NCT07486843招募中4 期
Methotrexate Versus TNF Inhibition in Preventing Structural Damage in Early Psoriatic Arthritis: A Randomized Trial Using HR-pQCT (MeTEPsA Trial)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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
排除标准
- •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
结局指标
主要结局
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
时间窗: 48 weeks
次要结局
- 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)
研究者
Lai-Shan Tam
Professor
Chinese University of Hong Kong
研究点 (1)
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