Clinical trial NCT00673101: Prospective Evaluation of FibroScan in Patients Treated With Methotrexate
Official title: Evaluation of Liver Fibrosis Using FibroScan and Non-invasive Biochemical Markers in Patients Treated With Methotrexate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Fibrosis
Keywords: liver fibrosis, cirrhosis
FibroScan
transient elastography
elastometry
methotrexate
non invasive blood markers
FibroTest
treatment
Lead sponsor: Association HGE CHU Bordeaux Sud
Sponsor class: OTHER
First posted: 2008-05-07
Enrollment: 1871
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated by Methotrexate

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pessac
country: France
facility: Hopital du Haut Leveque
Study officials:
affiliation: University Hospital, Bordeaux
name: Thierry Schaeverbeke, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gastroenterology and Hepatology Unit, Haut-Lévêque Hospital, 33604 Pessac, France
name: Edouard Chabrun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Thomas Hubiche, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Marie-Sylvie Doutre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Bodeaux
name: Maïté Longy-Boursier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Jean-Luc Pellegrin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gastroenterology and Hepatology Unit, Haut-Lévêque Hospital, 33604 Pessac, France
name: Juliette Foucher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gastroenterology and Hepatology Unit, Saint-André Hospital, 33075 Bordeaux, Cedex, France
name: Franck Zerbib, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: David Laharie, MD PhD
role: STUDY_DIRECTOR
References: