beta
Trial Radar AI
Clinical Trial NCT07486843 for Psoriatic Arthritis (PsA) is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

Preventing Structural Damage in Early Psoriatic Arthritis Phase 4 108 Randomized

Recruiting
Clinical Trial NCT07486843 is designed to study Treatment for Psoriatic Arthritis (PsA). It is a Phase 4 interventional study that is recruiting, having started on March 16, 2026, with plans to enroll 108 participants. Led by Chinese University of Hong Kong, it is expected to complete by December 31, 2028. The latest data from ClinicalTrials.gov was last updated on March 23, 2026.
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 wi...
Show More
Official Title

Methotrexate Versus TNF Inhibition in Preventing Structural Damage in Early Psoriatic Arthritis: A Randomized Trial Using HR-pQCT (MeTEPsA Trial)

Conditions
Psoriatic Arthritis (PsA)
Other Study IDs
  • 2024.661
NCT ID Number
NCT07486843
Start Date (Actual)
2026-03-16
Last Update Posted
2026-03-23
Completion Date (Estimated)
2028-12-31
Enrollment (Estimated)
108
Study Type
Interventional
PHASE
Phase 4
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorMTX
Methotrexate (Metoject® prefilled pen)
Metoject® PEN 7.5 mg, Metoject® PEN 10 mg, Metoject® PEN 15 mg, Metoject® PEN 20 mg, Metoject® PEN 25 mg
Active ComparatorAdalimumab biosimilar
Amgevita 40Mg Solution for Injection
Amgevita 40mg
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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 Outcome Measures
Outcome MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • ≥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

  • 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
Chinese University of Hong Kong logoChinese University of Hong Kong474 active studies to explore
Study Responsible Party
Lai-Shan Tam, Principal Investigator, Professor, Chinese University of Hong Kong
No contact data.
1 Study Locations in 1 Countries
The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong, Hong Kong
Prof. Tam, Contact, 852-35051429, [email protected]
Recruiting