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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-006378-22 | EudraCT Number | ||
| 2023-505635-13 | Other Identifier | EU CTIS Number |
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In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. This is an extension study of 230LE303 and 230LE304 (TOPAZ-1 and TOPAZ-2). It will enroll participants who completed the treatment periods of either one of the parent studies.
The main objective of the study is to learn more about the long-term safety of litifilimab. The main question researchers want to answer is:
- How many participants have adverse events and serious adverse events? Researchers will also learn about the effect litifilimab has on controlling symptoms of SLE and lowering its activity. They will measure symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the British Isles Lupus Activity Group-2004 (BILAG-2004), among others.
Researchers will also study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires.
The study will be done as follows:
Optional Substudy: Some participants may be invited to join an optional substudy after being in the main study for at least 4 months. This substudy will test a new injector device for giving litifilimab. The injector device is an automatic device that delivers the full dose in one injection without needing to push a plunger. Researchers will compare the safety and tolerability of the injector device and how the body reacts to it to the current prefilled syringe method. The substudy will last 3 months and will include about 120 participants.
This is an extension study for all participants who completed study 230LE303 (NCT04895241) and 230LE304 (NCT04961567) (parent phase 3 studies) through Week 52 and did not discontinue litifilimab or placebo. Eligible participants from parent phase 3 studies will be followed for up to 180 weeks.
The primary objective of this study is to evaluate the long-term safety and tolerability of litifilimab in participants with active systemic lupus erythematosus (SLE).
The secondary objectives of this study are to evaluate the long-term effect of litifilimab on disease activity in participants with SLE, to evaluate the long-term effect of litifilimab in participants with SLE in maintaining low disease activity, to evaluate the effect of litifilimab in participants with active SLE in preventing irreversible organ damage, to assess long-term use of oral corticosteroid (OCS) with participants receiving litifilimab treatment, to assess the impact of litifilimab on participant-reported Health-Related Quality-of-Life Questionnaire (HRQoL), symptoms, and impacts of SLE, to evaluate long-term effect of litifilimab on laboratory parameters, and to evaluate immunogenicity of litifilimab.
A phase-3, randomized, dose-blind, substudy is added in this extension study for all participants who have been enrolled in the 230LE306 Phase 3 LTE study for a minimum of 4 months and have at least four remaining visits in the Phase 3 LTE study.
The primary objective of this substudy is to evaluate the safety of injector device used for administering litifilimab in participants with active SLE.
The secondary objective of this substudy is to evaluate the tolerability of injector device used for administering litifilimab in participants with active SLE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Litifilimab Low Dose | Experimental | Participants who are receiving background nonbiologic lupus standard of care (SOC) therapy and received litifilimab low dose, subcutaneously (SC), every 4 weeks (Q4W) during the parent Phase 3 studies (i.e. studies 230LE303 [NCT04895241] or 230LE304 [NCT04961567]) will continue to receive litifilimab low dose, SC, Q4W from Day 1 up to 152 weeks with an additional dose of litifilimab-matching placebo at Week 2. Participants who are receiving background nonbiologic lupus SOC therapy and received litifilimab-matching placebo in the parent Phase 3 studies (i.e. studies 230LE303 [NCT04895241] or 230LE304 [NCT04961567]) will be randomized to receive litifilimab low dose, SC, Q4W from Day 1 up to 152 weeks with an additional dose at Week 2. |
|
