Stratify Methotrexate
Research type
Research Study
Full title
A Study to Investigate the Liver Function of Patients taking Methotrexate, and risk stratify them accordingly
IRAS ID
264991
Contact name
Lucy Turner
Contact email
Sponsor organisation
York Teaching Hospital NHS Foundation Trust
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
Methotrexate is a drug widely prescribed, however the most appropriate method of monitoring is debated and currently unclear, demonstrated by divergent guidelines across specialities. Historically concerns have been raised regarding methotrexate and the development of liver fibrosis; more recent publications have cast doubt upon this potential relationship.
The discovery of novel, non-invasive methods to assess liver fibrosis, such as transient elastography (e.g. FibroScan®) have allowed fresh consideration into this difficult area.
This study aims to assess the prevalence of liver fibrosis (by way of FibroScan®, blood tests and clinician review) in participants who are taking methotrexate, compared with those who have never taken this drug.
Participants will be recruited largely from rheumatology and dermatology outpatient clinics in York and Scarborough Hospitals. Over the 12 month study period we will aim to recruit 698 patients. Controls will be matched by age and gender. 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.
The research group aim to demonstrate that liver fibrosis will be equal in both cohorts, regardless of MTX use. This data will inform the development of a clinical risk stratification pathway for patients about to commence MTX as well as guidance on monitoring such patients once MTX has been initiated. Further analysis planned on the data-set would be to compare and contrast FibroScan®scores with liver blood tests, and to perform regression analysis to assess relevant risk factors, of which the researcher’s presume metabolic syndrome will be most relevant.
The study will recruit for 12 months and analysis will take a further 12 months.
REC name
North East - York Research Ethics Committee
REC reference
19/NE/0176
Date of REC Opinion
17 Jun 2019
REC opinion
Further Information Favourable Opinion