Prospective Evaluation of FibroScan in Patients Treated With Methotrexate (Methoscan)
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Purpose
The aim of this study is to evaluate liver fibrosis using FibroScan and biochemical markers in patients treated with methotrexate.
| Condition |
|---|
|
Liver Fibrosis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Evaluation of Liver Fibrosis Using FibroScan and Non-invasive Biochemical Markers in Patients Treated With Methotrexate |
| Estimated Enrollment: | 500 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients treated by Methotrexate
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
Contacts and Locations| France | |
| Hopital du Haut Leveque | Recruiting |
| Pessac, France, 33600 | |
| Contact: David Laharie, MD, PhD 33-557-656-439 david.laharie@chu-bordeaux.fr | |
| Contact: Sandrine Villars, PhD 33-557-656-311 sandrine.villars@chu-bordeaux.fr | |
| 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 |
More Information
No publications provided
| Responsible Party: | Pr Victor De Lédinghen, MD PhD, CHU de Bordeaux |
| ClinicalTrials.gov Identifier: | NCT00673101 History of Changes |
| Other Study ID Numbers: | 05-07 |
| Study First Received: | May 6, 2008 |
| Last Updated: | June 20, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Association HGE CHU Bordeaux Sud:
|
liver fibrosis, cirrhosis FibroScan transient elastography elastometry |
methotrexate non invasive blood markers FibroTest treatment |
Additional relevant MeSH terms:
|
Fibrosis Liver Cirrhosis Pathologic Processes Liver Diseases Digestive System Diseases Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013