| Litifilimab High Dose | Experimental | Participants who are receiving background nonbiologic lupus SOC therapy and received litifilimab high dose, SC, Q4W during the parent Phase 3 studies (i.e. studies 230LE303 [NCT04895241] or 230LE304 [NCT04961567]) will continue to receive litifilimab high dose, SC, Q4W from Day 1 up to 152 weeks with an additional dose of litifilimab-matching placebo at Week 2. Participants who are receiving background nonbiologic lupus SOC therapy and received litifilimab-matching placebo in the parent Phase 3 studies (i.e. studies 230LE303 [NCT04895241] or 230LE304 [NCT04961567]) will be randomized to receive litifilimab high dose, SC, Q4W from Day 1 up to 152 weeks with an additional dose at Week 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Litifilimab | Drug | Administered as specified in the treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that started or worsened in severity after the first dose of study treatment through 28 days after the last dose of study treatment or end of study (EOS) date, whichever comes earlier. | Up to Week 180 |
| Number of Participants with Serious Adverse Events (SAEs) | An SAE is any untoward medical occurrence that at any dose results in death, in the view of the Investigator, places the participant at immediate risk of death (a life threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, and is a medically important event. | Up to Week 180 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants who Achieved an Systemic Lupus Erythematosus Responder Index (SRI)-4 Response | SRI-4 is a composite endpoint defined as the following:
|
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Arthritis & Rheumatology Associates, P.C. | Phoenix | Arizona | 85037 | United States | ||
| Wallace Rheumatic Study Center |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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| Litifilimab-matching placebo | Drug | Administered as specified in the treatment arm. |
|
|
| Up to Week 180 |
| Percentage of Participants With at Least 4 Joints (Both Swollen and Tender) at Baseline who Achieved a Joint-50 Response | Joint-50 response is a 50% reduction in total active joint count from baseline. An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion). A 28-joint assessment will be performed to determine the active joint count, which is defined as the sum of tender and swollen joint counts. | Up to Week 180 |
| Percentage of Participants With a Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) Score ≥10 at Baseline who Achieved a CLASI-50, CLASI-70, and CLASI-90 Response | CLASI score is used to evaluate lupus skin manifestations. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Scores for each area are assigned based on the most severe lesion within the area of interest. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-50, CLASI-70, and CLASI-90 responders are defined as ≥ 50%, ≥ 70%, and ≥ 90% improvement in CLASI-A score from baseline at the specified timepoint. | Up to Week 180 |
| Percentage of Participants who Achieved a British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) Response | BICLA is a composite endpoint defined as the following:
| Up to Week 180 |
| Annualized Severe Safety of Estrogens in Systemic Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index Flare Index (SFI) Flare Rate | A severe flare is defined as any of the following:
| Up to Week 156 |
| Percentage of Time Spent in Lupus Low Disease Activity State (LLDAS) | LLDAS is a composite endpoint defined as the following: i. SLEDAI-2K score ≤ 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and ii. No new features of lupus disease activity compared with the previous assessment; and iii. SELENA-SLEDAI PGA ≤ 1; and iv. Current prednisone (or equivalent) dose ≤ 7.5 mg/day; and v. Standard maintenance doses of immunosuppressive drugs and approved biological agents. "No new features" is defined as any new SLEDAI-2K component that was not present at the previous assessment. The SELENA-SLEDAI PGA Scale ranges from 0-3, where 0 is no disease activity and 3 is maximum disease activity. "Standard maintenance doses" include drugs limited to those allowed per protocol. | Up to Week 180 |
