Preventing Structural Damage in Early Psoriatic Arthritis

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Amgevita 40Mg Solution for Injection
  Amgevita 40mg
• Препарат 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

Первичные конечные точки

• 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 [Срок оценки: 48 weeks]

Вторичные конечные точки (4)

• The change in erosion volume (mm³) in the MCPJ 2-4 over a period of 24 weeks [Срок оценки: 24 weeks]
• The proportion (in percentage) of erosions showing partial healing at weeks 24 and 48 [Срок оценки: Week 24 and 48]
• The change in the enthesiophyte volume (mm³) at weeks 24 and 48 [Срок оценки: Weeks 24 and 48]
• The proportion (in percentage) of enthesiophytes exhibiting progression at weeks 24 and 48 [Срок оценки: Week 24 and 48]

Критерии участия

Критерии включения

• ≥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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• The Chinese University of Hong Kong, Prince of Wales Hospital — Гонконг

Идентификаторы

NCT: NCT07486843 · 2024.661

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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