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Methotrexate Versus TNF Inhibition in Preventing Structural Damage in Early Psoriatic Arthritis: A Randomized Trial Using HR-pQCT (MeTEPsA Trial)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥18 years old

• without severe deformity in MCPJ

• 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

• 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)

• symptom duration ≤ 2 years

Locations
Other Locations
Hong Kong Special Administrative Region
The Chinese University of Hong Kong, Prince of Wales Hospital
RECRUITING
Hong Kong
Time Frame
Start Date: 2026-03-16
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 108
Treatments
Active_comparator: MTX
Active_comparator: Adalimumab biosimilar
Related Therapeutic Areas
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov