Prospective Evaluation of FibroScan in Patients Treated With Methotrexate

Liver Fibrosis Clinical Trial

— Methoscan  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00673101
• Other study ID #: 05-07
• Status: Completed
• Start date: January 2006
• Est. completion date: July 2019

Study information

• Verified date: July 2019
• Source: Association HGE CHU Bordeaux Sud
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1871
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Liver Fibrosis

Locations

Country	Name	City	State
France	Hopital du Haut Leveque	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
Association HGE CHU Bordeaux Sud

Country where clinical trial is conducted

France,