| Percentage of Participants With Sustained LLDAS | LLDAS is a composite endpoint defined as the following: i. SLEDAI-2K score ≤ 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and ii. No new features of lupus disease activity compared with the previous assessment; and iii. SELENA-SLEDAI PGA ≤ 1; and iv. Current prednisone (or equivalent) dose ≤ 7.5 mg/day; and v. Standard maintenance doses of immunosuppressive drugs and approved biological agents. "No new features" is defined as any new SLEDAI-2K component that was not present at the previous assessment. The SELENA-SLEDAI PGA Scale ranges from 0-3, where 0 is no disease activity and 3 is maximum disease activity. "Standard maintenance doses" include drugs limited to those allowed per protocol. | Up to Week 180 |
| Duration of Sustained LLDAS as Defined by the Number of Visits in LLDAS | LLDAS is a composite endpoint defined as the following: i. SLEDAI-2K score ≤ 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and ii. No new features of lupus disease activity compared with the previous assessment; and iii. SELENA-SLEDAI PGA ≤ 1; and iv. Current prednisone (or equivalent) dose ≤ 7.5 mg/day; and v. Standard maintenance doses of immunosuppressive drugs and approved biological agents. "No new features" is defined as any new SLEDAI-2K component that was not present at the previous assessment. The SELENA-SLEDAI PGA Scale ranges from 0-3, where 0 is no disease activity and 3 is maximum disease activity. "Standard maintenance doses" include drugs limited to those allowed per protocol. | Up to Week 180 |
| Annual Change From Baseline Value From the Parent Phase 3 Studies in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) Score | SDI score is used to assess the accumulated damage in participants with SLE. It assess 12 organ systems and records damage in participants with lupus, regardless of its cause. Damage could be due to previous disease activity, medication, or intercurrent illness (such as surgery or cancer). To distinguish between active inflammation and damage, an item must be present for at least 6 months. It is assumed that persistent inflammation (for at least 6 months) would result in tissue injury and hence damage. SDI is evaluated on a scale 0-47 with higher score indicating higher damage. | Up to Week 156 |
| Cumulative Exposure to OCS Over Time | Up to Week 156 |
| Percentage of Participants With OCS ≤7.5 mg | Up to Week 156 |
| Percentage of Participants With OCS ≤5 mg | Up to Week 156 |
| Change From Baseline in Lupus-Specific Health-Related Quality-Of-Life (LupusQoL) Score | The LupusQoL is a participant-reported, lupus-specific, HRQoL questionnaire consisting of 34 items grouped in 8 domains: physical health, pain, planning, intimate relationships, burden to others, emotional health, body image and fatigue. Participants indicate their responses on a 5-point Likert response format, where 4 = never, 3 = occasionally, 2 = a good bit of the time, 1 = most of the time, and 0 = all the time. A LupusQoL score for each domain will be reported on a 0 to 100 scale, with greater values indicating better HRQoL. | Up to Week 156 |
| Change From Baseline in Short Form Health Survey-36 (SF-36) (Acute Version) Score | The SF-36 is a 36-item scale which assesses HRQoL in 8 domains: limitations in physical activities due to health problems, limitations in social activities due to physical or emotional problems, limitations in usual role activities due to physical health problems, bodily pain, general mental health (psychological distress and well-being), limitations in usual role activities due to emotional problems, vitality (energy and fatigue), general health perceptions. The SF-36 (Acute Version) form asks for participants to reply to questions (items) according to how they have felt over a specifically defined period of time. Items 1-4 primarily contribute to the physical component summary (PCS) score of the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the SF-36 where higher scores indicate best health. Scores on each item are summed and averaged (range: 0=worse health to 100=best possible health). | Up to Week 156 |
