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

NCT03820934 | Withdrawn FDA Device

• 1 other identifier: 12-17-09
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Methotrexate; FibroScan; FibroSure; Cirrhosis; Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Fibrosis Score Validity to Liver Biopsy Results

  5 years

Study Arms (1)

Patients undergoing Fibroscan and Fibrosure

OTHER

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.

Diagnostic Test: Fibroscan and Fibrosure

Interventions

Fibroscan and Fibrosure DIAGNOSTIC_TEST

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.

Patients undergoing Fibroscan and Fibrosure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female greater than or equal to 18 years of age
• Must have a diagnosis of moderate-to-severe psoriasis
• Newly starting methotrexate

You may not qualify if:

• Allergy to methotrexate
• History of chronic alcohol abuse
• Diagnosis of liver disease

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Psoriasis; Fibrosis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Neil Korman, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Trials Unit

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 29, 2019
• Study Start: February 10, 2019
• Primary Completion: May 15, 2019
• Study Completion: May 15, 2019
• Last Updated: July 23, 2020

Record last verified: 2020-07

Locations

US (1)