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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505696-74 | Other Identifier | EU CTIS |
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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.
The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is:
- How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the 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), the British Isles Lupus Activity Group-2004 index (BILAG-2004), and the BILAG-BASED Combined Lupus Assessment (BICLA), among others.
Researchers will also learn more about the safety of litifilimab. They will 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:
The primary objective of the study is to demonstrate efficacy of litifilimab compared with placebo in participants with active SLE, who are receiving background lupus standard of care (SOC) therapy in reducing disease activity.
The secondary objectives of this study are to demonstrate efficacy of litifilimab compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing disease activity and occurrence of flare up to Week 52; to demonstrate organ-specific efficacy of litifilimab compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing joint disease activity and skin disease activity; to demonstrate and evaluate effect of litifilimab compared with placebo in reducing oral corticosteroid(s) (OCS) use; to evaluate additional efficacy of litifilimab compared with placebo in reducing disease activity with additional disease activity measures; assess the difference between litifilimab and placebo on participant reported health-related quality of life (HRQoL), symptoms, and impacts of SLE; to evaluate the safety, tolerability and immunogeneicty of litifilimab in participants with active SLE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Litifilimab High Dose | Experimental | Participants who are receiving background nonbiologic lupus SOC therapy will receive high dose of litifilimab, subcutaneously (SC), every 4 weeks (Q4W), up to Week 48 with an additional dose at Week 2. |
|
| Litifilimab Low Dose | Experimental | Participants who are receiving background nonbiologic lupus SOC therapy will receive low dose of litifilimab, SC Q4W, up to Week 48 with an additional dose at Week 2. |
|
| Placebo | Placebo Comparator | Participants who are receiving background nonbiologic lupus SOC therapy will receive litifilimab-matching placebo, SC Q4W, up to Week 48 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 |
|---|---|---|
| Percentage of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index of 4 (SRI-4) Response at Week 52 | An SRI-4 response is a composite endpoint defined by the following criteria:
| Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved a British Isles Lupus Activity Group (BILAG) - Based Combined Lupus Assessment (BICLA) Response at Week 52 | The BILAG disease activity index evaluates SLE activity in number of organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows, BILAG A: severe disease activity; BILAG B: moderate disease activity; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved. BICLA is a composite endpoint defined as BILAG-2004 improvement, defined as all BILAG-2004 grade A at Baseline improved to grade B, C, or D, and all BILAG-2004 grade B at baseline improved to grade C or D, no BILAG-2004 worsening in other BILAG-2004 organ systems such that there are no new BILAG-2004 grade A or greater than 1 new BILAG-2004 grade B, no worsening in the SLEDAI-2K total score compared with Baseline, no worsening from Baseline in lupus disease activity defined by < 0.3-point increase on 3-point PGA-VAS and no violation to protocol-specified medication rules. |
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Key Inclusion Criteria:
Participant must be diagnosed with SLE at least 24 weeks prior to screening and must meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE, at screening by a qualified physician.
Participant has a modified Systemic Lupus Erythematosus Disease Activity Index-200 (SLEDAI-2K) score ≥6 (excluding alopecia, fever, lupus-related headache, and organic brain syndrome) at screening (adjudicated).
Participant has a modified clinical SLEDAI-2K score ≥4 (excluding anti-dsDNA, low complement component 3 [C3] and/or complement component 4 [C4], alopecia, fever, lupus-related headache, and organic brain syndrome) at screening (adjudicated) and randomization.
Participant has BILAG-2004 grade A in ≥1 organ system or BILAG-2004 grade B in ≥2 organ systems at screening (adjudicated) and randomization.
