[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597294":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":18,"locations":28,"responsibleParty":48,"collaborators":10,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":10,"eligibilityCriteria":56,"healthyVolunteers":53,"sex":57,"minAge":58,"maxAge":10,"enrollmentInfo":59,"targetDuration":62,"studyType":63,"phases":10,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Biomedical Research Foundation, Academy of Athens","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Group A: Belimumab",null,"Group A will consist of patients under treatment with belimumab.",{"label":13,"type":10,"description":14,"interventionNames":10},"Group B: Standard-of-care (follow-up after May 1st 2014)","Group B will consist of patients on standar-of-care SLE treatment, who were followed-up after May 1st 2014 (the first date where belimumab was available in Greece).",{"label":16,"type":10,"description":17,"interventionNames":10},"Group C: Standar-of-care (follow-up before May 1st 2014)","Group C will consist of a historical cohort of patients under standar-of-care, followed-up before May 1st 2014 (the first date where belimumab was available in Greece).",[19,24],{"name":20,"role":21,"phone":22,"phoneExt":10,"email":23},"Dimitrios T. Boumpas, Professor in Medicine","CONTACT","00306937212025","boumpasd@uoc.gr",{"name":25,"role":21,"phone":26,"phoneExt":10,"email":27},"Antonis Fanouriakis, Ass. Professor in Medicine","00306973016540","afanour@med.uoa.gr",[29],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"University Hospital 'Attikon'","RECRUITING","Athens","Attica","12462","Greece","GR",{"type":38,"coordinates":39},"Point",[40,41],23.72784,37.98376,{"lat":41,"lon":40},[44,46],{"name":45,"role":21,"phone":22,"phoneExt":10,"email":23},"Dimitrios T Boumpas, Professor in Medicine",{"name":45,"role":47,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"type":47,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"DIMITRIOS BOUMPAS","Professor in Medicine","100597294","does-belimumab-modify-the-natural-history-of-sle-a-propensity-score-matched-real-world-study-100597294",false,"NCT07056621","Does Belimumab Modify the Natural History of SLE? A Propensity Score-matched, Real-world Study","Inclusion Criteria:\n\n* Systemic lupus erythematosus classification according to the Systemic Lupus International Collaborating Clinics (SLICC) criteria\n* Age ≥ 18 years old\n* Time of follow-up ≥ 6 months\n* Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥ 4\n* Physician Global Assessment (PGA) visual analogue score \\> 1\n\nExclusion Criteria:\n\n* Patients with incomplete medical records or missing key variables\n* Patients with concomitant autoimmune disorders (excluding thyroid disease)","ALL","18 Years",{"count":60,"type":61},684,"ESTIMATED","1 Year","OBSERVATIONAL","This will be a combined retrospective and prospective cohort study, that will evaluate the incidence of de novo Systemic Lupus Erythematosus major organ manifestations (defined as BILAG A flares) in patients receiving belimumab (Arm A) and compare it to 2 standard-of-care groups (SoC) (Arm B: patients on SoC; Arm C: patients on SoC followed-up up to May 1st 2014, the first date where belimumab was available in Greece).\n\nThe investigators will utilize survival analysis methods (Kaplan-Meier survival curves and Cox regression) and mixed effects longitudinal analyses. Additionally, the investigators will employ propensity score matching and\u002For inverse probability of treatment weighting, to create balanced cohorts and reduce bias.",[66],"SLE - Systemic Lupus Erythematosus",[68,69,70],"SLE","belimumab","bilag","2025-09-01",{"date":73,"type":74},"2025-09-08","ACTUAL",{"date":76,"type":74},"2025-06-30",{"date":78,"type":61},"2026-06",{"name":5,"class":6},1]