Preventing Structural Damage in Early Psoriatic Arthritis
Recruiting · NCT07486843 · Interventional (participants receive a specific treatment) · Lead sponsor: Chinese University of Hong Kong
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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 is running
1 location listed.
- The Chinese University of Hong Kong, Prince of Wales Hospital - Hong Kong, Hong Kong