[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556625":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":51,"collaborators":25,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Universita di Verona","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Filgotinib","EXPERIMENTAL","Filgotinib 200 mg qd",[13],"Drug: Filgotinib",{"label":15,"type":16,"description":17,"interventionNames":18},"Adalimumab","ACTIVE_COMPARATOR","Adalimumab 40 mg q2wk",[19],"Drug: Adalimumab",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Patients will receive pills of Filgotinib 200 mg qd for 12 weeks",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Patients will receive subcutaneous injections of Adalimumab 40 mg q2wk for 12 weeks",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Giovanni Adami, MD","CONTACT","+390458122574","giovanni.adami@univr.it",[36],{"facility":37,"status":38,"city":39,"state":25,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Rheumatology Section, University of Verona","RECRUITING","Verona","37100","Italy","IT",{"type":44,"coordinates":45},"Point",[46,47],10.9938,45.43854,{"lat":47,"lon":46},[50],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Giovanni Adami","Principal Investigator","100556625","phase-4-filgotinib-effect-on-proteomic-profile-and-micro-rna-expression-in-patients-with-active-rheumatoid-arthritis-ra-100556625",false,"NCT06527534","Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoid Arthritis (RA)","Exploring the Effects of Filgotinib, an Oral JAK-1 Selective Inhibitor, Proteomic Profile and Micro-RNA Expression in Peripheral Blood Mononuclear Cell (PBMC) of Patients With Active Rheumatoid Arthritis (RA)","FILRA","Inclusion criteria\n\n* Rheumatoid arthritis (RA) according to ACR\u002FEULAR 2010 criteria with active disease (Disease Activity Score 28-joints C-reactive protein \\[DAS28 CRP\\] \\>5.1 and\u002For Clinical Disease Activity Index \\[CDAI\\] \\>22)\n* Age \\> 18, \\\u003C65 years\n* Patients for whom treatment with filgotinib or adalimumab might be planned\n\nExclusion criteria\n\n* History of major cardiovascular events or stroke\n* History of venous thromboembolism\n* Active smokers or past smokers \\>10 pack\u002Fyears\n* History of fragility fractures or severe osteoporosis (T score at total hip or femoral neck or lumbar spine ≤3.5)\n* Treatment with bone-active medications (estrogens, bisphosphonates, denosumab, teriparatide, romosozumab)\n* Chronic treatment with moderate to high dose of glucocorticoids (≥7.5 mg\u002Fday of prednisone equivalent for more than 3 months prior to enrollment), short term (\\\u003C3 months) will be accepted if tapered, as clinically feasible, to \\\u003C7.5 mg\u002Fday before enrollment)","ALL","18 Years","65 Years",{"count":67,"type":68},30,"ESTIMATED","INTERVENTIONAL",[71],"PHASE4","Purpose:\n\nThe study aims to investigate how Filgotinib affects proteins and micro-RNA in the blood of patients with rheumatoid arthritis. This could help understand its impact on inflammation and bone health in these patients.\n\nStudy Design:\n\nThis is a single-center, prospective randomized study.",[74],"Rheumatoid Arthritis",[76],"RA","2024-07-30",{"date":79,"type":80},"2024-08-01","ACTUAL",{"date":82,"type":80},"2024-07-15",{"date":84,"type":68},"2025-09-15",{"name":5,"class":6},1]