMerkaz, Israel
Galilee Medical Center /ID# 252859
🇮🇱Nahariya, HaTsafon, Israel
The Chaim Sheba Medical Center /ID# 252857
🇮🇱Ramat Gan, Tel-Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 252858
🇮🇱Tel Aviv, Tel-Aviv, Israel
Hadassah Medical Center-Hebrew University /ID# 252654
🇮🇱Jerusalem, Yerushalayim, Israel
Azienda Ospedaliera San Camillo Forlanini /ID# 253680
🇮🇹Rome, Roma, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 254288
🇮🇹Rome, Roma, Italy
Azienda Ospedaliero Universitaria delle Marche /ID# 254138
🇮🇹Ancona, Italy
Azienda Ospedaliero Universitaria Pisana /ID# 254289
🇮🇹Pisa, Italy
National Hospital Organization Chibahigashi National Hospital /ID# 253268
🇯🇵Chiba-shi, Chiba, Japan
Hospital of the University of Occupational and Environmental Health, Japan /ID# 253269
🇯🇵Kitakyushu-shi, Fukuoka, Japan
Hokkaido University Hospital /ID# 253306
🇯🇵Sapporo-shi, Hokkaido, Japan
Tohoku University Hospital /ID# 253267
🇯🇵Sendai-shi, Miyagi, Japan
University of Miyazaki Hospital /ID# 253416
🇯🇵Miyazaki-shi, Miyazaki, Japan
Okayama University Hospital /ID# 253821
🇯🇵Okayama-shi, Okayama, Japan
Shinkenko Clinic /ID# 253271
🇯🇵Naha-shi, Okinawa, Japan
Saitama Medical Center /ID# 253263
🇯🇵Kawagoe-shi, Saitama, Japan
Institute of Science Tokyo Hospital /ID# 254430
🇯🇵Bunkyo-ku, Tokyo, Japan
University of Yamanashi Hospital /ID# 253264
🇯🇵Chuo-shi, Yamanashi, Japan
SoonChunHyang University Hospital Cheonan /ID# 254777
🇰🇷Cheonan-si, Chungcheongnamdo, Korea, Republic of
Chonnam National University Bitgoeul Hospital /ID# 254675
🇰🇷Gwangju, Gwangju Gwang Yeogsi, Korea, Republic of
Hanyang University Seoul Hospital /ID# 252955
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Asan Medical Center /ID# 254022
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 252958
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Riga East Clinical University Hospital /ID# 253751
🇱🇻Rīga, Riga, Latvia
M & M Centrs LTD /ID# 253752
🇱🇻Adazi, Latvia
Daugavpils Regional Hospital /ID# 253754
🇱🇻Daugavpils, Latvia
Pauls Stradins Clinical University Hospital /ID# 253750
🇱🇻Riga, Latvia
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 253755
🇱🇹Kaunas, Lithuania
Republic Klaipeda Hospital /ID# 253759
🇱🇹Klaipeda, Lithuania
Klaipeda University Hospital, Klaipeda Hospital /ID# 253757
🇱🇹Klaipeda, Lithuania
Inlita Santara CTC /ID# 253758
🇱🇹Vilnius, Lithuania
Vilnius University Hospital Santaros Klinikos /ID# 253756
🇱🇹Vilnius, Lithuania
Aotearoa Clinical Trials /ID# 253555
🇳🇿Papatoetoe, Auckland, New Zealand
North Shore Hospital /ID# 253554
🇳🇿Takapuna, Auckland, New Zealand
MICS Centrum Medyczne Bydgoszcz /ID# 253281
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 253233
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
MICS Centrum Medyczne Warszawa /ID# 253273
🇵🇱Warsaw, Mazowieckie, Poland
ETYKA-Osrodek Badan Klinicznych /ID# 252967
🇵🇱Olsztyn, Warminsko-mazurskie, Poland
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 252964
🇵🇱Poznan, Wielkopolskie, Poland
Centro Hospitalar do Tamega e Sousa - Hospital Padre Americo /ID# 252911
🇵🇹Guilhufe, Porto, Portugal
Hospital Garcia de Orta /ID# 252903
🇵🇹Almada, Setubal, Portugal
Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 252902
🇵🇹Ponte de Lima, Viana Do Castelo, Portugal
Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 252899
🇵🇹Porto, Portugal
Clinical Research Investigator Group, LLC /ID# 259170
🇵🇷Bayamon, Puerto Rico
Clinical Research Puerto Rico /ID# 256352
