FibroScan ® Study: Assessing Liver Fibrosis in Patients Using Methotrexate for Psoriasis

Psoriasis Clinical Trial

Official title:

A Prospective, Validation Study of FibroSURE™ and FibroScan® as Screening, Detection, and Monitoring Alternatives to Liver Biopsy for Methotrexate-induced Hepatic Fibrosis and Cirrhosis in Patients With Psoriasis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03820934
• Other study ID #: 12-17-09
• Status: Withdrawn
• Phase: N/A
• Start date: February 10, 2019
• Est. completion date: May 15, 2019

Study information

• Verified date: July 2020
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to validate FibroScan and FibroSURE™ as equal or superior alternatives to liver biopsy for the monitoring and detection of methotrexate-induced hepatic fibrosis and cirrhosis in patients with moderate-to-severe psoriasis.

Description:

The goals of this study are to validate FibroScan and FibroSURE™ as equal or superior alternatives to liver biopsy. The goal is to evaluate the monitoring and detection of methotrexate-induced hepatic fibrosis and cirrhosis in patients with moderate-to-severe psoriasis.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 15, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female greater than or equal to 18 years of age

• Must have a diagnosis of moderate-to-severe psoriasis

• Newly starting methotrexate

Exclusion Criteria:

• Allergy to methotrexate

• History of chronic alcohol abuse

• Diagnosis of liver disease

Related Conditions & MeSH terms

• Fibrosis
• Psoriasis

Intervention

Diagnostic Test:
• Fibroscan and Fibrosure
Patient's will undergo fibroscan and fibrosure to test their liver for the level of liver fibrosis as measured by these tests. Fibroscan uses vibrations sent through the liver to measure its stiffness and the fibrosure uses laboratory and demographic parameters to create a score associated with a certain level of fibrosis. The scores from these tests will then be compared to the amount of fibrosis noted on a standard of care liver biopsy.

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibrosis Score Correlation	The correlation between the clinical fibrosis scores generated by the FibroScan® and FibroSURE™ alone and in combination to the METAVIR fibrosis score generated from the histologic review of a liver biopsy performed for the assessment of liver fibrosis in a psoriasis patient who reaches a cumulative methotrexate dose of 1g.	5 years
Secondary	Fibrosis Score Validity to Liver Biopsy Results	Determine if the clinical fibrosis scores generated by the FibroScan® and FibroSURE™ alone and in combination can be safely used as alternatives to performing a liver biopsy when screening for liver fibrosis in psoriasis patients who have reached a cumulative methotrexate dose of 1 gram	5 years