| Change From Baseline in European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L) | The EQ-5D is a standardized generic measure of health status developed by the European Quality of Life Group. This study uses the EQ-5D-3L version of the instrument. This instrument consists of 2 sections. The first section comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. All dimensions are measured on a 3-point scale, 1: No problems; 2: Some problems; 3: Extreme problems. The second section comprises the Visual Analogue Scale, which records the respondent's self-rated health on a vertical scale ranging from 0 to 100, lower scores indicate the worst possible health state. | Up to Week 156 |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score | The FACIT-Fatigue is a participant-administered HRQoL questionnaire that evaluates participant's fatigue in 5 broad categories: physical well-being, social/family well-being, emotional well-being, functional well-being and additional concerns. The level of fatigue is measured by questions assessed on a 5-point scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The responses for each item are added to obtain a total score which ranges from 0 to 52, with a higher score indicating less fatigue. | Up to Week 156 |
| Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Score | The PHQ-9 is a participant-administered HRQoL questionnaire to screen for the presence and severity of depression. The PHQ-9 is a participant-reported outcome (PRO) that is used to measure depression in adults. It contains 9 questions, with a 2 week recall period. The PHQ-9 yields an overall severity score that can range from 0 to 27 with the following severity scores: 0-4 = none; 5-9 = mild; 10-14 = moderate; 15-19 = moderate-to-severe; and 20-27 = severe. | Up to Week 156 |
| Change From Baseline in Work Productivity and Activity Impairment (WPAI):Lupus Score | WPAI questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. Each score ranges from 0 to 100, with higher numbers indicating greater impairment and less productivity. | Up to Week 156 |
| Change from Baseline in Patient Global Assessment (PtGA) Score | The PtGA is participant-administered, single-item question evaluating the impact of health and illness, with responses ranging from very poor to very well on a 100 mm VAS. The participant will consider the previous week when addressing this question. | Up to Week 156 |
| Number of Participants with Clinically Relevant Abnormalities in Standard Laboratory Parameters | Standard laboratory parameters will include hematology, blood chemistry, urinalysis, and coagulation. | Up to Week 180 |
| Number of Participants with Clinically Relevant Abnormalities in Electrocardiogram (ECG) Results | Up to Week 156 |
| Number of Participants with Antibodies to Litifilimab | Up to Week 180 |
| Beverly Hills |
| California |
| 90211 |
| United States |
| Care Access Research - Huntington Beach | Huntington Beach | California | 92648 | United States |
| Providence Facey Medical Foundation | Mission Hills | California | 91345 | United States |
| Inland Rheumatology Clinical Trials, Inc. | Upland | California | 91786 | United States |
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| Georgetown University Hospital-Medstar | Washington D.C. | District of Columbia | 20007-2113 | United States |
| Arthritis & Rheumatic Disease Specialties | Aventura | Florida | 33180 | United States |
| Highlands Research Institute | Avon Park | Florida | 33825 | United States |
| Clinical Research of West Florida - Corporate | Clearwater | Florida | 33765 | United States |
| GNP Research at Mark Jaffe, MD | Cooper City | Florida | 33024 | United States |
| Omega Research Consultants | DeBary | Florida | 32713 | United States |
| Life Clinical Trials | Margate | Florida | 33063 | United States |
| Clinical Research of West Florida, Inc. | Tampa | Florida | 33606 | United States |
| AdventHealth Medical Group | Tampa | Florida | 33613 | United States |
| Arthritis Center of North Georgia | Gainesville | Georgia | 30501 | United States |
| University of Massachusetts Chan Medical School | Worcester | Massachusetts | 01655 | United States |
| AA MRC LLC Ahmed Arif Medical Research Center | Flint | Michigan | 48504 | United States |
| Precision Comprehensive Clinical Research Solutions | Rochester Hills | Michigan | 48307 | United States |
| Saint Louis Rheumatology | St Louis | Missouri | 63119 | United States |
| NYU Langone Brooklyn | Brooklyn | New York | 11220 | United States |
| DJL Clinical Research, PLLC | Charlotte | North Carolina | 28210 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States |
| Paramount Medical Research & Consulting, LLC | Middleburg Heights | Ohio | 44130 | United States |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | United States |
| Ramesh C Gupta, MD | Memphis | Tennessee | 38119 | United States |
| Arthritis & Rheumatology Research Institute | Allen | Texas | 75013 | United States |
| Tekton Research - PARENT | Austin | Texas | 78745 | United States |
| Accurate Clinical Research | Baytown | Texas | 77521 | United States |
| Precision Comprehensive Clinical Research Solution | Colleyville | Texas | 76034-5913 | United States |
| Prolato Clinical Research Center | Houston | Texas | 77054 | United States |
| Accurate Clinical Research, Inc. | Humble | Texas | 77338 | United States |
| R and H Clinical Research | Katy | Texas | 77450 | United States |
| Sun Research Institute, LLC | San Antonio | Texas | 78215 | United States |
| Advanced Rheumatology of Houston | The Woodlands | Texas | 77382 | United States |
| Swedish Medical Center | Seattle | Washington | 98104 | United States |
| Organizacion Medica de Investigacion (OMI) | CABA | Buenos Aires | C1015ABO | Argentina |
| Centro de Investigaciones Medicas Mar del Plata | Mar del Plata | Buenos Aires | 7600 | Argentina |
| Policlìnica Red Omip S.A - Ensayos Clinicos GC | Mar del Plata | Buenos Aires | B7600GNY | Argentina |
| Centro Dermatologico Schejtman | San Miguel | Buenos Aires | B1663 | Argentina |
| Centro Medico Barrio Parque | Buenos Aires | Ciudad Autonoma Buenos Aires | 1425 | Argentina |
| Instituto CAICI | Rosario | Santa Fe Province | S2000PBJ | Argentina |
| Clinica Mayo de Urgencias Medicas Cruz Blanca SRL | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Centro de Investigaciones Medicas Tucuman | San Miguel de Tucumán | Tucumán Province | T4000AXL | Argentina |
| Investigaciones Clinicas Tucuman | San Miguel de Tucumán | Tucumán Province | T4000ICL | Argentina |
| Hospital Italiano de La Plata | Buenos Aires | 17251900 | Argentina |
| Instituto de Investigaciones Clinicas Quilmes | Buenos Aires | 3151878 | Argentina |
| Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada | Ciudad Autonoma Buenos Aires | 1425 | Argentina |
| STAT Research S.A. | Ciudad Autonoma Buenos Aires | C1013AAB | Argentina |
| Sanatorio Allende | Córdoba | 5000 | Argentina |
| Instituto de Reumatologia | Mendoza | 5500 | Argentina |
| CER San Juan Centro Polivalente de Asistencia e Inv. Clinica | San Juan | 5400 | Argentina |
| Centre Hospitalier Universitaire de Liege | Liège | 4000 | Belgium |
| HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará | Fortaleza | Ceará | 60430-372 | Brazil |
| CEDOES - Diagnóstico e Pesquisa | Vitória | Espírito Santo | 29055-450 | Brazil |
| Clínica SER da Bahia | Salvador | Estado de Bahia | 40150-150 | Brazil |
| L2IP - Instituto de Pesquisas Clínicas Ltda. | Brasília | Federal District | 70200-730 | Brazil |
| IPC MT Instituto de Pesquisas Clinicas do Mato Grosso | Santo Ângelo | Mato Grosso | 78020-500 | Brazil |
| Santa Casa de Misericordia de Belo Horizonte | Belo Horizonte | Minas Gerais | 30150-221 | Brazil |
| CMiP - Centro Mineiro de Pesquisa | Juiz de Fora | Minas Gerais | 36010-570 | Brazil |
| CETI - Centro de Estudos em Terapias Inovadoras Ltda. | Curitiba | Paraná | 80030-110 | Brazil |
| Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| LMK Serviços Médicos S/S Ltda | Porto Alegre | Rio Grande do Sul | 90480-000 | Brazil |
| Hospital Moinhos de Vento | Porto Alegre | Rio Grande do Sul | 90560032 | Brazil |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto | Sao Jose Rio Preto | São Paulo | 15090-000 | Brazil |
| Centro Multidisciplinar de Estudos Clínicos - CEMEC | São Bernardo do Campo | São Paulo | 09715-090 | Brazil |
| CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos | São Paulo | São Paulo | 01228-200 | Brazil |
| A2Z Clinical Centro Avancado de Pesquisa Clinica | Valinhos | São Paulo | 13271-130 | Brazil |
| RDSS Ricardo Diaz Scientific Solution | São Paulo | 04037-030 | Brazil |
| MC Artmed OOD | Plovdiv | 4002 | Bulgaria |
| UMHAT "Pulmed" OOD | Plovdiv | 4002 | Bulgaria |
| UMHAT-Plovdiv AD | Plovdiv | 4003 | Bulgaria |
| DCC 1 - Ruse, EOOD | Rousse | 7002 | Bulgaria |
| DCC 'Alexandrovska', EOOD | Sofia | 1431 | Bulgaria |
| DCC Focus 5 - MEOH OOD | Sofia | 1463 | Bulgaria |
| Military Medical Academy - MHAT - Sofia | Sofia | 1606 | Bulgaria |
| UMHAT 'Sv. Ivan Rilski', EAD | Sofia | 1612 | Bulgaria |
| Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |
