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

University Hospitals (UH)

Status: Withdrawn

Conditions: Psoriasis

Treatments: Diagnostic Test: Fibroscan and Fibrosure

Study type: Interventional

Funder types: Other

Identifiers

NCT03820934

12-17-09

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Patients undergoing Fibroscan and Fibrosure

Other group

Description:

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.

Treatment:

Diagnostic Test: Fibroscan and Fibrosure