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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.