Participants must be treated with one of the following background nonbiologic lupus SOC therapies, initiated ≥12 weeks prior to screening and at stable dose ≥4 weeks prior to randomization:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Arizona Arthritis & Rheumatology Associates, P.C. |
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| Label | URL |
|---|---|
| Click here to learn more about this trial, visit our study website. | View source |
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In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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| Placebo | Drug | Administered as specified in the treatment arm. |
|
| Week 52 |
| Percentage of Participants With at Least 4 Joints (Both Swollen and Tender) at Baseline Who Achieved a Joint-50 Response at Week 52 | Joint-50 response is 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. | Week 52 |
| Percentage of Participants With Oral Corticosteroid(s) (OCS) ≥10 milligrams per day (mg/day) at Baseline With OCS Reduction to ≤7.5 mg/day at Week 40, Which Is Sustained Through Week 52 With No Disease Worsening from Week 40 to Week 52 | No worsening of the disease is defined as no new BILAG-2004 grade A or less than 2 new BILAG-2004 grade B since the last visit during the Week 40 to Week 52. | Week 40 up to Week 52 |
| Percentage of Participants With a CLASI-A Score ≥10 at Baseline Who Achieved a 50% Improvement from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI-50) Response at Week 24 | Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) score is used to evaluate lupus skin manifestations. 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 is 50% of improvement form baseline in CLASI-A. | Week 24 |
| Annualized Flare Rate Through Week 52 | Annualized flare rate will be calculated as the total number of flares divided by the flare exposure time in days, and the ratio multiplied by 365.25. | Up to Week 52 |
| Change from Baseline in Physician's Global Assessment (PGA) - Visual Analog Scale (VAS) Score by Visit | The PGA is an investigator-administered assessment used to quantify disease activity and is measured using an anchored VAS. PGA asks the investigator to assess the participant's current disease activity from a score of 0 (none) to 3 (severe), with the assessment made relative to the most severe state of SLE. | Up to Week 52 |
| Percentage of Participants Who Achieved a BICLA Response by Visit | The BILAG disease activity index evaluates SLE activity in number of organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows, BILAG A: severe disease activity; BILAG B: moderate disease activity; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved. BICLA is a composite endpoint defined as BILAG-2004 improvement, defined as all BILAG-2004 grade A at Baseline improved to grade B, C, or D, and all BILAG-2004 grade B at baseline improved to grade C or D, no BILAG-2004 worsening in other BILAG-2004 organ systems such that there are no new BILAG-2004 grade A or greater than 1 new BILAG-2004 grade B, no worsening in the SLEDAI-2K total score compared with Baseline, no worsening from Baseline in lupus disease activity defined by < 0.3-point increase on 3-point PGA-VAS and no violation to protocol-specified medication rules. | Up to Week 52 |
| Time to Onset of SRI-4 Response Sustained Through Week 52 | An SRI-4 response is a composite endpoint defined by the following criteria:
| Up to Week 52 |
| Percentage of Participants Who Achieved SRI-4, -5, or -6 Response by Visit | An SRI-4 response is a composite endpoint defined by the following criteria:
| Up to Week 52 |
| Percentage of Participants With Joint-50 Response by Visit | Joint-50 response is 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 52 |
| Percentage of Participants With Baseline CLASI-A Score ≥10 Who Achieved a CLASI-20, -50, -70, or -90 Response by Visit | Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) score is used to evaluate lupus skin manifestations. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-20, -50, -70 and -90 represent 20%, 50%, 70% or 90% improvement from baseline in CLASI-A score, respectively. | Up to Week 52 |
| Percentage of Participants With Baseline CLASI-A Score ≥10 Who Achieved a CLASI-A Score of ≤1 by Visit | Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) score is used to evaluate lupus skin manifestations. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-A ≤1 represent the absolute score ≤1 in CLASI-A by visit. | Up to Week 52 |
| Percentage of Participants With Severe Flares Through Week 52 | A SFI severe flare is defined any of the following:
| Up to Week 52 |
| Time to First British Isles Lupus Activity Group-2004 (BILAG-2004) Severe Flare by Visit | BILAG-2004 severe flare is defined as an A score for items recorded as worse or new. BILAG-2004 is evaluated by scoring each item of a list of signs and symptoms given as 4 = new; 3 = worse; 2 = same; 1 = improving; 0 = not present; and ND = not done. | Up to Week 52 |
| Time to First Severe Flare as Defined by Safety of Estrogens in Systemic Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index Flare Index (SFI) | SFI severe flare is defined any of the following: change in SLEDAI instrument score to >12; or new or worse: central nervous system SLE; vasculitis; nephritis; myositis; platelets <60,000 per milliliter (/mL); or hemolytic anemia with hemoglobin <7 grams per deciliter (g/dL) or decrease in hemoglobin >3 g/dL and requiring: doubling prednisone dose; or increase to >0.5 milligrams per kilogram per day (mg/kg/day) or hospitalization; or increase in prednisone dose to >0.5 mg/kg/day; or new requirement for cyclophosphamide, azathioprine, methotrexate, or mycophenolate for SLE activity; or hospitalization for SLE activity; or increase in PGA score to >2.5. | Up to Week 52 |
| Percentage of Time Spent in Lupus Low Disease Activity State (LLDAS) | LLDAS is a composite endpoint defined as:
| Up to Week 52 |
| Percentage of Participants With Sustained LLDAS as Defined by the Number of Participants With ≥ 3, ≥ 5, and ≥ 7 Consecutive Visits in LLDAS up to and Including Week 52 | LLDAS is a composite endpoint defined as:
| Up to Week 52 |
| Percentage of Participants who Achieved LLDAS at Week 52 | LLDAS is a composite endpoint defined as:
| Week 52 |
| Percentage of Participants who Achieved SLEDAI-2K Improvement at Week 52 | The SLEDAI-2K is a reliable, valid, simple, 1-page activity index that measures disease activity and records features of active lupus as present or not. It uses a weighted checklist to assign a numeric score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 28 days. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms), where higher scores represent increased disease activity. SLEDAI-2K improvement is defined as a reduction from Baseline of ≥ 4 points in SLEDAI-2K score. | Week 52 |
| Percentage of Participants who Achieved no Worsening of BILAG at Week 52 | The BILAG disease activity index evaluates SLE activity in number of organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows, BILAG A: severe disease activity; BILAG B: moderate disease activity; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved. No worsening of BILAG is defined as no new organ system affected, as defined by no new organ system with BILAG-2004 grade A and no more than 1 new organ system with BILAG-2004 grade B compared with Baseline. | Week 52 |
| Percentage of Participants who Achieved no Worsening of PGA-VAS at Week 52 | The PGA is an investigator-administered assessment used to quantify disease activity and is measured using an anchored VAS. PGA asks the investigator to assess the participant's current disease activity from a score of 0 (none) to 3 (severe), with the assessment made relative to the most severe state of SLE. No worsening from Baseline in lupus disease activity is defined by < 0.3-point increase on 3-point PGA-VAS. | Week 52 |
| Percentage of Participants who Achieved no Worsening of SLEDAI-2K at Week 52 | The SLEDAI-2K is a reliable, valid, simple, 1-page activity index that measures disease activity and records features of active lupus as present or not. It uses a weighted checklist to assign a numeric score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 28 days. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms), where higher scores represent increased disease activity. No worsening of SLEDAI-2K is defined as no increase in the SLEDAI-2K total score from baseline. | Week 52 |
| Percentage of Participants who Achieved BILAG Improvement at Week 52 | The BILAG disease activity index evaluates SLE activity in number of organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows, BILAG A: severe disease activity; BILAG B: moderate disease activity; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved. BILAG-2004 improvement, defined as all BILAG-2004 grade A at Baseline improved to grade B, C, or D, and all BILAG-2004 grade B at Baseline improved to grade C or D. BILAG-2004 improvement, defined as all BILAG-2004 grade A at Baseline improved to grade B, C, or D, and all BILAG-2004 grade B at Baseline improved to grade C or D. BILAG-2004 improvement, defined as all BILAG-2004 grade A at Baseline improved to grade B, C, or D, and all BILAG-2004 grade B at Baseline improved to grade C or D. | Week 52 |
| Percentage of Participants With OCS ≥ 10 mg/day at Baseline With OCS Reduction to ≤ 5 mg/day at Week 40, Which is Sustained Through Week 52 With no Disease Worsening From Week 40 to Week 52 | No worsening of the disease is defined as no new BILAG-2004 grade A or less than 2 new BILAG-2004 grade B since the last visit between Week 40 and Week 52 | Week 40 up to Week 52 |
| Percentage of Participants With Baseline OCS ≥10 mg/day Who Achieved ≤7.5 mg/day at Week 52 | Week 52 |
| Percentage of Participants With OCS ≥ 7.5 mg/day at Baseline With OCS Reduction to ≤ 7.5 mg/day at Week 52 | Week 52 |
| Change from Baseline in Lupus-Specific Health-Related Quality-of-Life Questionnaire (LupusQoL) Score | The LupusQoL is a participant-reported, lupus-specific, health-related quality-of-life questionnaire (HRQoL) 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 52 |
| Change from Baseline in Short Form Health Survey-36 (SF-36) Score | SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary (PCS) score of SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. | Up to Week 52 |
| Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score | FACIT-Fatigue is a participant-administered HRQoL questionnaire that evaluates participant's fatigue in the 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 52 |
| Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score | 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. 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 52 |
| 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. Presenteeism (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 scores indicating greater impairment and less productivity. | Up to Week 52 |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. 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. An SAE is any untoward medical occurrence that at any dose results in death (a life-threatening event), in the view of the investigator, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a birth defect, or is a medically important event. | Up to Week 52 |
| Number of Participants With Antibodies to Litifilimab | Up to Week 52 |
| Glendale |
| Arizona |
| 85306 |
| United States |
| Care Access Research - Huntington BeachCare Access Research - Huntington Beach | Huntington Beach | California | 92648 | United States |
| Valerius Medical Group | Los Alamitos | California | 90720 | United States |
| The Practice of Medicine | Los Angeles | California | 90004 | United States |
| R. Srinivasan, M.D., Inc. dba Monterey Park Medical Center | Monterey Park | California | 91754 | United States |
| Neurovations | Napa | California | 94558 | United States |
| Joo-Hyung Lee MD | Orange | California | 92868 | United States |
| Medvin Clinical Research | Whittier | California | 90602 | United States |
| RASF - Clinical Research Center | Boca Raton | Florida | 33486 | United States |
| University of Florida | Gainesville | Florida | 32611 | United States |
| Vida Clinical Research | Kissimmee | Florida | 34741 | United States |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
| HMD Research, LLC | Orlando | Florida | 32819 | United States |
| Clinical Research of West Florida, Inc. | Tampa | Florida | 33606 | United States |
| The Emory Clinic Emory University | Atlanta | Georgia | 30322 | United States |
| Jefrey Lieberman, M.D., P.C. | Decatur | Georgia | 30033 | United States |
| Southeastern Rheumatology Alliance dba Arthritis Center of North Georgia | Gainesville | Georgia | 30501 | United States |
| RNA America Health Sciences | Gainesville | Georgia | 30518 | United States |
| EBGS Clinical Trials | Snellville | Georgia | 30078 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Boston University School of Medicine | Boston | Massachusetts | 02118 | United States |
| DM Clinical Research - Boston | Brookline | Massachusetts | 02445 | United States |
| University of Massachusetts | Worcester | Massachusetts | 01655 | United States |
| Saint Louis Rheumatology | St Louis | Missouri | 63119 | United States |
| Arthritis & Osteoporosis Associates, PA | Freehold | New Jersey | 07728 | United States |
| Arthritis and Osteoporosis Associates of New Mexico | Las Cruces | New Mexico | 88011 | United States |
| DJL Clinical Research, PLLC | Charlotte | North Carolina | 28210 | United States |
| Carolina Arthritis Associates | Wilmington | North Carolina | 28401 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45206-0829 | United States |
| STAT Research | Dayton | Ohio | 45417 | United States |
| Piedmont Arthritis Clinic, P.A. | Greenville | South Carolina | 29601 | United States |
