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Preventing Structural Damage in Early Psoriatic Arthritis

RecruitingPhase 4Ages 18 Years - anyAllChinese University of Hong Kong
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Amgevita 40Mg Solution for Injection
  • Methotrexate (Metoject® prefilled pen)
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Where

1 site
The Chinese University of Hong Kong, Prince of Wales Hospital
Hong Kong, Hong Kong
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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