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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03820934
Other study ID # 12-17-09
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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