| Centro Medico Prosalud | Santiago | 7500000 | Chile |
| CTR Estudios | Santiago | 7500571 | Chile |
| Enroll Spa | Santiago | 7500587 | Chile |
| BioMedica Research Group | Santiago | 7500710 | Chile |
| Clinical Research Chile SpA. | Valdivia | 5090000 | Chile |
| Xuanwu Hospital Capital Medical University | Beijing | Beijing Municipality | 100053 | China |
| Dongguan People's Hospital | Dongguan | Guangdong | 523059 | China |
| Guangdong Second Provincial General Hospital | Guangzhou | Guangdong | 510317 | China |
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | 510515 | China |
| Shenzhen People's Hospital | Shenzhen | Guangdong | 518020 | China |
| Zhongshan TCM Hospital | Zhongshan | Guangdong | 528400 | China |
| Hainan General Hospital | Haikou | Hainan | 570311 | China |
| The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | 50000 | China |
| Xiangya Hospital, Central South University | Changsha | Hu'nan | 410008 | China |
| ZhuZhou Central Hospital | Zhuzhou | Hu'nan | 412000 | China |
| The Second Affiliated Hospital of Soochow University | Suzhou | Jiangsushe | 215004 | China |
| Jiujiang No.1 People's Hospital | Jiujiang | Jiangxi | 332000 | China |
| Pingxiang People's Hospital | Pingxiang | Jiangxi | 337055 | China |
| Jilin Province People's Hospital | Changchun | Jilin | 130021 | China |
| Binzhou Medical University Hospital | Binzhou | Shandong | 256603 | China |
| Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch | Shanghai | Shanghai Municipality | 200001 | China |
| The First Affiliated Hospital of Ningbo University | Ningbo | Zhejiang | 315010 | China |
| The First Hospital of Jilin University | Changchun | 130021 | China |
| IPS Centro Medico Julian Coronel S.A. | Cali | Valle del Cauca Department | 760001 | Colombia |
| Fundacion Cardiomet CEQUIN S.A.S | Armenia | 630004 | Colombia |
| Centro de Investigacion Medico Asistencial S.A.S | Barranquilla | 080020 | Colombia |
| Clínica de la Costa S.A.S | Barranquilla | 080020 | Colombia |
| Centro de Investigacion en Reumatologia y Especialidades Medicas CIREEM S.A.S. | Bogotá | 110221 | Colombia |
| Servimed S.A.S. | Bucaramanga | 680003 | Colombia |
| Preventive Care Ltda | Chía | 250001 | Colombia |
| Fundacion Oftalmologica de Santander - FOSCAL | Floridablanca | 681004 | Colombia |
| Healthy Medical Center | Zipaquirá | 250252 | Colombia |
| Revmatologie s.r.o. | Brno | 63800 | Czechia |
| Fakultni nemocnice Olomouc | Olomouc | 77520 | Czechia |
| CHU Clermont Ferrand - Hopital Gabriel Montpied | Clermont-Ferrand | Drôme | 63003 | France |
| NNA Hospital | Athens | Attica | 11521 | Greece |
| Vita Verum Medical Egeszsegugyi Szolgaltato Bt. | Székesfehérvár | Fejér | 8000 | Hungary |
| Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet | Budapest | 1097 | Hungary |
| Bekes Varmegyei Kozponti Korhaz | Gyula | 5700 | Hungary |
| Vital Medical Center | Veszprém | 8200 | Hungary |
| Rambam Health Care Campus | Haifa | 3109601 | Israel |
| Meir Medical Center | Kfar Saba | 44281 | Israel |
| Chaim Sheba Medical Center | Ramat Gan | 5265601 | Israel |
| Tel Aviv Sourasky Medical Center Pt | Tel Aviv | 6423906 | Israel |
| Azienda Ospedaliera San Camillo Forlanini | Roma | 152 | Italy |
| JCHO Chukyo Hospital | Nagoya | Aichi-ken | 457-8510 | Japan |
| Fujita Health University Hospital | Toyoake-shi | Aichi-ken | 470-1192 | Japan |
| NHO Chibahigashi National Hospital | Chiba | Chiba | 260-8712 | Japan |
| KKR Hamanomachi Hospital | Fukuoka | Fukuoka | 810-8539 | Japan |
| NHO Kyushu Medical Center | Fukuoka | Fukuoka | 810-8563 | Japan |
| Hospital of the University of Occupational and Environmental Health | Kitakyushu-shi | Fukuoka | 807-8556 | Japan |
| Hiroshima University Hospital | Hiroshima | Hiroshima | 734-8551 | Japan |
| Tonan Hospital | Sapporo | Hokkaido | 060-0004 | Japan |
| Japanese Red Cross Society Himeji Hospital | Himeji-shi | Hyōgo | 670-8540 | Japan |
| Kobe University Hospital | Kobe | Hyōgo | 650-0017 | Japan |
| Kobe City Hospital Organization Kobe City Medical Center General Hospital | Kobe | Hyōgo | 650-0047 | Japan |
| Kagawa University Hospital | Kita-gun | Kagawa-ken | 761-0793 | Japan |
| NHO Yokohama Medical Center | Yokohama | Kanagawa | 245-8575 | Japan |
| Japanese Red Cross Kumamoto Hospital | Kumamoto | Kumamoto | 861-8520 | Japan |
