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

Not Applicable

Withdrawn

• Conditions: Psoriasis

• 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• Status: WITHDRAWN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

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