Psoriasis
Conditions
Keywords
Methotrexate, FibroScan, FibroSure, Cirrhosis, Fibrosis
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.
Interventions
DIAGNOSTIC_TESTFibroscan 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.
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed