Stratify methotrexate: a study to investigate the liver function of patients taking methotrexate, and risk-stratify them accordingly

Not Applicable

Suspended

• Conditions: iver fibrosis; Digestive System; Hepatic fibrosis

• Registration Number: ISRCTN14696018
• Lead Sponsor: York Teaching Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-18
• Last Update Posted: 27 July 2020
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. Individuals in the methotrexate cohort must have taken this medication for at least 6 months
2. All participants must be over 18 years old

Exclusion Criteria

1. Pregnant females
2. Previously taken methotrexate, but are no longer currently taking it
3. Lack capacity to consent

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of liver fibrosis (by liver Fibroscan®)

Secondary Outcome Measures

Name	Time	Method
Risk factors for liver fibrosis will be assessed for each participant e.g. presence of diabetes mellitus, BMI and body mass composition, current and previous alcohol use, cumulative dose and duration of methotrexate use etc.