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Prospective Evaluation of FibroScan in Patients Treated With Methotrexate (Methoscan)

A

Association HGE CHU Bordeaux Sud

Status

Completed

Conditions

Liver Fibrosis

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

1,871 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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