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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN14696018
Enrollment
2000
Registered
2019-11-18
Start date
2019-06-25
Completion date
Unknown
Last updated
2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver fibrosis Digestive System Hepatic fibrosis

Interventions

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. Contr
including blood test results, duration and cumulative dose of MTX prescribed (if relevant), patient demographic data such as postcode, age and gender. The data will be recorded in an EXCEL file, with
they will be given adequate time and assisted for any special needs as appropriate. The questionnaire focusses on patients' understanding and knowledge of methotrexate. The answers are in both qualita

Sponsors

York Teaching Hospital NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Presence of liver fibrosis (by liver Fibroscan®)

Secondary

MeasureTime frame
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.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026