[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05352919":3,"trial-entities:NCT05352919":1438,"trial-summary:NCT05352919":1442},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":46,"secondary_outcomes":54,"sex":115,"minimum_age":116,"maximum_age":117,"healthy_volunteers":118,"eligibility_criteria":119,"std_ages":128,"locations":131,"central_contacts":1431,"overall_officials":1432,"references":1436,"see_also_links":1437},"NCT05352919","230LE306","An Extension Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus","A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adult Participants With Active Systemic Lupus Erythematosus","ENROLLING_BY_INVITATION","2030-03-29","2026-07","2026-07-31","2022-06-10","Biogen","INDUSTRY",true,"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.\n\nThe main objective of the study is to learn more about the long-term safety of litifilimab. The main question researchers want to answer is:\n\n\\- 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.\n\nResearchers 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.\n\nThe study will be done as follows:\n\n* The Week 52 visit of studies 230LE303 and 230LE304 will be Day 1 of this study.\n* Participants who were receiving either a high or low dose of litifilimab in the parent studies will continue receiving the same doses.\n* Participants who were receiving placebo in the parent studies will be randomized to receive either a high or low dose of litifilimab.\n* All participants will receive litifilimab as injections under the skin once every 4 weeks. The treatment period will last 156 weeks. Participants may continue to take their standard of care medications.\n* Neither the researchers nor the participants will know which doses of litifilimab the participants are receiving.\n* There will be a follow-up safety period that lasts up to 24 weeks.\n* In total, participants will have up to 47 study visits. The total study duration for participants will be up to 180 weeks.\n\nOptional 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.\n\nThe primary objective of this study is to evaluate the long-term safety and tolerability of litifilimab in participants with active systemic lupus erythematosus (SLE).\n\nThe 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.\n\nA 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.\n\nThe primary objective of this substudy is to evaluate the safety of injector device used for administering litifilimab in participants with active SLE.\n\nThe secondary objective of this substudy is to evaluate the tolerability of injector device used for administering litifilimab in participants with active SLE.",[19],"Systemic Lupus Erythematosus (SLE)",[21,22,23,24],"Lupus Erythematosus","Systemic Autoimmune Diseases","Connective Tissue Diseases","Immune System Diseases","INTERVENTIONAL","TREATMENT",[28],"PHASE3",{"count":30,"type":31},864,"ESTIMATED",[33,42],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":40},"DRUG","Litifilimab","Administered as specified in the treatment arm.",[38,39],"Litifilimab High Dose","Litifilimab Low Dose",[41],"BIIB059",{"type":34,"name":43,"description":36,"armGroupLabels":44,"otherNames":45},"Litifilimab-matching placebo",[38,39],[41],[47,51],{"measure":48,"description":49,"timeFrame":50},"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",{"measure":52,"description":53,"timeFrame":50},"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\u002Fincapacity, results in a congenital anomaly\u002Fbirth defect, and is a medically important event.",[55,58,61,64,67,71,74,76,78,81,83,85,87,90,93,96,99,102,105,108,111,113],{"measure":56,"description":57,"timeFrame":50},"Percentage of Participants who Achieved an Systemic Lupus Erythematosus Responder Index (SRI)-4 Response","SRI-4 is a composite endpoint defined as the following:\n\n* A reduction from baseline of ≥4 points in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) score.\n* No new organ system affected, as defined by no new British Isles Lupus Activity Group-2004 (BILAG-2004 grade A) and no more than 1 new BILAG 2004 grade B versus previous visit.\n* No worsening from baseline in lupus disease activity as defined by \\\u003C0.3-point increase on 3-point Physician's Global Assessment (PGA) visual analog scale (VAS).\n* No violation of protocol-specified medication rules",{"measure":59,"description":60,"timeFrame":50},"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.",{"measure":62,"description":63,"timeFrame":50},"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.",{"measure":65,"description":66,"timeFrame":50},"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:\n\n* BILAG-2004 improvement, defined as all of BILAG-2004 Grade A at baseline improved to B, C, or D and all of BILAG-2004 Grade B at baseline improved to C or D.\n* 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.\n* No worsening in the SLEDAI-2K total score compared to baseline.\n* No worsening from baseline in lupus disease activity as defined by \\\u003C0.3-point increase on 3-point PGA VAS.\n* No violation of protocol-specified medication rules.",{"measure":68,"description":69,"timeFrame":70},"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:\n\n* Change in SLEDAI instrument score to \\>12\n* New or worse: central nervous system SLE; vasculitis; nephritis; myositis; platelets \\\u003C60,000\u002FmL, or hemolytic anemia with hemoglobin \\\u003C7 grams per deciliter (g\u002FdL) or decrease in hemoglobin \\>3 g\u002FdL and requiring: doubling prednisone dose, increase to \\>0.5 milligrams per kilograms per day (mg\u002Fkg\u002Fday) or hospitalization\n* Increase in prednisone dose to \\>0.5 mg\u002Fkg\u002Fday\n* New requirement for cyclophosphamide, azathioprine, methotrexate, or mycophenolate for SLE activity\n* Hospitalization for SLE activity\n* Increase in PGA score to \\>2.5","Up to Week 156",{"measure":72,"description":73,"timeFrame":50},"Percentage of Time Spent in Lupus Low Disease Activity State (LLDAS)","LLDAS is a composite endpoint defined as the following:\n\ni. 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\u002Fday; and v. Standard maintenance doses of immunosuppressive drugs and approved biological agents.\n\n\"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.",{"measure":75,"description":73,"timeFrame":50},"Percentage of Participants With Sustained LLDAS",{"measure":77,"description":73,"timeFrame":50},"Duration of Sustained LLDAS as Defined by the Number of Visits in LLDAS",{"measure":79,"description":80,"timeFrame":70},"Annual Change From Baseline Value From the Parent Phase 3 Studies in Systemic Lupus International Collaborating Clinics\u002FAmerican 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.",{"measure":82,"timeFrame":70},"Cumulative Exposure to OCS Over Time",{"measure":84,"timeFrame":70},"Percentage of Participants With OCS ≤7.5 mg",{"measure":86,"timeFrame":70},"Percentage of Participants With OCS ≤5 mg",{"measure":88,"description":89,"timeFrame":70},"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.",{"measure":91,"description":92,"timeFrame":70},"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).",{"measure":94,"description":95,"timeFrame":70},"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\u002Fdiscomfort, and anxiety\u002Fdepression. 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.",{"measure":97,"description":98,"timeFrame":70},"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\u002Ffamily 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.",{"measure":100,"description":101,"timeFrame":70},"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.",{"measure":103,"description":104,"timeFrame":70},"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 \u002F reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment \u002F absenteeism plus presenteeism) 4. Activity Impairment. Each score ranges from 0 to 100, with higher numbers indicating greater impairment and less productivity.",{"measure":106,"description":107,"timeFrame":70},"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.",{"measure":109,"description":110,"timeFrame":50},"Number of Participants with Clinically Relevant Abnormalities in Standard Laboratory Parameters","Standard laboratory parameters will include hematology, blood chemistry, urinalysis, and coagulation.",{"measure":112,"timeFrame":70},"Number of Participants with Clinically Relevant Abnormalities in Electrocardiogram (ECG) Results",{"measure":114,"timeFrame":50},"Number of Participants with Antibodies to Litifilimab","ALL","18 Years",null,false,{"inclusion":120,"exclusion":122,"raw_text":127},[121],"Participants who completed 1 of the 52-week of the double-blind placebo-controlled, parent Phase 3 studies (230LE303 (NCT04895241) and 230LE304 (NCT04961567)) on study treatments with either litifilimab or placebo to Week 48 and attended the last study assessment visit at Week 52.",[123,124,125,126],"Early parent Phase 3 studies treatment terminators (participants who discontinued study treatment before Week 52)","Early parent Phase 3 studies terminators (participants who withdrew from study participation and did not complete the 52-week treatment period)","Participants who developed moderate-to-severe worsening of organ-specific lupus manifestations that would require a change in antimalarials and\u002For immunosuppressive therapy (initiation of new treatment or increase in dose above the allowed maximum dose)","Use of other investigational drugs or off-label drugs used to treat SLE, cutaneous lupus, or lupus nephritis during the parent Phase 3 studies.","Key Inclusion Criteria:\n\n* Participants who completed 1 of the 52-week of the double-blind placebo-controlled, parent Phase 3 studies (230LE303 (NCT04895241) and 230LE304 (NCT04961567)) on study treatments with either litifilimab or placebo to Week 48 and attended the last study assessment visit at Week 52.\n\nKey Exclusion Criteria:\n\n* Early parent Phase 3 studies treatment terminators (participants who discontinued study treatment before Week 52)\n* Early parent Phase 3 studies terminators (participants who withdrew from study participation and did not complete the 52-week treatment period)\n* Participants who developed moderate-to-severe worsening of organ-specific lupus manifestations that would require a change in antimalarials and\u002For immunosuppressive therapy (initiation of new treatment or increase in dose above the allowed maximum dose)\n* Use of other investigational drugs or off-label drugs used to treat SLE, cutaneous lupus, or lupus nephritis during the parent Phase 3 studies.\n\nNOTE: Other inclusion\u002Fexclusion criteria may apply.",[129,130],"ADULT","OLDER_ADULT",[132,141,149,156,163,170,178,186,194,201,208,215,222,229,236,240,248,256,264,271,279,287,295,303,310,318,325,333,340,347,354,361,368,375,382,389,397,403,410,414,421,428,436,444,448,452,456,460,462,465,472,479,486,493,502,510,518,526,531,539,546,554,562,566,570,575,582,588,595,598,602,610,613,617,624,631,635,639,643,652,660,664,668,672,679,688,696,703,707,714,721,729,737,745,752,760,768,775,783,791,799,807,810,819,826,833,836,843,850,857,864,871,878,885,893,900,909,918,927,934,941,948,956,963,970,977,985,994,998,1005,1012,1016,1020,1027,1035,1040,1047,1051,1056,1064,1071,1076,1081,1085,1089,1098,1102,1109,1113,1117,1125,1133,1137,1144,1151,1159,1163,1167,1176,1183,1191,1198,1202,1209,1215,1219,1222,1226,1234,1241,1248,1255,1262,1269,1273,1280,1284,1292,1300,1307,1311,1318,1325,1333,1336,1340,1349,1356,1365,1372,1380,1387,1391,1399,1406,1415,1423],{"facility":133,"city":134,"state":135,"zip":136,"country":137,"geoPoint":138},"Arizona Arthritis & Rheumatology Associates, P.C.","Phoenix","Arizona","85037","United States",{"lat":139,"lon":140},33.44838,-112.07404,{"facility":142,"city":143,"state":144,"zip":145,"country":137,"geoPoint":146},"Wallace Rheumatic Study Center","Beverly Hills","California","90211",{"lat":147,"lon":148},34.07362,-118.40036,{"facility":150,"city":151,"state":144,"zip":152,"country":137,"geoPoint":153},"Care Access Research - 