RECRUITINGPhase 4INTERVENTIONAL

Preventing Structural Damage in Early Psoriatic Arthritis

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

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.

Who May Be Eligible (Plain English)

Who May Qualify: - ≥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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * ≥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 Exclusion Criteria: * 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

Treatments Being Tested

DRUG

Amgevita 40Mg Solution for Injection

Amgevita 40mg

DRUG

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

Locations (1)

The Chinese University of Hong Kong, Prince of Wales Hospital

Hong Kong, Hong Kong