| Kindai University Hospital | Osakasayama-shi | Osaka | 589-8511 | Japan |
| Nihon University Itabashi Hospital | Itabashi-ku | Tokyo-To | 173-8610 | Japan |
| Toho University Ohashi Medical Center | Meguro-ku | Tokyo-To | 153-8515 | Japan |
| Center Hospital of the National Center for Global Health and Medicine | Shinjuku-ku | Tokyo-To | 162-8655 | Japan |
| Clinica de Investigacion en Reumatologia y Obesidad S.C. | Guadalajara | Jalisco | 44650 | Mexico |
| Centro de investigacion medica y reumatologia | Guadalajara | Jalisco | 44950 | Mexico |
| Centro de Investigacion Clínica GRAMEL S.C | Mexico City | Mexico City | 03720 | Mexico |
| Clinstile, S.A. de C.V. | Mexico City | Mexico City | 06700 | Mexico |
| Instituto Nacional de Ciencias Medicas y Nutricion Dr. Salvador Zubiran | Mexico City | Mexico City | 14080 | Mexico |
| Consultorio Privado Dr. Miguel Cortes Hernandez | Cuernavaca | Morelos | 62448 | Mexico |
| Centro Peninsular de Investigacion Clinica, SCP | Mérida | Yucatán | 97000 | Mexico |
| Medical Care & Research SA de CV | Mérida | Yucatán | 97070 | Mexico |
| Investigacion y Biomedicina de Chihuahua, S.C. | Chihuahua City | 31000 | Mexico |
| Centro de Investigacion y Atencion Integral Durango CIAID | Durango | 34080 | Mexico |
| Centro de Investigacion Clinica Inmunoreumatologia - ACQ Medic | Lima | LIMA 11 | Peru |
| HMA - Hospital Maria Auxiliadora | Lima | LIMA 29 | Peru |
| Invest Clinicas Sac Inst de Ginecologia y Reproduccion | Lima | LIMA 33 | Peru |
| Mary Mediatrix Medical Center | Lipa City | Batangas | 4217 | Philippines |
| Davao Doctors Hospital | Davao City | Davao Region | 8000 | Philippines |
| University of the Philippines Manila - Philippine General Hospital | Manila | National Capital Region | 1000 | Philippines |
| St. Luke's Medical Center | Quezon City | National Capital Region | 1102 | Philippines |
| Far Eastern University - Dr. Nicanor Reyes Medical Foundation | Quezon City | National Capital Region | 1118 | Philippines |
| Ospital Ng Makati | City of Taguig | 1642 | Philippines |
| The Medical City Iloilo | Iloilo City | 5000 | Philippines |
| Medical Center Manila | Manila | 1000 | Philippines |
| Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty | Bialystok | 15-707 | Poland |
| Szpital Uniwersytecki nr 2 im.dr J. Biziela | Bydgoszcz | 87-100 | Poland |
| Nzoz Bif-Med | Bytom | 41-902 | Poland |
| Pratia MCM Krakow | Krakow | 30-510 | Poland |
| Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o. | Malbork | 82-200 | Poland |
| Prywatna Praktyka Lekarska prof Pawel Hrycaj | Poznan | 61-397 | Poland |
| Gabinety Lekarskie Rivermed | Poznan | 61-441 | Poland |
| Przychodnia Care Access Warszawa | Warsaw | 00-719 | Poland |
| MICS Centrum Medyczne Warszawa | Warsaw | 00-874 | Poland |
| Centro Reumatologico | Caguas | 00725 | Puerto Rico |
| S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L | Brasov | 500283 | Romania |
| HIPERDIA SA- Centrul de Diagnostic si Tratament Hiperdia Oltenitei | Bucharest | 041303 | Romania |
| S C Delta Health Care SRL | Bucharest | 14142 | Romania |
| Spitalul Clinic Judetean de Urgenta Cluj Napoca | Cluj-Napoca | 400006 | Romania |
| S.C.Centrul Medical Unirea SRL | Iași | 700023 | Romania |
| Institute of Rheumatology | Belgrade | 11000 | Serbia |
| University Clinical Center of Serbia | Belgrade | 11000 | Serbia |
| Clinical Center "Bezanijska Kosa " | Belgrade | 11080 | Serbia |
| Ajou University Hospital | Suwon | Gyeonggi-do | 16499 | South Korea |
| Hanyang University Seoul Hospital | Seoul | 4763 | South Korea |
| Hospital Universitario Marques de Valdecilla | Santander | Castellón | 39008 | Spain |
| Hospital Universitario Virgen Macarena | Seville | Sevilla | 41009 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Quironsalud Infanta Luisa | Seville | 41010 | Spain |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | 833401 | Taiwan |
| Chung Shan Medical University Hospital | Taichung | 40201 | Taiwan |
| Guy's Hospital | London | Greater London | SE1 9RT | United Kingdom |
| Doncaster Royal Infirmary | Doncaster | South Yorkshire | DN2 5LT | United Kingdom |
| Cannock Chase Hospital | Cannock | Staffordshire | WS11 5XY | United Kingdom |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D007154 | Immune System Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
Not provided
Not provided