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Hospital","Toyoake-shi","470-1192",{"facility":999,"city":1000,"state":1000,"zip":1001,"country":990,"geoPoint":1002},"NHO Chibahigashi National Hospital","Chiba","260-8712",{"lat":1003,"lon":1004},35.6,140.11667,{"facility":1006,"city":1007,"state":1007,"zip":1008,"country":990,"geoPoint":1009},"KKR Hamanomachi Hospital","Fukuoka","810-8539",{"lat":1010,"lon":1011},33.6,130.41667,{"facility":1013,"city":1007,"state":1007,"zip":1014,"country":990,"geoPoint":1015},"NHO Kyushu Medical Center","810-8563",{"lat":1010,"lon":1011},{"facility":1017,"city":1018,"state":1007,"zip":1019,"country":990},"Hospital of the University of Occupational and Environmental Health","Kitakyushu-shi","807-8556",{"facility":1021,"city":1022,"state":1022,"zip":1023,"country":990,"geoPoint":1024},"Hiroshima University Hospital","Hiroshima","734-8551",{"lat":1025,"lon":1026},34.4,132.45,{"facility":1028,"city":1029,"state":1030,"zip":1031,"country":990,"geoPoint":1032},"Tonan Hospital","Sapporo","Hokkaido","060-0004",{"lat":1033,"lon":1034},43.06667,141.35,{"facility":1036,"city":1037,"state":1038,"zip":1039,"country":990},"Japanese Red Cross Society Himeji Hospital","Himeji-shi","Hyōgo","670-8540",{"facility":1041,"city":1042,"state":1038,"zip":1043,"country":990,"geoPoint":1044},"Kobe University Hospital","Kobe","650-0017",{"lat":1045,"lon":1046},34.6913,135.183,{"facility":1048,"city":1042,"state":1038,"zip":1049,"country":990,"geoPoint":1050},"Kobe City Hospital Organization Kobe City Medical Center General Hospital","650-0047",{"lat":1045,"lon":1046},{"facility":1052,"city":1053,"state":1054,"zip":1055,"country":990},"Kagawa University Hospital","Kita-gun","Kagawa-ken","761-0793",{"facility":1057,"city":1058,"state":1059,"zip":1060,"country":990,"geoPoint":1061},"NHO Yokohama Medical Center","Yokohama","Kanagawa","245-8575",{"lat":1062,"lon":1063},35.43333,139.65,{"facility":1065,"city":1066,"state":1066,"zip":1067,"country":990,"geoPoint":1068},"Japanese Red Cross Kumamoto Hospital","Kumamoto","861-8520",{"lat":1069,"lon":1070},32.80589,130.69181,{"facility":1072,"city":1073,"state":1074,"zip":1075,"country":990},"Kindai University Hospital","Osakasayama-shi","Osaka","589-8511",{"facility":1077,"city":1078,"state":1079,"zip":1080,"country":990},"Nihon University Itabashi Hospital","Itabashi-ku","Tokyo-To","173-8610",{"facility":1082,"city":1083,"state":1079,"zip":1084,"country":990},"Toho University Ohashi Medical Center","Meguro-ku","153-8515",{"facility":1086,"city":1087,"state":1079,"zip":1088,"country":990},"Center Hospital of the National Center for Global Health and Medicine","Shinjuku-ku","162-8655",{"facility":1090,"city":1091,"state":1092,"zip":1093,"country":1094,"geoPoint":1095},"Clinica de Investigacion en Reumatologia y Obesidad S.C.","Guadalajara","Jalisco","44650","Mexico",{"lat":1096,"lon":1097},20.67738,-103.34749,{"facility":1099,"city":1091,"state":1092,"zip":1100,"country":1094,"geoPoint":1101},"Centro de investigacion medica y reumatologia","44950",{"lat":1096,"lon":1097},{"facility":1103,"city":1104,"state":1104,"zip":1105,"country":1094,"geoPoint":1106},"Centro de Investigacion Clínica GRAMEL S.C","Mexico City","03720",{"lat":1107,"lon":1108},19.42847,-99.12766,{"facility":1110,"city":1104,"state":1104,"zip":1111,"country":1094,"geoPoint":1112},"Clinstile, S.A. de C.V.","06700",{"lat":1107,"lon":1108},{"facility":1114,"city":1104,"state":1104,"zip":1115,"country":1094,"geoPoint":1116},"Instituto Nacional de Ciencias Medicas y Nutricion Dr. Salvador Zubiran","14080",{"lat":1107,"lon":1108},{"facility":1118,"city":1119,"state":1120,"zip":1121,"country":1094,"geoPoint":1122},"Consultorio Privado Dr. Miguel Cortes Hernandez","Cuernavaca","Morelos","62448",{"lat":1123,"lon":1124},18.9261,-99.23075,{"facility":1126,"city":1127,"state":1128,"zip":1129,"country":1094,"geoPoint":1130},"Centro Peninsular de Investigacion Clinica, SCP","Mérida","Yucatán","97000",{"lat":1131,"lon":1132},20.967,-89.62318,{"facility":1134,"city":1127,"state":1128,"zip":1135,"country":1094,"geoPoint":1136},"Medical Care & Research SA de CV","97070",{"lat":1131,"lon":1132},{"facility":1138,"city":1139,"zip":1140,"country":1094,"geoPoint":1141},"Investigacion y Biomedicina de Chihuahua, S.C.","Chihuahua City","31000",{"lat":1142,"lon":1143},28.63528,-106.08889,{"facility":1145,"city":1146,"zip":1147,"country":1094,"geoPoint":1148},"Centro de Investigacion y Atencion Integral Durango CIAID","Durango","34080",{"lat":1149,"lon":1150},24.02032,-104.65756,{"facility":1152,"city":1153,"zip":1154,"country":1155,"geoPoint":1156},"Centro de Investigacion Clinica Inmunoreumatologia - ACQ Medic","Lima","LIMA 11","Peru",{"lat":1157,"lon":1158},-12.04318,-77.02824,{"facility":1160,"city":1153,"zip":1161,"country":1155,"geoPoint":1162},"HMA - Hospital Maria Auxiliadora","LIMA 29",{"lat":1157,"lon":1158},{"facility":1164,"city":1153,"zip":1165,"country":1155,"geoPoint":1166},"Invest Clinicas Sac Inst de Ginecologia y Reproduccion","LIMA 33",{"lat":1157,"lon":1158},{"facility":1168,"city":1169,"state":1170,"zip":1171,"country":1172,"geoPoint":1173},"Mary Mediatrix Medical Center","Lipa City","Batangas","4217","Philippines",{"lat":1174,"lon":1175},13.9411,121.1631,{"facility":1177,"city":1178,"state":1179,"zip":922,"country":1172,"geoPoint":1180},"Davao Doctors Hospital","Davao City","Davao Region",{"lat":1181,"lon":1182},7.07306,125.61278,{"facility":1184,"city":1185,"state":1186,"zip":1187,"country":1172,"geoPoint":1188},"University of the Philippines Manila - Philippine General Hospital","Manila","National Capital Region","1000",{"lat":1189,"lon":1190},14.6042,120.9822,{"facility":1192,"city":1193,"state":1186,"zip":1194,"country":1172,"geoPoint":1195},"St. Luke's Medical Center","Quezon City","1102",{"lat":1196,"lon":1197},14.6488,121.0509,{"facility":1199,"city":1193,"state":1186,"zip":1200,"country":1172,"geoPoint":1201},"Far Eastern University - Dr. Nicanor Reyes Medical Foundation","1118",{"lat":1196,"lon":1197},{"facility":1203,"city":1204,"zip":1205,"country":1172,"geoPoint":1206},"Ospital Ng Makati","City of Taguig","1642",{"lat":1207,"lon":1208},14.5243,121.0792,{"facility":1210,"city":1211,"zip":468,"country":1172,"geoPoint":1212},"The Medical City Iloilo","Iloilo City",{"lat":1213,"lon":1214},10.69694,122.56444,{"facility":1216,"city":1217,"zip":1218,"country":1172},"The Medical City Clark","Mabalacat, Pampanga","2023",{"facility":1220,"city":1185,"zip":1187,"country":1172,"geoPoint":1221},"Medical Center Manila",{"lat":1189,"lon":1190},{"facility":1223,"city":1185,"zip":1224,"country":1172,"geoPoint":1225},"Jose R. Reyes Memorial Medical Center","1012",{"lat":1189,"lon":1190},{"facility":1227,"city":1228,"zip":1229,"country":1230,"geoPoint":1231},"Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty","Bialystok","15-707","Poland",{"lat":1232,"lon":1233},53.13333,23.16433,{"facility":1235,"city":1236,"zip":1237,"country":1230,"geoPoint":1238},"Szpital Uniwersytecki nr 2 im.dr J. Biziela","Bydgoszcz","87-100",{"lat":1239,"lon":1240},53.1235,18.00762,{"facility":1242,"city":1243,"zip":1244,"country":1230,"geoPoint":1245},"Nzoz Bif-Med","Bytom","41-902",{"lat":1246,"lon":1247},50.34802,18.93282,{"facility":1249,"city":1250,"zip":1251,"country":1230,"geoPoint":1252},"Pratia MCM Krakow","Krakow","30-510",{"lat":1253,"lon":1254},50.06143,19.93658,{"facility":1256,"city":1257,"zip":1258,"country":1230,"geoPoint":1259},"Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.","Malbork","82-200",{"lat":1260,"lon":1261},54.03591,19.0266,{"facility":1263,"city":1264,"zip":1265,"country":1230,"geoPoint":1266},"Prywatna Praktyka Lekarska prof Pawel Hrycaj","Poznan","61-397",{"lat":1267,"lon":1268},52.40692,16.92993,{"facility":1270,"city":1264,"zip":1271,"country":1230,"geoPoint":1272},"Gabinety Lekarskie Rivermed","61-441",{"lat":1267,"lon":1268},{"facility":1274,"city":1275,"zip":1276,"country":1230,"geoPoint":1277},"Przychodnia Care Access Warszawa","Warsaw","00-719",{"lat":1278,"lon":1279},52.22977,21.01178,{"facility":1281,"city":1275,"zip":1282,"country":1230,"geoPoint":1283},"MICS