Phase 4: testing Amgevita 40Mg Solution for Injection for Psoriatic Arthritis (PsA)
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.
Official registry: https://clinicaltrials.gov/study/NCT07486843 · Chinese University of Hong Kong · enrollment listed as 108
What this phase means
Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Amgevita 40Mg Solution for Injection, or Methotrexate (Metoject® prefilled pen). The registry lists allocation as randomized. Investigators hypothesize that TNFi is superior to SC MTX in preventing structural damage in early, treatment-naïve PsA, assessed using HR-pQCT.
They plan to enroll about 108 people at Hong Kong. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Methotrexate Versus TNF Inhibition in Preventing Structural Damage in Early Psoriatic Arthritis: A Randomized Trial Using HR-pQCT (MeTEPsA Trial)
Interventions: Amgevita 40Mg Solution for Injection, Methotrexate (Metoject® prefilled pen)
Primary outcome (registry wording): 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
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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
Who the registry excludes
- on csDMARDs unless being prescribed for skin psoriasis (e.g. cyclosporin)
- limited in ability to perform usual self-care, vocational, and avocational activities
- 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)
Contact
No central phone on the registry card. Use the official listing to reach a site.
Sites listed on ClinicalTrials.gov
1 listed- The Chinese University of Hong Kong, Prince of Wales Hospital — Hong Kong, Hong Kong (recruiting)
FAQ about this NCT record
Is NCT07486843 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07486843?
Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07486843?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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