Actively Recruiting
Preventing Structural Damage in Early Psoriatic Arthritis
Led by Chinese University of Hong Kong · Updated on 2026-03-23
108
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Preventing Structural Damage in Early Psoriatic Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- No severe deformity in metacarpophalangeal joints (MCPJ)
- Active disease defined as at least 1 tender joint and 1 swollen joint despite treatment with NSAIDs for at least 4 weeks
- At least one poor prognostic factor such as polyarthritis, structural damage on HR-pQCT or conventional radiography, elevated acute phase reactants, dactylitis, nail involvement, or HAQ-DI greater than 1
- Symptom duration of 2 years or less
You will not qualify if you...
- Receiving conventional synthetic DMARDs unless prescribed for skin psoriasis (e.g., cyclosporin)
- Limited ability to perform usual self-care, work, or recreational activities
- Pregnancy
- Previous therapy with biological or targeted synthetic DMARDs
- Predominant active axial psoriatic arthritis or significant uveitis/inflammatory bowel disease requiring immediate biological or targeted synthetic DMARD therapy
- Presence of active inflammatory diseases other than psoriatic arthritis
- Active infection within 2 weeks before randomization or history of ongoing, chronic, or recurrent infections including tuberculosis
- History of malignant disease within the past 5 years (excluding basal cell carcinoma, actinic keratosis, in-situ cervical cancer, or non-invasive malignant colon polyps)
- Contraindications to methotrexate or adalimumab
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Chinese University of Hong Kong, Prince of Wales Hospital
Hong Kong, Hong Kong
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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