[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655675":3},{"organization":4,"outcomesModule":7,"designInfo":57,"detailedDescription":61,"studyPopulation":62,"armGroups":63,"interventions":69,"overallOfficials":75,"centralContacts":80,"locations":88,"responsibleParty":107,"collaborators":58,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":111,"sex":117,"minAge":118,"maxAge":58,"enrollmentInfo":119,"targetDuration":58,"studyType":122,"phases":58,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":91,"whyStopped":58,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"European EGPA Study Group","NETWORK",{"primaryOutcomes":8,"secondaryOutcomes":24,"otherOutcomes":44},[9,13,17,21],{"measure":10,"description":11,"timeFrame":12},"Complete Response","Proportion of patients achieving complete response during follow-up. Complete response is defined as no disease activity (BVAS=0) and oral corticosteroid dose ≤4.0 mg\u002Fday.","Baseline and up to 24 months (at 3, 6, 12, 24 months)",{"measure":14,"description":15,"timeFrame":16},"Change in Lung Function","Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) from baseline to each follow-up time point.\n\nUnit of Measure: Milliliters","Baseline, 3, 6, 12, and 24 months",{"measure":18,"description":19,"timeFrame":20},"Disease relapse","Proportion of patients experiencing disease relapse after achieving complete response. Relapse is defined as active vasculitis, BVAS \\>0, and\u002For worsening asthma or ear-nose-throat manifestations leading to an increase in oral corticosteroid dose to \\>4.0 mg\u002Fday, initiation of a new immunosuppressive therapy, or hospitalization.","3, 6, 12, and 24 months",{"measure":22,"description":23,"timeFrame":12},"Partial response","Proportion of patients achieving complete response during follow-up. Partial response is defined as no disease activity (BVAS=0) and oral corticosteroid dose \\>4.0 mg\u002Fday.",[25,28,31,34,37,41],{"measure":26,"description":27,"timeFrame":20},"Treatment persistence","Proportion of patients who continue benralizumab treatment, switch benralizumab dosage, or discontinue benralizumab for any reason.",{"measure":29,"description":30,"timeFrame":16},"Change in oral corticosteroid dose expressed as prednisone-equivalent dose","The daily dose of each oral corticosteroid will be converted to prednisone-equivalent mg\u002Fday using standardized glucocorticoid equivalence factors.\n\nUnit of Measure: mg\u002Fday of prednisone equivalent",{"measure":32,"description":33,"timeFrame":20},"Oral corticosteroid discontinuation","Proportion of patients who discontinue oral corticosteroid therapy during follow-up.",{"measure":35,"description":36,"timeFrame":16},"Overall clinical benefit in first-line versus post-mepolizumab patients","A comparison of the overall clinical benefit in patients treated with benralizumab as first-line therapy versus patients switching to benralizumab following prior exposure to mepolizumab.\n\nUnit of Measure: Percentage of participants",{"measure":38,"description":39,"timeFrame":40},"Effectiveness after benralizumab dosage switching","Assessment of complete response, partial response, and changes in lung function in patients switching benralizumab dosage from 30 mg every 4 weeks to 30 mg every 8 weeks or from 30 mg every 8 weeks to 30 mg every 4 weeks.","3 months after dosage switch",{"measure":42,"description":43,"timeFrame":20},"Adverse event rate","Proportion of patients experiencing at least one adverse event during benralizumab treatment, regardless of causal association with treatment.",[45,48,51,54],{"measure":46,"description":47,"timeFrame":16},"Changes in organ manifestations","Change in the proportion of patients with active EGPA-related organ manifestations assessed separately from Birmingham Vasculitis Activity Score items.",{"measure":49,"description":50,"timeFrame":20},"DMARD discontinuation rate","Proportion of patients discontinuing disease-modifying antirheumatic drug treatment that was ongoing or newly started at baseline.",{"measure":52,"description":53,"timeFrame":16},"Change in ANCA positivity","Change in the proportion of patients with positive ANCA testing and proportion of patients with ANCA negativization among those who were ANCA-positive at baseline.",{"measure":55,"description":56,"timeFrame":16},"Change in eosinophil count","Change in blood eosinophil count from baseline to each follow-up time point.",{"allocation":58,"interventionModel":58,"interventionModelDescription":58,"primaryPurpose":58,"observationalModel":59,"timePerspective":60,"maskingInfo":58},null,"COHORT","OTHER","BELONG-EGPA is a multicenter, retro-prospective observational study conducted within centers belonging to the European EGPA Study Group. The study is designed to evaluate the long-term real-world effectiveness and safety of benralizumab in adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).\n\nThe study population will include adult patients with EGPA who meet the 2022 American College of Rheumatology\u002FEuropean Alliance of Associations for Rheumatology classification criteria for EGPA or the criteria proposed in the MIRRA trial, and who receive benralizumab 30 mg every 4 weeks. Only patients with at least 3 months of available follow-up after starting benralizumab will be included.