NCT00673101

Prospective Evaluation of FibroScan in Patients Treated With Methotrexate

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,871 (actual)
• Sponsor: Association HGE CHU Bordeaux Sud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Liver Fibrosis

Timeline

• Start date: 2006-01-01
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2008-05-07
• Last updated: 2019-07-05

Locations

1 site across 1 country: France