Preventing early joint damage in people with recent-onset psoriatic arthritis

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

This trial tests whether a TNF blocker (an adalimumab biosimilar) works better than injected methotrexate at preventing early joint damage in adults who recently developed psoriatic arthritis.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chinese University of Hong Kong (Academic / other)
• Drugs / interventions: adalimumab
• Locations: 1 site (Hong Kong)
• Trial ID: NCT07486843 on ClinicalTrials.gov

What this trial studies

This randomized, open-label Phase 4 trial assigns adults with recent-onset PsA to either subcutaneous methotrexate or an adalimumab biosimilar and follows them for 48 weeks. High-resolution peripheral quantitative CT (HR-pQCT) images of MCP joints 2–4 are taken at baseline, week 24, and week 48 to measure erosion and enthesiophyte progression. The primary outcome compares change in erosion volume across the MCP joints between the two treatment groups over 48 weeks. Participants are treatment-naïve to biologic or targeted synthetic DMARDs and must have active disease despite NSAIDs and at least one poor prognostic feature.

Who should consider this trial

Good fit: Adults (≥18) with symptom duration ≤2 years, active peripheral PsA despite NSAIDs, at least one poor prognostic factor, no prior b/tsDMARDs, and without severe MCP joint deformity.

Not a fit: People with long-standing PsA, prior biologic or targeted therapy, predominant axial disease requiring immediate biologic care, active infections, or who are pregnant are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the trial could show that early use of a TNF inhibitor better preserves joint structure than methotrexate, potentially reducing long-term damage and disability.

How similar studies have performed: Previous trials have shown that TNF inhibitors can reduce radiographic progression in PsA compared with placebo or conventional therapy, but direct head-to-head comparisons with methotrexate in early, treatment-naïve patients using HR-pQCT are limited.

Eligibility criteria

Inclusion Criteria:

* ≥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

Exclusion Criteria:

* on csDMARDs unless being prescribed for skin psoriasis (e.g. cyclosporin)
* limited in ability to perform usual self-care, vocational, and avocational activities
* pregnancy
* previous therapy with b/tsDMARDs
* predominant active axial PsA or significant uveitis/inflammatory bowel disease requiring immediate b/tsDMARDs therapy
* the presence of active inflammatory diseases other than PsA
* active infection in 2 weeks before randomization or a history of ongoing, chronic, or recurrent infections including tuberculosis
* 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)
* contraindications to MTX or adalimumab

Where this trial is running

Hong Kong

• The Chinese University of Hong Kong, Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)

Conditions Psoriatic Arthritis