[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100461681":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":40,"responsibleParty":186,"collaborators":23,"id":189,"slug":190,"hasResults":191,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":191,"sex":197,"minAge":198,"maxAge":23,"enrollmentInfo":199,"targetDuration":23,"studyType":202,"phases":203,"briefSummary":205,"conditions":206,"keywords":208,"overallStatus":43,"whyStopped":23,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":220},{"fullName":5,"class":6},"Diakonhjemmet Hospital","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Conventional treat-to-target","Conventional treat-to-target follow-up strategy with structured clinical assessment of disease activity",[12],"Other: Conventional treat-to-target",{"label":14,"type":15,"description":16,"interventionNames":17},"Imaging informed treat-to-target","EXPERIMENTAL","Imaging informed treat-to-target follow-up strategy with both structured clinical assessment of disease activity and structured imaging assessment of disease activity.",[18],"Other: Imaging informed treat-to-target",[20,24],{"type":6,"name":14,"description":21,"armGroupLabels":22,"otherNames":23},"A treat-to-target treatment strategy incorporating information from ultrasound assessment of joints, tendons and entheses (at every visit), and magnetic resonance imaging (MRI) of spine and sacroiliac (SI)-joints at baseline and 1 year, in addition to clinical information\n\nSpecifically, this means that these additional measures will be added to conventional treat to target:\n\n* If evidence of enthesitis (power Doppler\\>0 in enthesis) or axial inflammation (SPARCC score ≥ 2\\* in SI-joint or SPARCC score ≥ 5 in presence of clinical symptoms of axial disease) on imaging the patient will progress directly to biological disease modifying antirheumatic drug in the treatment algorithm\n* If evidence of ongoing inflammation (power Doppler\\>0) on ultrasound assessment of joints, tendons or enthesis, the patient will be classified as not having reached their treatment target",[14],null,{"type":6,"name":9,"description":25,"armGroupLabels":26,"otherNames":23},"Patients are treated according to an algorithm based on current European recommendations. The conventional treatment target, applicable to both arms and the target in the conventional arm, is all of: Disease Activity index in PSoriatic Arthritis (DAPSA) remission (≤4), Enthesitis ≤1, Psoriasis Body Surface Area ≤3%",[9],[28],{"name":29,"affiliation":30,"role":31},"Siri Lillegraven, MD, MPH, PhD","Diakonhjemmet","PRINCIPAL_INVESTIGATOR",[33,37],{"name":29,"role":34,"phone":35,"phoneExt":23,"email":36},"CONTACT","+4722451500","siri.lillegraven@diakonsyk.no",{"name":38,"role":34,"phone":23,"phoneExt":23,"email":39},"Even Lillejordet, MD","even.lillejordet@diakonsyk.no",[41,57,69,81,92,104,115,127,139,151,163,174],{"facility":42,"status":43,"city":44,"state":23,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Department of Rheumatology, Helse Møre og Romsdal HF","RECRUITING","Ålesund","6026","Norway","NO",{"type":49,"coordinates":50},"Point",[51,52],6.15492,62.47225,{"lat":52,"lon":51},[55],{"name":56,"role":34,"phone":23,"phoneExt":23,"email":23},"Maud-Kristine Aga Ljoså, MD",{"facility":58,"status":43,"city":59,"state":23,"zip":60,"country":46,"countryCode":47,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Department of Rheumatology, Haukeland University Hospital, Helse Bergen HF","Bergen","5021",{"type":49,"coordinates":62},[63,64],5.32415,60.39299,{"lat":64,"lon":63},[67],{"name":68,"role":34,"phone":23,"phoneExt":23,"email":23},"Bjørg-Tilde Fevang, MD PhD",{"facility":70,"status":43,"city":71,"state":23,"zip":72,"country":46,"countryCode":47,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Department of Rheumatology, Drammen Hospital, Vestre Viken HF","Drammen","3004",{"type":49,"coordinates":74},[75,76],10.20449,59.74389,{"lat":76,"lon":75},[79],{"name":80,"role":34,"phone":23,"phoneExt":23,"email":23},"Ada S. Wierød, MD",{"facility":82,"status":43,"city":83,"state":23,"zip":23,"country":46,"countryCode":47,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Helse