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

Not Applicable

Withdrawn

• Conditions: Psoriasis
• Interventions: Diagnostic Test: Fibroscan and Fibrosure

• Registration Number: NCT03820934
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-01-15
• Study First Submitted QC: 2019-01-28
• Study First Posted: 2019-01-29
• Study Start: 2019-02-10
• Primary Completion: 2019-05-15
• Study Completion: 2019-05-15
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients undergoing Fibroscan and Fibrosure	Fibroscan and Fibrosure	Patient's will undergo fibroscan and fibrosure to test their liver for the level of liver fibrosis as measured by these test. The scores from these tests will then be compared to the amount of fibrosis noted on a standard of care liver biopsy.

Primary Outcome Measures

Name	Time	Method
Fibrosis Score Correlation	5 years	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.

Secondary Outcome Measures

Name	Time	Method
Fibrosis Score Validity to Liver Biopsy Results	5 years	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

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States