Centrum Medyczne Warszawa","00-874",{"lat":1278,"lon":1279},{"facility":1285,"city":1286,"zip":1287,"country":1288,"geoPoint":1289},"Centro Reumatologico","Caguas","00725","Puerto Rico",{"lat":1290,"lon":1291},18.23412,-66.0485,{"facility":1293,"city":1294,"zip":1295,"country":1296,"geoPoint":1297},"S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L","Brasov","500283","Romania",{"lat":1298,"lon":1299},45.64861,25.60613,{"facility":1301,"city":1302,"zip":1303,"country":1296,"geoPoint":1304},"HIPERDIA SA- Centrul de Diagnostic si Tratament Hiperdia Oltenitei","Bucharest","041303",{"lat":1305,"lon":1306},44.43225,26.10626,{"facility":1308,"city":1302,"zip":1309,"country":1296,"geoPoint":1310},"S C Delta Health Care SRL","14142",{"lat":1305,"lon":1306},{"facility":1312,"city":1313,"zip":1314,"country":1296,"geoPoint":1315},"Spitalul Clinic Judetean de Urgenta Cluj Napoca","Cluj-Napoca","400006",{"lat":1316,"lon":1317},46.76667,23.6,{"facility":1319,"city":1320,"zip":1321,"country":1296,"geoPoint":1322},"S.C.Centrul Medical Unirea SRL","Iași","700023",{"lat":1323,"lon":1324},47.16667,27.6,{"facility":1326,"city":1327,"zip":1328,"country":1329,"geoPoint":1330},"Institute of Rheumatology","Belgrade","11000","Serbia",{"lat":1331,"lon":1332},44.80401,20.46513,{"facility":1334,"city":1327,"zip":1328,"country":1329,"geoPoint":1335},"University Clinical Center of Serbia",{"lat":1331,"lon":1332},{"facility":1337,"city":1327,"zip":1338,"country":1329,"geoPoint":1339},"Clinical Center \"Bezanijska Kosa \"","11080",{"lat":1331,"lon":1332},{"facility":1341,"city":1342,"state":1343,"zip":1344,"country":1345,"geoPoint":1346},"Ajou University Hospital","Suwon","Gyeonggi-do","16499","South Korea",{"lat":1347,"lon":1348},37.29111,127.00889,{"facility":1350,"city":1351,"zip":1352,"country":1345,"geoPoint":1353},"Hanyang University Seoul Hospital","Seoul","4763",{"lat":1354,"lon":1355},37.566,126.9784,{"facility":1357,"city":1358,"state":1359,"zip":1360,"country":1361,"geoPoint":1362},"Hospital General de Castellon","Castellon","Castellón","12004","Spain",{"lat":1363,"lon":1364},39.98567,-0.04935,{"facility":1366,"city":1367,"state":1359,"zip":1368,"country":1361,"geoPoint":1369},"Hospital Universitario Marques de Valdecilla","Santander","39008",{"lat":1370,"lon":1371},43.46589,-3.80493,{"facility":1373,"city":1374,"state":1375,"zip":1376,"country":1361,"geoPoint":1377},"Hospital Universitario Virgen Macarena","Seville","Sevilla","41009",{"lat":1378,"lon":1379},37.38283,-5.97317,{"facility":1381,"city":1382,"zip":1383,"country":1361,"geoPoint":1384},"Hospital Universitari Vall d'Hebron","Barcelona","08035",{"lat":1385,"lon":1386},41.38879,2.15899,{"facility":1388,"city":1374,"zip":1389,"country":1361,"geoPoint":1390},"Hospital Quironsalud Infanta Luisa","41010",{"lat":1378,"lon":1379},{"facility":1392,"city":1393,"zip":1394,"country":1395,"geoPoint":1396},"Kaohsiung Chang Gung Memorial Hospital","Kaohsiung City","833401","Taiwan",{"lat":1397,"lon":1398},22.61626,120.31333,{"facility":1400,"city":1401,"zip":1402,"country":1395,"geoPoint":1403},"Chung Shan Medical University Hospital","Taichung","40201",{"lat":1404,"lon":1405},24.1469,120.6839,{"facility":1407,"city":1408,"state":1409,"zip":1410,"country":1411,"geoPoint":1412},"Guy's Hospital","London","Greater London","SE1 9RT","United Kingdom",{"lat":1413,"lon":1414},51.50853,-0.12574,{"facility":1416,"city":1417,"state":1418,"zip":1419,"country":1411,"geoPoint":1420},"Doncaster Royal Infirmary","Doncaster","South Yorkshire","DN2 5LT",{"lat":1421,"lon":1422},53.52285,-1.13116,{"facility":1424,"city":1425,"state":1426,"zip":1427,"country":1411,"geoPoint":1428},"Cannock Chase Hospital","Cannock","Staffordshire","WS11 5XY",{"lat":1429,"lon":1430},52.69045,-2.03085,[],[1433],{"name":1434,"affiliation":13,"role":1435},"Medical Director","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":1439,"biomarkers":1441},[1440],"Systemic Lupus Erythematosus",[],{"nct_id":4,"found":118,"summary":117,"prompt_version":117}]