[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546681":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":41,"centralContacts":45,"locations":56,"responsibleParty":222,"collaborators":224,"id":228,"slug":229,"hasResults":230,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":230,"sex":236,"minAge":237,"maxAge":12,"enrollmentInfo":238,"targetDuration":12,"studyType":241,"phases":242,"briefSummary":244,"conditions":245,"keywords":247,"overallStatus":59,"whyStopped":12,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":259},{"fullName":5,"class":6},"University Hospital, Ghent","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard dosing of biologics","NO_INTERVENTION","Patients will receive biological therapy according to standard clinical practice. Secukinumab, ixekizumab and guselkumab will be administered according to standard dosing regimen. Adjustments in doses and intervals, or biological switch according to clinical parameters or at the physicians' discretion are considered as standard clinical practice.\n\nInvestigators will not have access to information on levels of the drug or antidrug antibodies and no decision tree will be provided to guide treatment adjustments.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Proactive TDM based dosing","EXPERIMENTAL","Stepwise treatment modifications based on drug levels: if the drug level is below\u002Fabove the target the dose of the biologic will be increased\u002Fdecreased by stepwise interval shortening\u002Flengthening - first modified by 33% and then 50% increase or decrease. If the target is still not reached at the next study visit, the dosing interval will be shortened or prolonged with one additional week at each additional visit until the target is reached.\n\nIn case the dosing regimen shifts from dose increase to dose decrease or vice versa, the dosing interval will be shortened or prolonged with one additional week at each additional visit until the target is reached.",[18,19,20],"Drug: Proactive TDM-based dosing of secukinumab","Drug: Proactive TDM-based dosing of ixekizumab","Drug: Proactive TDM-based dosing of guselkumab",[22,29,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Proactive TDM-based dosing of secukinumab","Maintenance\u002Fnormal dose is 300 mg\u002F4 weeks or 300 mg\u002F month\n\nFirst dose reduction step: 300 mg\u002F6 weeks. Second dose reduction step: 300 mg\u002F8 weeks. Further dose reduction steps: prolongation with 1 additional week\n\nFirst dose escalation step: 300 mg\u002F3 weeks Second dose escalation step: 300 mg\u002F2 weeks Further dose escalation step: shortening with 1 additional week",[14],[28],"Cosentyx",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Proactive TDM-based dosing of ixekizumab","Maintenance\u002Fnormal dose is 80 mg\u002F4 weeks.\n\nFirst dose reduction step: 80 mg\u002F6 weeks. Second dose reduction step: 80 mg\u002F8 weeks Further dose reduction steps: prolongation with 1 additional week\n\nFirst dose escalation step: 80 mg\u002F3 weeks Second dose escalation step: 80 mg\u002F2 weeks Further dose escalation step: shortening with 1 additional week",[14],[34],"Taltz",{"type":23,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Proactive TDM-based dosing of guselkumab","Maintenance\u002Fnormal dose is 100 mg\u002F8 weeks.\n\nFirst dose reduction step: 100 mg\u002F12 weeks. Second dose reduction step: 100 mg\u002F16 weeks. Further dose reduction steps: prolongation with 1 additional week\n\nFirst dose escalation step: 100 mg\u002F6 weeks Second dose escalation step: 100 mg\u002F4 weeks Further dose escalation step: shortening with 1 additional week",[14],[40],"Tremfya",[42],{"name":43,"affiliation":5,"role":44},"Jo Lambert, Prof.","PRINCIPAL_INVESTIGATOR",[46,52],{"name":47,"role":48,"phone":49,"phoneExt":50,"email":51},"Jo Lambert, Prof","CONTACT","093322298","+32","jo.lambert@uzgent.be",{"name":53,"role":48,"phone":54,"phoneExt":50,"email":55},"Rani Soenen, Dr.","093326541","rani.soenen@uzgent.be",[57,74,88,94,105,115,123,137,149,161,169,178,190,202,210],{"facility":58,"status":59,"city":60,"state":12,"zip":12,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"AZ Sint-Jan","RECRUITING","Bruges","Belgium","BE",{"type":64,"coordinates":65},"Point",[66,67],3.22424,51.20892,{"lat":67,"lon":66},[70,72],{"name":71,"role":48,"phone":12,"phoneExt":12,"email":12},"Els Wittouck",{"name":73,"role":44,"phone":12,"phoneExt":12,"email":12},"Els Wittouck, Dr.",{"facility":75,"status":59,"city":76,"state":12,"zip":77,"country":61,"countryCode":62,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"CHU Saint-Pierre","Brussels","1000",{"type":64,"coordinates":79},[80,81],4.34878,50.85045,{"lat":81,"lon":80},[84,86],{"name":85,"role":48,"phone":12,"phoneExt":12,"email":12},"Jonathan Krygier",{"name":87,"role":44,"phone":12,"phoneExt":12,"email":12},"Jonathan Krygier, Dr.",{"facility":89,"status":90,"city":76,"state":12,"zip":12,"country":61,"countryCode":62,"cosmosGeoPoint":91,"geoPoint":93,"contacts":12},"UCL Saint-Luc","ACTIVE_NOT_RECRUITING",{"type":64,"coordinates":92},[80,81],{"lat":81,"lon":80},{"facility":95,"status":96,"city":76,"state":12,"zip":12,"country":61,"countryCode":62,"cosmosGeoPoint":97,"geoPoint":99,"contacts":100},"ULB Erasme","NOT_YET_RECRUITING",{"type":64,"coordinates":98},[80,81],{"lat":81,"lon":80},[101,103],{"name":102,"role":48,"phone":12,"phoneExt":12,"email":12},"Farida Benhadou",{"name":104,"role":44,"phone":12,"phoneExt":12,"email":12},"Farida Benhadou, Dr.",{"facility":106,"status":59,"city":76,"state":12,"zip":12,"country":61,"countryCode":62,"cosmosGeoPoint":107,"geoPoint":109,"contacts":110},"UZ Brussel",{"type":64,"coordinates":108},[80,81],{"lat":81,"lon":80},[111,113],{"name":112,"role":48,"phone":12,"phoneExt":12,"email":12},"Jan Gutermuth",{"name":114,"role":44,"phone":12,"phoneExt":12,"email":12},"Valerie Reynaert, Prof.",{"facility":116,"status":90,"city":117,"state":12,"zip":12,"country":61,"countryCode":62,"cosmosGeoPoint":118,"geoPoint":122,"contacts":12},"Grand Hôpital de Charleroi","Charleroi",{"type":64,"coordinates":119},[120,121],4.44448,50.41136,{"lat":121,"lon":120},{"facility":124,"status":59,"city":125,"state":12,"zip":126,"country":61,"countryCode":62,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"AZ Alma","Eeklo","9900",{"type":64,"coordinates":128},[129,130],3.55654,51.18703,{"lat":130,"lon":129},[133,136],{"name":134,"role":48,"phone":12,"phoneExt":12,"email":135},"Soetkin Desmet, Dr.","secr.dermato@azalma.be",{"name":134,"role":44,"phone":12,"phoneExt":12,"email":12},{"facility":138,"status":59,"city":139,"state":12,"zip":12,"country":61,"countryCode":62,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Dermatologiepraktijk huidziekten Geel","Geel",{"type":64,"coordinates":141},[142,143],4.98917,51.16557,{"lat":143,"lon":142},[146,148],{"name":147,"role":48,"phone":12,"phoneExt":12,"email":12},"Hugo Boonen, Dr.",{"name":147,"role":44,"phone":12,"phoneExt":12,"email":12},{"facility":150,"status":59,"city":151,"state":12,"zip":12,"country":61,"countryCode":62,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"AZ Maria Middelares","Ghent",{"type":64,"coordinates":153},[154,155],3.71667,51.05,{"lat":155,"lon":154},[158,160],{"name":159,"role":48,"phone":12,"phoneExt":12,"email":12},"Veerle Dhondt, Dr.",{"name":159,"role":44,"phone":12,"phoneExt":12,"email":12},{"facility":162,"status":59,"city":151,"state":12,"zip":12,"country":61,"countryCode":62,"cosmosGeoPoint":163,"geoPoint":165,"contacts":166},"UZ Gent",{"type":64,"coordinates":164},[154,155],{"lat":155,"lon":154},[167,168],{"name":43,"role":48,"phone":12,"phoneExt":12,"email":12},{"name":43,"role":44,"phone":12,"phoneExt":12,"email":12},{"facility":170,"status":171,"city":172,"state":12,"zip":12,"country":61,"countryCode":62,"cosmosGeoPoint":173,"geoPoint":177,"contacts":12},"Clinique André Renard","WITHDRAWN","Herstal",{"type":64,"coordinates":174},[175,176],5.62346,50.66415,{"lat":176,"lon":175},{"facility":179,"status":59,"city":180,"state":12,"zip":12,"country":61,"countryCode":62,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Dermatologie Handelskaai","Kortrijk",{"type":64,"coordinates":182},[183,184],3.26487,50.82803,{"lat":184,"lon":183},[187,189],{"name":188,"role":48,"phone":12,"phoneExt":12,"email":12},"Erwin Suys, Dr.",{"name":188,"role":44,"phone":12,"phoneExt":12,"email":12},{"facility":191,"status":59,"city":192,"state":12,"zip":12,"country":61,"countryCode":62,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"UZ Leuven","Leuven",{"type":64,"coordinates":194},[195,196],4.70093,50.87959,{"lat":196,"lon":195},[199,201],{"name":200,"role":48,"phone":12,"phoneExt":12,"email":12},"Tom Hillary, Dr.",{"name":200,"role":44,"phone":12,"phoneExt":12,"email":12},{"facility":203,"status":90,"city":204,"state":12,"zip":12,"country":61,"countryCode":62,"cosmosGeoPoint":205,"geoPoint":209,"contacts":12},"CHU Liège","Liège",{"type":64,"coordinates":206},[207,208],5.56749,50.63373,{"lat":208,"lon":207},{"facility":211,"status":59,"city":212,"state":12,"zip":12,"country":61,"countryCode":62,"cosmosGeoPoint":213,"geoPoint":217,"contacts":218},"Dermatologie Maldegem","Maldegem",{"type":64,"coordinates":214},[215,216],3.44511,51.20737,{"lat":216,"lon":215},[219,221],{"name":220,"role":48,"phone":12,"phoneExt":12,"email":12},"Sven Lanssens, Dr.",{"name":220,"role":44,"phone":12,"phoneExt":12,"email":12},{"type":223,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[225],{"name":226,"class":227},"Belgium Health Care Knowledge Centre","OTHER_GOV","100546681","phase-4-proactive-tdm-versus-standard-use-of-biologics-in-psoriasis-100546681",false,"NCT06398106","Proactive TDM Versus Standard Use of Biologics in Psoriasis","Proactive Therapeutic Drug Monitoring Versus Routine Care With the Novel Biologics in Psoriasis : a Pragmatic, Multicentric, Randomised, Controlled Study","HELIOS","Inclusion Criteria:\n\n1. Adults; aged 18 years or older\n2. Documented diagnosis of psoriasis (predominantly type vulgaris; based on clinical diagnosis) by an accredited dermatologist\n3. Patients must be currently treated with secukinumab, ixekizumab or guselkumab ≥ 6 months according to the standard dosing scheme.\n4. The subject signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures\n\nExclusion Criteria:\n\n1. Another indication than plaque psoriasis as the main indication for biologic use (e.g. receives biologic for rheumatoid arthritis as the main indication)\n2. Concomitant use of systemic immunosuppressants other than methotrexate or acitretin (e.g. prednisone, cyclosporine etc)\n3. Severe comorbidities with short life-expectancy (e.g. metastasized tumour) or uncontrolled PsA at inclusion\u002Fbaseline\n4. Presumed inability to follow the study protocol\n5. Active pregnancy wish","ALL","18 Years",{"count":239,"type":240},210,"ESTIMATED","INTERVENTIONAL",[243],"PHASE4","Biologics are effective agents for the treatment of psoriasis. The newest generation of biologics block interleukin 17 and 23. Physicians always prescribe these drugs in a fixed dose, but this may lead to under- and overdosing in some patients. Underdosing may lead to inadequate response or loss of response over time. Overdosage, on the other hand, can lead to higher risk of side effects and higher costs for the healthcare system. In daily clinical practice, physicians often tackle this real-world issue by blind trial- and- error dose modifications or switching to another biologic. In this study, we want to rationalize these dose modifications and optimize dosing based on the drug concentrations, measured in the blood of the patient (i.e. therapeutic drug monitoring). Depending on the drug concentration, the interval between injections will be lengthened or shortened with the aim to reach the required drug concentration to reach the best clinical result. The trial will be conducted in 14 Belgian hospitals where patients will be divided into 2 study groups: a group that will be advised on the dosing scheme of their biologic based on the measured drug concentration and a group that continues dosing as in daily clinical practice. We will monitor if the clinical response and quality of life remains stable. With this study, we will track drug concentrations as we believe that they can guide dosing of biologics and we hope to achieve better safety, lower healthcare expenses and higher patients' treatment satisfaction while striving for the best clinical response.",[246],"Psoriasis Vulgaris",[248,249],"Therapeutic drug monitoring","Biologics","2026-03-02",{"date":252,"type":253},"2026-03-04","ACTUAL",{"date":255,"type":253},"2024-12-20",{"date":257,"type":240},"2028-03-01",{"name":5,"class":6},15]