NCT07486843RecruitingPhase 4
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)
Source: ClinicalTrials.gov · Last updated 23 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 108 (estimated)
- First submitted
- 23 Jan 2026
- Start date
- 16 Mar 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Psoriasis, Psoriatic arthritis
- NCT number
- NCT07486843
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 108
- From 16 Mar 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous therapy with b/tsDMARDs
- active infection in 2 weeks before randomization or a history of ongoing, chronic, or recurrent infections including tuberculosis
Other illness
- predominant active axial PsA or significant uveitis/inflammatory bowel disease requiring immediate b/tsDMARDs therapy
- the presence of active inflammatory diseases other than PsA
- 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)
Other
- on csDMARDs unless being prescribed for skin psoriasis (e.g. cyclosporin)
- limited in ability to perform usual self-care, vocational, and avocational activities
- pregnancy
- contraindications to MTX or adalimumab
Who the study is looking for
- ≥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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Chinese University of Hong Kong, Prince of Wales Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.