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)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psoriatic Arthritis (PsA)

Interventions

Type	Name	Description
DRUG	Amgevita 40Mg Solution for Injection	Amgevita 40mg
DRUG	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

Timeline

• Start date: 2026-03-16
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2026-03-23
• Last updated: 2026-03-23

Locations

1 site across 1 country: Hong Kong