Førde","Førde",{"type":49,"coordinates":85},[86,87],5.85717,61.45217,{"lat":87,"lon":86},[90],{"name":91,"role":34,"phone":23,"phoneExt":23,"email":23},"Anja Myhre Hjelle, MD, PhD",{"facility":93,"status":43,"city":94,"state":23,"zip":95,"country":46,"countryCode":47,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Haugesunds Sanitetsforening Revmatismesykehus","Haugesund","5504",{"type":49,"coordinates":97},[98,99],5.268,59.41378,{"lat":99,"lon":98},[102],{"name":103,"role":34,"phone":23,"phoneExt":23,"email":23},"Mathias M Braaten, MD",{"facility":105,"status":43,"city":106,"state":23,"zip":23,"country":46,"countryCode":47,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Sørlandet Sykehus","Kristiansand",{"type":49,"coordinates":108},[109,110],7.9956,58.14671,{"lat":110,"lon":109},[113],{"name":114,"role":34,"phone":23,"phoneExt":23,"email":23},"Jintana B Andersen, MD PhD",{"facility":116,"status":43,"city":117,"state":23,"zip":23,"country":46,"countryCode":47,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Revmatismesykehuset AS","Lillehammer",{"type":49,"coordinates":119},[120,121],10.46628,61.11514,{"lat":121,"lon":120},[124],{"name":125,"role":34,"phone":23,"phoneExt":23,"email":126},"Yi Hu, MD, PhD","Yi.Hu@revmatismesykehuset.no",{"facility":128,"status":43,"city":129,"state":23,"zip":130,"country":46,"countryCode":47,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Helgelandssykehuset, Mo i Rana","Mo i Rana","8613",{"type":49,"coordinates":132},[133,134],14.14278,66.31278,{"lat":134,"lon":133},[137],{"name":138,"role":34,"phone":23,"phoneExt":23,"email":23},"Inger M Hansen, MD",{"facility":140,"status":43,"city":141,"state":23,"zip":142,"country":46,"countryCode":47,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Department of Rheumatology, Diakonhjemmet Hospital","Oslo","0319",{"type":49,"coordinates":144},[145,146],10.74609,59.91273,{"lat":146,"lon":145},[149],{"name":38,"role":34,"phone":150,"phoneExt":23,"email":39},"+22451500",{"facility":152,"status":43,"city":153,"state":23,"zip":154,"country":46,"countryCode":47,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Martina Hansens Hospital AS","Sandvika","1306",{"type":49,"coordinates":156},[157,158],13.59125,64.46377,{"lat":158,"lon":157},[161],{"name":162,"role":34,"phone":23,"phoneExt":23,"email":23},"Annicken Slagsvold, MD",{"facility":164,"status":43,"city":165,"state":23,"zip":23,"country":46,"countryCode":47,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"University Hospital of Northern Norway","Tromsø",{"type":49,"coordinates":167},[168,169],18.95508,69.6489,{"lat":169,"lon":168},[172],{"name":173,"role":34,"phone":23,"phoneExt":23,"email":23},"Gunnstein Bakland, MD, PhD",{"facility":175,"status":43,"city":176,"state":23,"zip":177,"country":46,"countryCode":47,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"Department of Rheumatology, St Olavs Hospital HF","Trondheim","7006",{"type":49,"coordinates":179},[180,181],10.39506,63.43049,{"lat":181,"lon":180},[184],{"name":185,"role":34,"phone":23,"phoneExt":23,"email":23},"Agnete Malm Gulati, MD, PhD",{"type":31,"investigatorFullName":187,"investigatorTitle":188,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Siri Lillegraven","Principal Investigator","100461681","imaging-treat-to-target-strategy-vs-conventional-treat-to-target-strategy-in-psoriatic-arthritis-100461681",false,"NCT05291819","Imaging Treat-to-target Strategy vs Conventional Treat-to-target Strategy in Psoriatic Arthritis","A NORwegian Randomized Strategy Trial in PsoRiatic Arthritis: ImagiNg Treat-to-target vs Conventional Treat-to-target","NOR-SPRINT","Inclusion Criteria:\n\n1. Adult (\\>18 years of age)\n2. Clinical diagnosis of PsA\n3. Indication for treatment with DMARDs according to treating physician (including having attempted ≥2 non-steroidal anti-inflammatory drugs (NSAIDs) for a minimum of 4 weeks in total in predominantly axial and\u002For entheseal disease)\n4. Fulfillment of CASPAR criteria for PsA\n\nExclusion Criteria:\n\n1. Verified arthritis \\>1 year prior to inclusion\n2. Previous DMARD treatment for PsA\n3. Systemic glucocorticoid use within the last 3 months\n4. Local glucocorticoid injections within the last 4 weeks\n5. Major co-morbidities, including but not limited to relevant malignancies, severe diabetes mellitus, severe infections, uncontrolled hypertension, severe cardiovascular disease (NYHA class III or IV) and\u002For severe respiratory diseases and cirrhosis.