drugset / Trial / NCT07486843

Preventing Structural Damage in Early Psoriatic Arthritis

NCT07486843

Phase 4 Recruiting 108 enrolled Chinese University of Hong Kong
RandomizedParallel-groupOpen-labelTreatment

Summary

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: \- The effect of SC MTX and TNFi (adalimumab biosimilar) on erosion and enthesiophyte progression in early PsA by HR-pQCT. Participants will be: * Randomized in a 1:1 ratio to either the SC MTX group or the TNFi group. * HR-pQCT of MCPJ 2-4 will be performed at baseline, week 24, and one year. The 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.

Timeline

Start
2026-03-16
Primary completion
2027-12-31
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Adalimumab Monoclonal antibody 40 mg
Comparator Methotrexate Small molecule 7.5 mg Subcutaneous
Comparator Methotrexate Small molecule 10 mg Subcutaneous
Comparator Methotrexate Small molecule 15 mg Subcutaneous
Comparator Methotrexate Small molecule 20 mg Subcutaneous
Comparator Methotrexate Small molecule 25 mg Subcutaneous

Indications