[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630374":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":11,"locations":28,"responsibleParty":46,"collaborators":11,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":11,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":11,"enrollmentInfo":59,"targetDuration":11,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":11,"overallStatus":31,"whyStopped":11,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MTX","ACTIVE_COMPARATOR",null,[13],"Drug: Methotrexate (Metoject® prefilled pen)",{"label":15,"type":10,"description":11,"interventionNames":16},"Adalimumab biosimilar",[17],"Drug: Amgevita 40Mg Solution for Injection",[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","Amgevita 40Mg Solution for Injection","Amgevita 40mg",[15],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Methotrexate (Metoject® prefilled pen)","Metoject® PEN 7.5 mg, Metoject® PEN 10 mg, Metoject® PEN 15 mg, Metoject® PEN 20 mg, Metoject® PEN 25 mg",[9],[29],{"facility":30,"status":31,"city":32,"state":11,"zip":11,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"The Chinese University of Hong Kong, Prince of Wales Hospital","RECRUITING","Hong Kong","HK",{"type":35,"coordinates":36},"Point",[37,38],114.17469,22.27832,{"lat":38,"lon":37},[41],{"name":42,"role":43,"phone":44,"phoneExt":11,"email":45},"Prof. Tam","CONTACT","852-35051429","lstam@cuhk.edu.hk",{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Lai-Shan Tam","Professor","100630374","phase-4-preventing-structural-damage-in-early-psoriatic-arthritis-100630374",false,"NCT07486843","Preventing Structural Damage in Early Psoriatic Arthritis","Methotrexate Versus TNF Inhibition in Preventing Structural Damage in Early Psoriatic Arthritis: A Randomized Trial Using HR-pQCT (MeTEPsA Trial)","Inclusion Criteria:\n\n* ≥18 years old\n* without severe deformity in MCPJ\n* with active disease, which is defined as ≥1 tender joints and ≥1 swollen joints, despite previous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for ≥ 4 weeks\n* with at least one poor prognostic factor (eg, polyarthritis, structural damage on HR-pQCT or CR, elevated acute phase reactants, dactylitis, nail involvement or HAQ-DI\\>1)\n* symptom duration ≤ 2 years\n\nExclusion Criteria:\n\n* on csDMARDs unless being prescribed for skin psoriasis (e.g. cyclosporin)\n* limited in ability to perform usual self-care, vocational, and avocational activities\n* pregnancy\n* previous therapy with b\u002FtsDMARDs\n* predominant active axial PsA or significant uveitis\u002Finflammatory bowel disease requiring immediate b\u002FtsDMARDs therapy\n* the presence of active inflammatory diseases other than PsA\n* active infection in 2 weeks before randomization or a history of ongoing, chronic, or recurrent infections including tuberculosis\n* history of malignant disease within the past 5 years (excluding basal cell carcinoma or actinic keratosis, in-situ cervical cancer, or non-invasive malignant colon polyps)\n* contraindications to MTX or adalimumab","ALL","18 Years",{"count":60,"type":61},108,"ESTIMATED","INTERVENTIONAL",[64],"PHASE4","Investigators hypothesize that TNFi is superior to SC MTX in preventing structural damage in early, treatment-naïve PsA, assessed using HR-pQCT. The study aims to ascertain:\n\n\\- The effect of SC MTX and TNFi (adalimumab biosimilar) on erosion and enthesiophyte progression in early PsA by HR-pQCT.\n\nParticipants will be:\n\n* Randomized in a 1:1 ratio to either the SC MTX group or the TNFi group.\n* HR-pQCT of MCPJ 2-4 will be performed at baseline, week 24, and one year.\n\nThe primary outcome is the comparison of change in erosion volume over MCPJ 2-4 across 48 weeks between the SC MTX group (group 1) and the TNFi group (group 2), assessed by HR-pQCT.",[67],"Psoriatic Arthritis (PsA)","2026-03-18",{"date":70,"type":71},"2026-03-23","ACTUAL",{"date":73,"type":71},"2026-03-16",{"date":75,"type":61},"2028-12-31",{"name":5,"class":6},1]