🇵🇷San Juan, Puerto Rico
GCM Medical Group PSC /ID# 253039
🇵🇷San Juan, Puerto Rico
Caribbean Medical Research Center /ID# 254882
🇵🇷San Juan, Puerto Rico
Mindful Medical Research /ID# 253040
🇵🇷San Juan, Puerto Rico
Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 252904
🇷🇴Cluj-Napoca, Cluj, Romania
Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL /ID# 253207
🇷🇴Brasov, Romania
Spitalul Clinic Sf. Maria /ID# 252905
🇷🇴Bucuresti, Romania
Institute for Rheumatology /ID# 253172
🇷🇸Belgrade, Beograd, Serbia
Institute for Rheumatology /ID# 253173
🇷🇸Belgrade, Beograd, Serbia
Institute for Rheumatology /ID# 253174
🇷🇸Belgrade, Beograd, Serbia
Institute for Rheumatology /ID# 253175
🇷🇸Belgrade, Beograd, Serbia
Military Medical Academy /ID# 264235
🇷🇸Belgrade, Beograd, Serbia
Clin Hosp Ctr Bezanijska Kosa /ID# 253179
🇷🇸Belgrade, Beograd, Serbia
General Hospital Djordje Joanovic /ID# 253177
🇷🇸Zrenjanin, Vojvodina, Serbia
University Clinical Center Vojvodina /ID# 253176
🇷🇸Novi Sad, Serbia
ARTROMAC n.o. /ID# 253056
🇸🇰Kosice, Kosicky Kraj, Slovakia
MEDMAN s.r.o. /ID# 252950
🇸🇰Martin, Zilinsky Kraj, Slovakia
ZAZABIE s. r .o. /ID# 255793
🇸🇰Košice II, Slovakia
Thermium s.r.o. /ID# 260839
🇸🇰Piestany, Slovakia
Wits Clinical Research /ID# 252931
🇿🇦Johannesburg, Gauteng, South Africa
University of Pretoria /ID# 252932
🇿🇦Pretoria, Gauteng, South Africa
Dr Elsa van Duuren /ID# 254218
🇿🇦Pretoria, Gauteng, South Africa
Dr Asokan Naidoo /ID# 253351
🇿🇦Umhlanga, Kwazulu-Natal, South Africa
Winelands Medical Research - Somerset West /ID# 254614
🇿🇦Cape Town, Western Cape, South Africa
Arthritis Clinical Research Trials /ID# 253349
🇿🇦Cape Town, Western Cape, South Africa
Winelands Medical Research Centre /ID# 252934
🇿🇦Stellenbosch, Western Cape, South Africa
Complejo Hospitalario Universitario A Coruña /ID# 253123
🇪🇸A Coruña, A Coruna, Spain
Hospital Meixoeiro (CHUVI) /ID# 253124
🇪🇸Vigo, Pontevedra, Spain
Hospital Universitario Virgen de Valme /ID# 253121
🇪🇸Sevilla, Spain
Universitätsspital Basel /ID# 252907
🇨🇭Basel Town, Basel-Stadt, Switzerland
Kantonsspital St. Gallen /ID# 252906
🇨🇭St. Gallen, Sankt Gallen, Switzerland
Inselspital, Universitaetsspital Bern /ID# 252909
🇨🇭Bern, Switzerland
National Taiwan University Hospital /ID# 252937
🇨🇳Taipei City, Taipei, Taiwan
Chang Gung Mem Hosp Keelung /ID# 253636
🇨🇳Keelung, Taiwan
China Medical University Hospital /ID# 252936
🇨🇳Taichung, Taiwan
Hacettepe Universitesi Tip Fak /ID# 253266
🇹🇷Sihhiye, Ankara, Turkey
Gazi Universitesi Tip Fakultes /ID# 252843
🇹🇷Yenimahalle, Ankara, Turkey
Sanko Universitesi Hastanesi /ID# 252841
🇹🇷Şehitkamil, Gaziantep, Turkey
Akdeniz Universitesi Tip Fakul /ID# 252839
🇹🇷Antalya, Turkey
Necmettin Erbakan Universitesi /ID# 252837
🇹🇷Meram Konya, Turkey
Karadeniz Technical University Farabi Hospital /ID# 252845
🇹🇷Trabzon, Turkey
North West Anglia NHS Foundation Trust /ID# 254590
🇬🇧Bretton, Cambridgeshire, United Kingdom
University Hospital Southampton NHS Foundation Trust /ID# 252982
🇬🇧Southampton, Hampshire, United Kingdom
Northampton General Hospital NHS Trust /ID# 254813
🇬🇧Northampton, Northamptonshire, United Kingdom
Western Health and Social Care Trust /ID# 254592
🇬🇧Londonderry, Northern Ireland, United Kingdom
Luton and Dunstable Hospital NHS Foundation Trust /ID# 255323
🇬🇧Luton, United Kingdom
Portsmouth Hospitals University NHS Trust /ID# 252986
🇬🇧Portsmouth, United Kingdom
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