[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556625":3},{"organization":4,"outcomesModule":7,"designInfo":57,"detailedDescription":63,"studyPopulation":56,"armGroups":64,"interventions":77,"overallOfficials":56,"centralContacts":85,"locations":91,"responsibleParty":107,"collaborators":56,"id":111,"slug":56,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":112,"sex":118,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":56,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":94,"whyStopped":56,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Universita di Verona","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":56},[9],{"measure":10,"description":11,"timeFrame":12},"micro RNA (miRNA)","Fold increase in miRNA intensity measurements on the base-two logarithmic scale","12 weeks",[14,17,20,23,26,29,32,35,38,41,44,47,50,53],{"measure":15,"description":16,"timeFrame":12},"Proteomic profile","Fold increase in proteins intensity measurements on the base-two logarithmic scale",{"measure":18,"description":19,"timeFrame":12},"American College of Rheumatology 20% Improvement (ACR20)","Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12",{"measure":21,"description":22,"timeFrame":12},"Health Assessment Questionnaire-Disability Index (HAQ-DI)","Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 (range 0.000 - 3.000, higher numbers are worse)",{"measure":24,"description":25,"timeFrame":12},"Disease Activity Score 28 joints measured with CRP (DAS28-CRP)","Change From Baseline in Disease Activity Score 28 joints measured with CRP (DAS28-CRP) at Weeks 12 (range 0.96 - 8.61, higher numbers are worse)",{"measure":27,"description":28,"timeFrame":12},"36-Item Short Form Survey (SF-36)","Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12 (range 0 - 100, lower numbers are worse)",{"measure":30,"description":31,"timeFrame":12},"Functional Assessment of Chronic Illness Therapy (FACIT)","Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12 (range 0 - 52, lower numbers are worse)",{"measure":33,"description":34,"timeFrame":12},"American College of Rheumatology 50% Improvement (ACR50)","Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 12",{"measure":36,"description":37,"timeFrame":12},"Tender Joint Count","Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 12",{"measure":39,"description":40,"timeFrame":12},"Swollen Joint Count","Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 12",{"measure":42,"description":43,"timeFrame":12},"Subject's Global Assessment of Disease Activity (SGA)","Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 12 (range 0 - 10, higher numbers are worse)",{"measure":45,"description":46,"timeFrame":12},"Physician's Global Assessment of Disease Activity (PGA)","Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 12 (range 0 - 10, higher numbers are worse)",{"measure":48,"description":49,"timeFrame":12},"Pain on Numeric Rating Scale (NRS)","Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 12 (range 0 - 10, higher numbers are worse)",{"measure":51,"description":52,"timeFrame":12},"Clinical Disease Activity Index (CDAI)","Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 12 (range 0 - 76, higher numbers are worse)",{"measure":54,"description":55,"timeFrame":12},"Simplified Disease Activity Index (SDAI)","Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 12 (range 0 - 91, higher numbers are worse)",null,{"allocation":58,"interventionModel":59,"interventionModelDescription":56,"primaryPurpose":60,"observationalModel":56,"timePerspective":56,"maskingInfo":61},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":62,"maskingDescription":56,"whoMasked":56},"NONE","Population:\n\nThe study will include 30 patients with active rheumatoid arthritis: 15 patients treated with Filgotinib. 15 patients treated with Adalimumab (used as a comparison group).\n\nProcedures:\n\nParticipants will have blood samples taken at the start and then every 4 weeks up to 12 weeks. These samples will be used to analyze changes in proteins and micro-RNA. Participants will continue their regular rheumatoid arthritis treatment during the study.\n\nPrimary Objective:\n\nTo observe changes in the metabolic profile (proteins and micro-RNA) in patients treated with Filgotinib.\n\nSecondary Objectives:\n\nCompare the metabolic profile changes between Filgotinib and Adalimumab. Identify metabolic factors associated with early clinical response to Filgotinib.\n\nSafety and Data Management:\n\nAdverse events will be monitored and reported. Patient confidentiality will be maintained according to privacy laws.\n\nStudy Duration:\n\nRecruitment: 16 weeks. Patient involvement: 12 weeks. Total study duration: 28 weeks.",[65,71],{"label":66,"type":67,"description":68,"interventionNames":69},"Filgotinib","EXPERIMENTAL","Filgotinib 200 mg qd",[70],"Drug: Filgotinib",{"label":72,"type":73,"description":74,"interventionNames":75},"Adalimumab","ACTIVE_COMPARATOR","Adalimumab 40 mg q2wk",[76],"Drug: Adalimumab",[78,82],{"type":79,"name":66,"description":80,"armGroupLabels":81,"otherNames":56},"DRUG","Patients will receive pills of Filgotinib 200 mg qd for 12 weeks",[66],{"type":79,"name":72,"description":83,"armGroupLabels":84,"otherNames":56},"Patients will receive subcutaneous injections of Adalimumab 40 mg q2wk for 12 weeks",[72],[86],{"name":87,"role":88,"phone":89,"phoneExt":56,"email":90},"Giovanni Adami, MD","CONTACT","+390458122574","giovanni.adami@univr.it",[92],{"facility":93,"status":94,"city":95,"state":56,"zip":96,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":104,"contacts":105},"Rheumatology Section, University of Verona","RECRUITING","Verona","37100","Italy","IT",{"type":100,"coordinates":101},"Point",[102,103],10.9938,45.43854,{"lat":103,"lon":102},[106],{"name":87,"role":88,"phone":89,"phoneExt":56,"email":90},{"type":108,"investigatorFullName":109,"investigatorTitle":110,"investigatorAffiliation":5,"oldNameTitle":56,"oldOrganization":56},"PRINCIPAL_INVESTIGATOR","Giovanni Adami","Principal Investigator","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":122,"type":123},30,"ESTIMATED","INTERVENTIONAL",[126],"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.",[129],"Rheumatoid Arthritis",[131],"RA","2024-07-30",{"date":134,"type":135},"2024-08-01","ACTUAL",{"date":137,"type":135},"2024-07-15",{"date":139,"type":123},"2025-09-15",{"name":5,"class":6},1]