\n6. Indications of active or latent tuberculosis (TB) as assessed by chest radiograph and TB interferon gamma release assay (IGRA). Patients with documented adequately treated latent TB can be included.\n7. Any other medical condition that according to the treated physician and\u002For local guidelines makes adherence to treatment protocol impossible\n8. Abnormal renal function, defined as serum creatinine \\>142 µmol\u002FL in female and \\>168 µmol\u002FL in male, or estimated glomerular filtration rate (eGFR) \\\u003C40 mL\u002Fmin\u002F1.73 m2\n9. Abnormal liver function (defined as Aspartate Transaminase (AST) and\u002For Alanine Transaminase (ALT) \\>1.5 x upper normal limit), active or recent hepatitis\n10. Significant anemia, leukopenia and\u002For thrombocytopenia\n11. Inadequate birth control, pregnancy, and\u002For breastfeeding (current at screening or planned within the duration of the study)\n12. Contraindications to magnetic resonance imaging\n13. Severe psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible\n14. Established or suspected widespread-pain syndrome\u002Ffibromyalgia","ALL","18 Years",{"count":200,"type":201},202,"ESTIMATED","INTERVENTIONAL",[204],"NA","The main objective is to assess if a treat-to-target strategy implementing structured imaging assessments leads to better patient outcome in terms of sustained remission compared to a conventional treat-to-target strategy in psoriatic arthritis.\n\nMain inclusion criteria are: \\>18 years of age, Clinical diagnosis of psoriatic arthritis (PsA), Fulfillment of ClASsification of Psoriatic Arthritis (CASPAR) criteria, Indication for treatment with disease modifying anti-rheumatic drugs according to treating physician\n\nPrimary endpoint: Sustained remission, defined as Very Low Disease Activity (VLDA) at 16, 20 and 24 months\n\nSecondary endpoints: Individual and composite disease activity measures and remission criteria, inflammation assessed by ultrasound, health related quality of life and adverse events.\n\nStudy design: A two-arm, parallel-group, single-blind, treatment strategy study where patients are randomized 1:1 to a conventional treat-to-target follow-up strategy with structured clinical assessment of disease activity or an imaging informed treat-to-target follow-up strategy with both structured clinical assessment of disease activity and structured imaging assessment of disease activity. Duration of follow-up is 24 months.\n\nAll patients are treated according to an algorithm based on current European recommendations. The conventional treatment target, applicable to both arms and the sole target in the conventional arm, is all of: Disease Activity index in Psoriatic Arthritis (DAPSA) remission (≤3), Enthesitis ≤1, Psoriasis Body Surface Area ≤3%\n\nIntervention: A treat-to-target treatment strategy incorporating information from ultrasound assessment of joints, tendons and entheses (at every visit), and magnetic resonance imaging (MRI) of spine and sacroiliac (SI)-joints at baseline and 1 year, in addition to clinical information. Specifically, this means that these additional measures will be added to conventional treat to target:\n\n* If evidence of enthesitis or axial inflammation on imaging the patient will progress directly to biological disease modifying antirheumatic drug in the treatment algorithm\n* If evidence of ongoing inflammation (power Doppler\\>0) on ultrasound assessment of joints, tendons or enthesis, the patient will be classified as not having reached their treatment target",[207],"Psoriatic Arthritis",[209,210],"Imaging","Treat-to-target","2024-10-03",{"date":213,"type":214},"2024-10-04","ACTUAL",{"date":216,"type":214},"2022-03-14",{"date":218,"type":201},"2027-12-31",{"name":5,"class":6},12]