Preventing Structural Damage in Early Psoriatic Arthritis
ConditionPsoriatic Arthritis (PsA)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this trial
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
Qualifiers
≥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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Amgevita 40Mg Solution for Injection
- Methotrexate (Metoject® prefilled pen)
Treatment groups
108 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov