ClinicalTrials.gg
CompletedNCT07928921METOHEPUpdated Nov 10, 2026

Liver Fibrosis Risk With Methotrexate Exposure

An observational study in Rheumatoid Artritis, Psoriatic Arthritis and Liver Fibrosis, sponsored by Vastra Gotaland Region. Completed at 1 site in Sweden. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Vastra Gotaland Region · Observational

Updated Nov 10, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
200
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • Rheumatoid Artritis
  • Psoriatic Arthritis
  • Liver Fibrosis
  • Methotrexate Adverse Reaction
03

In context

Arthritis, Psoriatic

600 studies on the registry are indexed under Arthritis, Psoriatic; 129 are open to participants now.

This study's enrollment of 200 is below the median of 300 across 243 observational studies indexed under Arthritis, Psoriatic.

Browse Arthritis, Psoriatic studies →

Lead sponsor

Vastra Gotaland Region is the lead sponsor of 275 studies on the registry; 109 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with RA och PsA followed at the Department of Rheumatology at Sahlgrenska University Hospital, Gothenburg, Sweden

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • other rheumatic diseases than RA och PsA
  • known chronic liver disease
  • active or C infection
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Liver stiffness measured using transient elastography (FibroScan Mini 430, Echosens)

    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

    Time frame: One examination at enrollment

  2. Liversteatosis measured with controlled attenuation parameter (CAP)

    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

    Time frame: One examination at enrollment

Secondary outcomes

  1. Liverstiffness measured with acoustic radiation force impulse (ARFI)

    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

    Time frame: One examination at enrollment

  2. Blood-based liver fibrosis index: the fibrosis-4 index (FIB-4)

    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

    Time frame: One examination at enrollment

  3. Blood-based liver fibrosis index: the aspartate aminotransferase-to-platelet ratio index (APRI)

    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

    Time frame: One examination at enrollment

07

Study locations

1 site
  • Sahlgrenska University Hospital, Department of Rheumatology
    Gothenburg, 41345, Sweden
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2023 to primary completion in Apr 2025, 22 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 29, 2026
First posted
Nov 10, 2026
StartActual
Jun 1, 2023
Primary completionActual
Apr 30, 2025
CompletionActual
Apr 30, 2025
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07928921
Responsible party
Sponsor
First posted
Nov 10, 2026
Start date
Jun 1, 2023
Primary completion
Apr 30, 2025
Completion
Apr 30, 2025
Last update
Nov 10, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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