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

Primary Purpose

Psoriasis

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fibroscan and Fibrosure
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Psoriasis focused on measuring Methotrexate, FibroScan, FibroSure, Cirrhosis, Fibrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospitals Cleveland Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients undergoing Fibroscan and Fibrosure

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 15, 2019
Last Updated
July 22, 2020
Sponsor
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03820934
Brief Title
FibroScan ® Study: Assessing Liver Fibrosis in Patients Using Methotrexate for Psoriasis
Official Title
A Prospective, Validation Study of FibroSURE™ and FibroScan® as Screening, Detection, and Monitoring Alternatives to Liver Biopsy for Methotrexate-induced Hepatic Fibrosis and Cirrhosis in Patients With Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Per Investigator study was terminated prematurely
Study Start Date
February 10, 2019 (Actual)
Primary Completion Date
May 15, 2019 (Actual)
Study Completion Date
May 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Methotrexate, FibroScan, FibroSure, Cirrhosis, Fibrosis

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients undergoing Fibroscan and Fibrosure
Arm Type
Other
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Fibroscan and Fibrosure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fibrosis Score Correlation
Description
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.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Fibrosis Score Validity to Liver Biopsy Results
Description
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
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Korman, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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