Liver Fibrosis Risk With Methotrexate Exposure
Rheumatoid Artritis · Psoriatic Arthritis · Liver Fibrosis · Methotrexate Adverse Reaction
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Observational
- Phase
- Not applicable / not listed
- Age range
- 18 years - 70 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 200 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
METOHEP is a cross-sectional observational study with the aim to study associations of methotrexate (MTX) exposure and metabolic characteristics with non-invasive liver stiffness and steatosis in rheumatoid arthritis (RA) and psoriatic arthritis (PsA).
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- Patients with a diagnosis of RA or PsA followed at the Department of Rheumatology at Sahlgrenska University Hospital, Gothenburg, Sweden
- Age 18-70
- Ongoing treatment with methotrexate
- Available data of MTX initiation date, treatment duration and cumulative exposure
Exclusion Criteria:
- other rheumatic diseases than RA och PsA
- known chronic liver disease
- active hepatitis B or C infection
Study population
Patients with RA och PsA followed at the Department of Rheumatology at Sahlgrenska University Hospital, Gothenburg, Sweden
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not reported
- Masking
- Not reported
Patients with RA and PsA
Patients receiving MTX at assessment, for whom MTX initiation, current weekly dose, treatment duration and cumulative exposure could be established.
Reference group
Patients with RA or PsA with no prior methotrexate exposure
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Liver stiffness measured using transient elastography (FibroScan Mini 430, Echosens)
Time frame: One examination at enrollment
FibroScan utilizes mechanical shear waves and ultrasound technology to assess the physical properties of liver tissue. Elevated liver stiffness is indicative of fibrosis.
Elevated liver stiffness was defined as FibroScan ≥7.1 kPa, using pre-specified cutoffs
Liversteatosis measured with controlled attenuation parameter (CAP)
Time frame: One examination at enrollment
Cap measures the degree of ultrasound beam attenuation caused by intracellular lipid droplets to non-invasively estimate hepatic steatosis in decibels per meter (dB/m).
Grade 0, no steatosis: CAP\<238 dB/m Grade 1, mild steatosis: CAP 238-259 dB/m Grade 2, moderate steatosis: CAP 260-290 dB/m Grade 3, severe steatosis: CAP \>290 dB/m
Secondary measures
Liverstiffness measured with acoustic radiation force impulse (ARFI)
Time frame: One examination at enrollment
ARFI imaging is an ultrasound-based elastography technique used for the non-invasive quantification of tissue mechanical properties, primarily tissue stiffness.
Elevated liver stiffness was defined as ARFI ≥5.1 kPa, using pre-specified cutoffs
Blood-based liver fibrosis index: the fibrosis-4 index (FIB-4)
Time frame: One examination at enrollment
FIB-4 = age × AST / \[platelet count × √ALT\], using transaminase activities in U/L and platelet count in ×10⁹/L.
Range min 0.1 - max 40. (Theoretically \>0- infinity) FIB-4 \<1.3 high negative predictive value, ruling out advanced hepatic fibrosis.
FIB-4 \>3.25 highly suggestive of advanced hepatic fibrosis or established cirrhosis
Blood-based liver fibrosis index: the aspartate aminotransferase-to-platelet ratio index (APRI)
Time frame: One examination at enrollment
APRI = \[(AST / 40 U/L) / platelet count\] × 100 Range: min 0.1- max 20 (Theoretically \>0- infinity) APRI \<0.5 high negative predictive value, ruling out advanced hepatic fibrosis APRI \>2.0 highly suggestive of advanced hepatic fibrosis or established cirrhosis
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Sahlgrenska University Hospital, Department of RheumatologyGothenburg, SwedenStatus unknown
Study team and timeline
- Lead sponsor
- Vastra Gotaland Region
- Study start
- Jun 1, 2023 Actual
- Primary completion
- Apr 30, 2025 Actual
- Study completion
- Apr 30, 2025 Actual
- First posted
- Nov 10, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Comprehensive Assessment of Risk for Liver Fibrosis in Long-term Methotrexate Therapy (METOHEP)
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026