Prospective Evaluation of FibroScan in Patients Treated With Methotrexate

Completed

• Conditions: Liver Fibrosis

• Registration Number: NCT00673101
• Lead Sponsor: Association HGE CHU Bordeaux Sud

Brief 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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2008-05-06
• Study First Submitted QC: 2008-05-06
• Study First Posted: 2008-05-07
• Status Verified: 2019-07
• Primary Completion: 2019-07
• Study Completion: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1871

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Hopital du Haut Leveque; 🇫🇷 Pessac, France