Liver Fibrosis Risk With Methotrexate Exposure
NCT07928921, Completed, Vastra Gotaland Region
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Liver Fibrosis Risk With Methotrexate Exposure | ClinicalTrials.gov |
| NCT number | NCT07928921 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Enrollment | 200 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Vastra Gotaland Region | ClinicalTrials.gov |
| Conditions | Rheumatoid Artritis, Psoriatic Arthritis, Liver Fibrosis, Methotrexate Adverse Reaction | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Liver stiffness measured using transient elastography (FibroScan Mini 430, Echosens) | 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 | ClinicalTrials.gov |
| Primary | Liversteatosis measured with controlled attenuation parameter (CAP) | 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 | ClinicalTrials.gov |
| Secondary | Liverstiffness measured with acoustic radiation force impulse (ARFI) | 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 | ClinicalTrials.gov |
| Secondary | Blood-based liver fibrosis index: the fibrosis-4 index (FIB-4) | 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 | ClinicalTrials.gov |
| Secondary | Blood-based liver fibrosis index: the aspartate aminotransferase-to-platelet ratio index (APRI) | 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 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)