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
This trial does not accept healthy volunteersQualifiers
≥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
Design model
Parallel
Treatments tested in this trial
Amgevita 40Mg Solution for Injection
DrugAmgevita 40mg
Methotrexate (Metoject® prefilled pen)
DrugMetoject® PEN 7.5 mg, Metoject® PEN 10 mg, Metoject® PEN 15 mg, Metoject® PEN 20 mg, Metoject® PEN 25 mg
Treatment groups
108 Participants
are divided into 2 treatment groupsGroup A: MTXActive comparator 1 intervention
Group B: Adalimumab biosimilarActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
48 weeksSecondary outcomes
1
The change in erosion volume (mm³) in the MCPJ 2-4 over a period of 24 weeks
Time frame
24 weeks2
The proportion (in percentage) of erosions showing partial healing at weeks 24 and 48
Time frame
Week 24 and 483
The change in the enthesiophyte volume (mm³) at weeks 24 and 48
Time frame
Weeks 24 and 484
The proportion (in percentage) of enthesiophytes exhibiting progression at weeks 24 and 48
Time frame
Week 24 and 48Sponsors and contacts
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Source ClinicalTrials.gov