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Taking people in Hong KongPhase 4

Comparing Two Treatments for Preventing Joint Damage in Early Psoriatic Arthritis

Compares methotrexate with a TNF inhibitor in adults with newly diagnosed psoriatic arthritis.

Key facts

Who runs it
Chinese University of Hong Kong
Where
Hong Kong, Hong KongSee the site
Trial code
Registry title
Preventing Structural Damage in Early Psoriatic Arthritis
Status
Recruiting
Phase
Phase 4
People taking part
108 people, planned
Started
16 Mar 2026
Expected to end
31 Dec 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Amgevita 40Mg Solution for Injection
  • Methotrexate (Metoject® prefilled pen)
Record updated
23 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with early psoriatic arthritis who have not been treated with disease-modifying drugs. It compares methotrexate with a TNF inhibitor (adalimumab biosimilar).

Age
18 years or older
Sex
All sexes can join.
Disease stage
Early psoriatic arthritis with symptoms for 2 years or less, active disease (at least 1 tender joint and at least 1 swollen joint despite NSAIDs for at least 4 weeks), no severe deformity in the finger knuckle joints (MCPJ), and at least one poor prognostic factor (for example many joints involved, joint damage on imaging, high inflammation blood tests, dactylitis, nail involvement or HAQ-DI above 1).
Earlier treatment
Must have tried nonsteroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks. Cannot have had csDMARDs (except for skin psoriasis, for example cyclosporin) or b/tsDMARDs before.

Main reasons for not taking part

  • Pregnancy
  • Mainly axial (spine) psoriatic arthritis, or significant uveitis or inflammatory bowel disease needing b/tsDMARDs right away
  • Active infection in the 2 weeks before randomization, or ongoing, chronic or recurrent infections including tuberculosis
  • Cancer in the past 5 years (some skin, cervical and colon polyp types excepted)
  • Contraindications to methotrexate or adalimumab

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • ≥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

Who cannot take part

  • previous therapy with b/tsDMARDs
  • active infection in 2 weeks before randomization or a history of ongoing, chronic, or recurrent infections including tuberculosis
  • 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)
  • 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

Where in Hong Kong

  • The Chinese University of Hong Kong, Prince of Wales HospitalHong Kong, Hong KongContact: Prof. TamTaking people

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

- 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.

The 2 groups in the trial

  • MTXExisting treatment, for comparison

    Treatment: Methotrexate (Metoject® prefilled pen)

  • Adalimumab biosimilarExisting treatment, for comparison

    Treatment: Amgevita 40Mg Solution for Injection

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Methotrexate Versus TNF Inhibition in Preventing Structural Damage in Early Psoriatic Arthritis: A Randomized Trial Using HR-pQCT (MeTEPsA Trial)
Plain-language title
Comparing Two Treatments for Preventing Joint Damage in Early Psoriatic ArthritisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
23 March 2026