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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Association HGE CHU Bordeaux Sud.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Association HGE CHU Bordeaux Sud
ClinicalTrials.gov Identifier:
NCT00673101
First received: May 6, 2008
Last updated: June 20, 2012
Last verified: June 2012
  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

Resource links provided by NLM:


Further study details as provided by Association HGE CHU Bordeaux Sud:

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)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients treated by Methotrexate

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673101

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   
Sponsors and Collaborators
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
  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 September 15, 2014