\n\nDemographic, clinical, biological, lung function, and treatment-related data will be collected from medical charts through a standardized electronic case report form. Data will be collected at the start of benralizumab treatment and at 3, 6, 12, and 24 months of follow-up.\n\nThe primary effectiveness outcomes include achievement of complete response and partial response, changes in lung function measured by pre-bronchodilator FEV1, and disease relapses. Complete response is defined as no disease activity, with Birmingham Vasculitis Activity Score equal to 0, and an oral corticosteroid dose of 4.0 mg\u002Fday or less of prednisone, prednisolone, or equivalent. Partial response is defined as no disease activity with an oral corticosteroid dose greater than 4.0 mg\u002Fday.\n\nSecondary outcomes include treatment persistence, oral corticosteroid tapering and discontinuation, effectiveness and safety in first-line patients compared with patients previously exposed to mepolizumab, outcomes after benralizumab dosage switching, and adverse events and serious adverse events during treatment.\n\nAdditional outcomes include changes in organ manifestations, discontinuation of disease-modifying antirheumatic drugs, changes in ANCA status, and variation in eosinophil count. All data will be anonymized and stored in a centralized database.","Adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) treated with benralizumab 30 mg every 4 weeks at EGPA referral centers participating in the European EGPA Study Group. Patients may be newly diagnosed or have relapsing or refractory EGPA, and will be included if at least 3 months of follow-up data after benralizumab initiation are available.",[64],{"label":65,"type":58,"description":66,"interventionNames":67},"Patients with EGPA treated with benralizumab","Adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) receiving benralizumab 30 mg every 4 weeks in a real-world setting. Patients may be newly diagnosed or have relapsing or refractory EGPA and must have at least 3 months of available follow-up after starting benralizumab.",[68],"Biological: Benralizumab 30 mg\u002Fml",[70],{"type":71,"name":72,"description":73,"armGroupLabels":74,"otherNames":58},"BIOLOGICAL","Benralizumab 30 mg\u002Fml","Benralizumab administered at a dose of 30 mg every 4 weeks in adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) in a real-world setting. Patients may receive benralizumab as first-line biologic therapy or after previous exposure to mepolizumab. Treatment use, persistence, dosage changes, effectiveness outcomes, and safety events will be assessed during follow-up.",[65],[76],{"name":77,"affiliation":78,"role":79},"Giacomo Emmi, MD\u002FPhD","University of Trieste, Italy","PRINCIPAL_INVESTIGATOR",[81,85],{"name":77,"role":82,"phone":83,"phoneExt":58,"email":84},"CONTACT","+393286852815","giacomo.emmi0105@gmail.com",{"name":86,"role":82,"phone":58,"phoneExt":58,"email":87},"Irene Mattioli, PharmD\u002FPhD","irene.mattioli@unifi.it",[89],{"facility":90,"status":91,"city":92,"state":93,"zip":94,"country":93,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"Edoardo Biancalana","RECRUITING","Florence","Italy","50134","IT",{"type":97,"coordinates":98},"Point",[99,100],11.24626,43.77925,{"lat":100,"lon":99},[103],{"name":104,"role":82,"phone":105,"phoneExt":58,"email":106},"Edoardo Biancalana, MD","+393287394992","edoardo.biancalana@unifi.it",{"type":108,"investigatorFullName":58,"investigatorTitle":58,"investigatorAffiliation":58,"oldNameTitle":58,"oldOrganization":58},"SPONSOR","100655675","benralizumab-effectiveness-in-egpa-100655675",false,"NCT07815886","Benralizumab Effectiveness in EGPA","Benralizumab Effectiveness in the LONG-term Real-life Setting in EGPA: The BELONG-EGPA Study","BELONG-EGPA","Inclusion Criteria:\n\n* Age 18 years or older.\n* Diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) according to the 2022 American College of Rheumatology\u002FEuropean Alliance of Associations for Rheumatology classification criteria or the criteria proposed in the MIRRA trial.\n* Treatment with benralizumab 30 mg every 4 weeks.\n* At least 3 months of available follow-up data after starting benralizumab.\n* Written informed consent for study participation and data collection.\n\nExclusion Criteria:\n\n* Age younger than 18 years.\n* No available follow-up data after starting benralizumab.\n* Follow-up after benralizumab initiation shorter than 3 months.\n* Lack of written informed consent, where required by local regulations.","ALL","18 Years",{"count":120,"type":121},100,"ESTIMATED","OBSERVATIONAL","This is a multicenter, retro-prospective observational study evaluating the effectiveness and safety of benralizumab in adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) in a real-world setting. The study will include patients treated with benralizumab 30 mg every 4 weeks at EGPA referral centers participating in the European EGPA Study Group. Clinical, laboratory, lung function, treatment, relapse, and safety data will be collected from medical charts at baseline and during follow-up up to 24 months.",[125],"Eosinophilic Granulomatosis With Polyangiitis (EGPA)",[127,128,129,130,131],"Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss)","EGPA","Real-world study","Benralizumab","Vasculitis","2026-09-08",{"date":134,"type":135},"2026-09-11","ACTUAL",{"date":137,"type":135},"2026-02-11",{"date":139,"type":121},"2028-02-11",{"name":5,"class":6},1]