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临床试验/NCT00673101
NCT00673101已完成不适用

Evaluation of Liver Fibrosis Using FibroScan and Non-invasive Biochemical Markers in Patients Treated With Methotrexate

Association HGE CHU Bordeaux Sud1 个研究点 分布在 1 个国家目标入组 1,871 人开始时间: 2006年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,871
试验地点
1

研究概览

简要总结

The aim of this study is to evaluate liver fibrosis using FibroScan and biochemical markers in patients treated with methotrexate.

详细描述

Methotrexate (MTX) is an effective treatment for induction of remission and maintenance in patients with Crohn's disease, rheumatoid arthritis, or psoriasis which may induce liver fibrosis with high cumulative doses. Transient elastography (FibroScan) is a new non-invasive rapid, reproducible and bed-side method, allowing assessment of liver fibrosis by measurement of liver stiffness. A preliminary study (Laharie et al, Alimentary Pharmaceutical Therapeutics 2006) had shown that significant liver fibrosis was rare in Crohn's disease patients treated with a high dose of methotrexate. FibroScan was a reliable non-invasive method to detect liver fibrosis which could be recommended in these patients. Therefore, liver biopsy could be performed only with patients with high FibroScan values and/or with chronic liver enzymes abnormalities. However, further longitudinal and prospective studies are mandatory to confirm these preliminary data, in patients with crohn's disease but also with rheumatoid arthritis and psoriasis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female subjects, ≥18 years of age.
  • Patient treated with Methotrexate.
  • Written informed consent

排除标准

  • Patients refusing to participate to the study and to provide written informed consent
  • Pregnant women

研究者

发起方
Association HGE CHU Bordeaux Sud
申办方类型
Other
责任方
Principal Investigator
主要研究者

de Ledinghen

Professor

Association HGE CHU Bordeaux Sud

研究点 (1)

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