Psoriatic Arthritis (PsA)
Conditions
Brief summary
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.
Interventions
Amgevita 40mg
Metoject® PEN 7.5 mg, Metoject® PEN 10 mg, Metoject® PEN 15 mg, Metoject® PEN 20 mg, Metoject® PEN 25 mg
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in erosion volume (mm³) in the MCPJ 2-4 over a period of 48 weeks between Group 1 (MTX) and Group 2 (TNFi group) assessed by HR-pQCT | 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The change in erosion volume (mm³) in the MCPJ 2-4 over a period of 24 weeks | 24 weeks |
| The proportion (in percentage) of erosions showing partial healing at weeks 24 and 48 | Week 24 and 48 |
| The change in the enthesiophyte volume (mm³) at weeks 24 and 48 | Weeks 24 and 48 |
| The proportion (in percentage) of enthesiophytes exhibiting progression at weeks 24 and 48 | Week 24 and 48 |
Countries
Hong Kong
Outcome results
None listed