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

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

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

Study Overview

• Status: Completed
• Conditions: Liver Fibrosis

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 Type: Observational
• Enrollment (Actual): 1871

Contacts and Locations

Study Locations

• France
  • Pessac, France, 33600
    • Hôpital du Haut Lévêque

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients treated by Methotrexate

Description

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 Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Association HGE CHU Bordeaux Sud
• Investigators: Principal Investigator: Thierry Schaeverbeke, MD, PhD, University Hospital, Bordeaux; Principal Investigator: Edouard Chabrun, MD, Gastroenterology and Hepatology Unit, Haut-Lévêque Hospital, 33604 Pessac, France; Principal Investigator: Thomas Hubiche, MD, University Hospital, Bordeaux; Principal Investigator: Marie-Sylvie Doutre, MD, PhD, University Hospital, Bordeaux; Principal Investigator: Maïté Longy-Boursier, MD, PhD, CHU de Bodeaux; Principal Investigator: Jean-Luc Pellegrin, MD, PhD, University Hospital, Bordeaux; Principal Investigator: Juliette Foucher, MD, Gastroenterology and Hepatology Unit, Haut-Lévêque Hospital, 33604 Pessac, France; Principal Investigator: Franck Zerbib, MD PhD, Gastroenterology and Hepatology Unit, Saint-André Hospital, 33075 Bordeaux, Cedex, France; Study Director: David Laharie, MD PhD, CHU Bordeaux

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: May 6, 2008
• First Submitted That Met QC Criteria: May 6, 2008
• First Posted (Estimate): May 7, 2008

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: treatment; methotrexate; transient elastography; elastometry; FibroScan; FibroTest; liver fibrosis, cirrhosis; non invasive blood markers
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: 05-07