| Low Country Rheumatology, PA | Summerville | South Carolina | 29486 | United States |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | United States |
| Arthritis & Rheumatology Institute | Allen | Texas | 75013 | United States |
| Office of John P. Lavery M.D., PA | Allen | Texas | 75013 | United States |
| Tekton Research | Austin | Texas | 78745 | United States |
| Precision Comprehensive Clinical Research Solutions | Colleyville | Texas | 76034 | United States |
| R and H Clinical Research | Katy | Texas | 77494 | United States |
| Prime Clinical Research | Mansfield | Texas | 76063 | United States |
| SouthWest Rheumatology Research, LLC | Mesquite | Texas | 75150 | United States |
| Sun Research Institute, LLC | San Antonio | Texas | 78215 | United States |
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Swedish Medical Center | Seattle | Washington | 98104 | United States |
| Instituto de Investigaciones Clinicas Quilmes | Buenos Aires | Buenos Aires | B1878GEG | Argentina |
| Hospital Italiano de La Plata | Buenos Aires | Buenos Aires | B1900AXI | Argentina |
| Hospital General de Agudos Dr. J. M. Ramos Mejia | Ciudad Autonoma Buenos Aires | Buenos Aires | C1221ADC | Argentina |
| Centro de Investigaciones Medicas Mar del Plata | Mar del Plata | Buenos Aires | B7600FYK | 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 |
| APRILLUS Asistencia e Investigacion | Buenos Aires | Ciudad Autonoma Buenos Aires | C1406AGA | 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 |
| Centro Medico Barrio Parque | Buenos Aires | C1425 | 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 |
| Organizacion Medica de Investigacion (OMI) | Ciudad Autonoma Buenos Aires | C1015ABO | Argentina |
| Hospital Britanico de Buenos Aires | Ciudad Autonoma Buenos Aires | C1280AEB | Argentina |
| Centro Privado de Medicina Familiar - Mind Out Research | Ciudad Autonoma Buenos Aires | C1417 | Argentina |
| Sanatorio Allende | Córdoba | X5000JHQ | Argentina |
| Instituto de Reumatologia | Mendoza | M5500 | Argentina |
| CER San Juan Centro Polivalente de Asistencia e Inv. Clinica | San Juan | 5400 | Argentina |
| UZ Leuven | Leuven | 3000 | Belgium |
| Centre Hospitalier Universitaire de Liege | Liège | 4000 | Belgium |
| The Waterside Clinic | Barrie | Ontario | L4M 6L2 | Canada |
| Hamilton Health Sciences Corporation | Hamilton | Ontario | L8V 1C3 | Canada |
| The Ottawa Hospital - General Campus | Ottawa | Ontario | K1H 8L6 | Canada |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | 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 |
| Hainan General Hospital | Haikou | Hainan | 570311 | China |
| The second Xiangya Hospital of Central South University | Changsha | Hu'nan | 410011 | China |
| ZhuZhou Central Hospital | Zhuzhou | Hu'nan | 412000 | China |
| EC of Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
| Jiangxi Pingxiang People's Hospital | Pingxiang | Jiangxi | 337055 | China |
| Jilin Province People's Hospital | Changchun | Jilin | 130021 | China |
| Yanbian University Hospital (Yanbian Hospital) | Yanji | Jilin | 133000 | China |
| Jiujiang No.1 People's Hospital | Jiujiang | Jiujiang | 332000 | China |
| Binzhou Medical University Hospital | Binzhou | Shandong | 256603 | China |
| Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch | Shanghai | Shanghai Municipality | 200001 | China |
| Ruijin Hospital of Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200011 | China |
| The First Affiliated Hospital of Chengdu Medical College | Chengdu | Sichuan | 610500 | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
| The First Affiliated Hospital of Ningbo University | Ningbo | Zhejiang | 315010 | China |
| Wenzhou People's Hospital | Wenzhou | Zhejiang | 325000 | China |
| Beijing Chaoyang Hospital, Capital Medical University | Beijing | 100020 | China |
| Xuanwu Hospital Capital Medical University | Beijing | 100053 | China |
| The First Hospital of Jilin University | Changchun | 130021 | China |
| Xiangya Hospital, Central South University | Changsha | 410008 | China |
| Centro de Investigacion Medico Asistencial S.A.S | Barranquilla | 080020 | Colombia |
| Clínica de la Costa Ltda. | 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 |
| IPS Centro Medico Julián Coronel S.A. | Cali | 760001 | Colombia |
| Preventive Care Ltda | Chía | 250001 | Colombia |
| Healthy Medical Center | Zipaquirá | 250252 | Colombia |
| Revmatologie s.r.o. | Brno | 638 00 | Czechia |
| Fakultni nemocnice Olomouc | Olomouc | 77520 | Czechia |
| Universitaetsmedizin Goettingen | Göttingen | Lower Saxony | 37075 | Germany |
| Medizinische Hochschule Hannover | Hanover | Lower Saxony | 30625 | Germany |
