NCT07486843 Preventing Structural Damage in Early Psoriatic Arthritis
| NCT ID | NCT07486843 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Chinese University of Hong Kong |
| Condition | Psoriatic Arthritis (PsA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2026-03-16 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 108 participants in total. It began in 2026-03-16 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT07486843 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Psoriatic Arthritis (PsA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07486843 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07486843 currently recruiting?
Yes, NCT07486843 is actively recruiting participants. Visit ClinicalTrials.gov or contact Chinese University of Hong Kong to inquire about joining.
Where is the NCT07486843 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT07486843 clinical trial?
NCT07486843 is sponsored by Chinese University of Hong Kong. The trial plans to enroll 108 participants.