Preventing Structural Damage in Early Psoriatic Arthritis

NCT07486843 | Recruiting Phase 4

• 1 other identifier: 2024.661
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriatic Arthritis (PsA)

Outcome Measures

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

  48 weeks

Secondary Outcomes (4)

• 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

Study Arms (2)

MTX

ACTIVE COMPARATOR

Drug: Methotrexate (Metoject® prefilled pen)

Adalimumab biosimilar

ACTIVE COMPARATOR

Drug: Amgevita 40Mg Solution for Injection

Interventions

Amgevita 40Mg Solution for Injection DRUG

Amgevita 40mg

Adalimumab biosimilar

Methotrexate (Metoject® prefilled pen) DRUG

Metoject® PEN 7.5 mg, Metoject® PEN 10 mg, Metoject® PEN 15 mg, Metoject® PEN 20 mg, Metoject® PEN 25 mg

MTX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong, Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Solutions; Injections; Methotrexate

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: March 23, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-01

Locations

HK (1)