| Universitaetsklinikum Koeln | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Universitaetsklinikum Muenster | Münster | North Rhine-Westphalia | 48149 | Germany |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Mainz | Rhineland-Palatinate | 55131 | Germany |
| Obudai Egeszsegugyi Centrum Kft. | Budapest | 1036 | Hungary |
| Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet | Budapest | 1097 | Hungary |
| Bekes Varmegyei Kozponti Korhaz | Gyula | 5700 | Hungary |
| Vita Verum Medical Egeszsegugyi Szolgaltato Bt. | Székesfehérvár | 8000 | Hungary |
| Vital Medical Center | Veszprém | 8200 | Hungary |
| Rambam Health Care Center | Haifa | 3109601 | Israel |
| Meir Medical Center | Kfar Saba | 44281 | Israel |
| Rabin Medical Center-Beilinson Campus | Petah Tikva | 49372 | Israel |
| Chaim Sheba Medical Center | Ramat Gan | 5265601 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 6423906 | Israel |
| Istituto Clinico Humanitas | Rozzano | Milano | 20089 | Italy |
| Ospedale M. Scarlato | Scafati | Salerno | 84018 | Italy |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) | Brescia | 25123 | Italy |
| Azienda Ospedale-Università di Padova | Padova | 35100 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | 56100 | Italy |
| Azienda Ospedaliera San Camillo Forlanini | Roma | 00151 | Italy |
| Università Campus Bio-Medico di Roma | Roma | 00155 | Italy |
| Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza | Roma | 00161 | Italy |
| JCHO Chukyo Hospital | Nagoya | Aichi-ken | 457-8510 | Japan |
| Fujita Health University Hospital | Toyoake-shi | Aichi-ken | 470-1192 | Japan |
| Chiba University Hospital | Chiba | Chiba | 260-8677 | Japan |
| NHO Chibahigashi National Hospital | Chiba | Chiba | 260-8712 | Japan |
| Chibaken Saiseikai Narashino Hospital | Narashino-shi | Chiba | 275-8580 | 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, Japan | 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 |
| St. Marianna University Hospital | Kawasaki-shi | Kanagawa | 216-8511 | Japan |
| Kitasato University Hospital | Sagamihara-shi | Kanagawa | 252-0375 | Japan |
| Yokohama City University Medical Center | Yokohama | Kanagawa | 232-0024 | Japan |
| NHO Yokohama Medical Center | Yokohama | Kanagawa | 245-8575 | Japan |
| Japanese Red Cross Kumamoto Hospital | Kumamoto | Kumamoto | 861-8520 | Japan |
| Tohoku University Hospital | Sendai | Miyagi | 980-8574 | Japan |
| Nagasaki University Hospital | Nagasaki | Nagasaki | 852-8501 | Japan |
| NHO Osaka Minami Medical Center | Kawachinagano-shi | Osaka | 586-8521 | Japan |
| Tazuke-kofukai Medical Research Institute Kitano Hospital | Osaka | Osaka | 530-8480 | Japan |
| Kindai University Hospital | Osakasayama-shi | Osaka | 589-8511 | Japan |
| Osaka Medical and Pharmaceutical University Hospital | Takatsuki-shi | Osaka | 569-8686 | Japan |
| Saitama Medical University Hospital | Iruma-gun | Saitama | 350-0495 | Japan |
| Tokyo Medical and Dental University Hospital | Bunkyō City | Tokyo-To | 113-8519 | Japan |
| St. Luke's International Hospital | Chūōku | Tokyo-To | 104-8560 | Japan |
| Nihon University Itabashi Hospital | Itabashi-ku | Tokyo-To | 173-8610 | Japan |
| Toho University Ohashi Medical Center | Meguro-ku | Tokyo-To | 153-8515 | Japan |
| Toho University Omori Medical Center | Ōta-ku | Tokyo-To | 143-8541 | Japan |
| Keio University Hospital | Shinjuku-ku | Tokyo-To | 160-8582 | Japan |
| Center Hospital of the National Center for Global Health and Medicine | Shinjuku-ku | Tokyo-To | 162-8655 | Japan |
| Amsterdam UMC, Locatie VUMC | Amsterdam | 1081 HV | Netherlands |
| Universitair Medisch Centrum Groningen | Groningen | 9700 RB | Netherlands |
| UMC Utrecht | Utrecht | 3584 CX | Netherlands |
| Centro Reumatologico | Caguas | 00725 | Puerto Rico |
| S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L | Brasov | 500283 | Romania |
| S C Delta Health Care SRL | Bucharest | 014142 | Romania |
| Spitalul Clinic Judetean de Urgenta Cluj Napoca | Cluj-Napoca | 400006 | Romania |
| S.C.Centrul Medical Unirea SRL | Iași | 700023 | Romania |
| Spitalul Judetean de Urgenta 'Sf. Ioan cel Nou' Suceava | Suceava | 720284 | Romania |
| S.C Centrul Medical Unirea SRL | Târgu Mureş | 540136 | Romania |
| Institute of Rheumatology | Belgrade | 11000 | Serbia |
| University Clinical Center of Serbia | Belgrade | 11000 | Serbia |
| Clinical Hospital Center Bezanijska kosa | Belgrade | 11080 | Serbia |
| Institute of Treatment and Rehabilitation 'Niska Banja' | Niška Banja | 18205 | Serbia |
| Whipps Cross University Hospital | London | Greater London | E11 1NR | United Kingdom |
| 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 |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided