Methotrexate Polyglutamates as a Marker of Clinical Response and Toxicity in the Treatment of Psoriasis
试验速览
- 阶段
- 不适用
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Serial erythrocyte methotrexate polyglutamate measurements using high performance liquid chromotography
研究概览
简要总结
Methotrexate (MTX) is widely prescribed to treat inflammatory conditions including psoriasis, where it is the recommended first-line systemic therapy in moderate-to-severe disease. Approximately 40% of patients with psoriasis have a sub-optimal response to MTX and a significant number experience side effects that may include deranged liver enzymes. There is currently no validated test to predict how patients with psoriasis will respond to MTX, in terms of disease outcome and/or toxicity, or to guide dose escalation in this group.
详细描述
Data for this study is drawn from the BSTOP (Biomarkers of Systemic Treatment Outcomes in Psoriasis) cohort. This is a multi-centre, prospective, cohort study to establish clinically relevant biomarkers and pharmacogenetic markers of systemic treatment outcomes in patients with severe psoriasis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
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
- •Patients with psoriasis
- •Taking oral or subcutaneous methotrexate
- •Measurement of methotrexate polyglutamates on at least one occasion during therapy.
- •Patients who have given written informed consent
排除标准
- •Unable to consent
- •Not taking methotrexate
结局指标
主要结局
Serial erythrocyte methotrexate polyglutamate measurements using high performance liquid chromotography
时间窗: From 3 months to 5 years after commencing methotrexate
To determine if there is a correlation between methotrexate polyglutamate concentrations and clinical response measured by Psoriasis Area Severity Index( PASI) in patients on methotrexate monotherapy with psoriasis. This will consider potential confounding factors, including age, gender and dose of MTX
次要结局
- Alanine transaminase (ALT) and Full blood count (FBC) will be used to measure toxicity to methotrexate(3 months to 5 years after first MTX dose)