Liver FibrosisNCT06872073
Assessment of Methotreaxate-induced Liver Fibrosis by Transient Elastography and Serological Markers
An observational study of Liver Fibrosis, run by Assiut University.
Trial summary
Methotrexate (MTX), a folic acid analogue, inhibits the synthesis of purines and pyrimidines and is widely used in the treatment of chronic inflammatory diseases, particularly Rheumatoid arthritis (RA). It is typically the first-line drug for RA management. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Liver Fibrosis
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adults (18 years and older) prescribed Methotrexate therapy for Rheumatological disease (such as Systemic Lupus Erythematosus , Rheumatoid arthritis and Ankylosing spondylitis)or Dermatological diseases (such as Psoriasis and Behcets disease).
Who may be able to join
- Adults (18 years and older) prescribed Methotrexate therapy for Rheumatological disease (such as Systemic Lupus Erythematosus , Rheumatoid arthritis and Ankylosing spondylitis)or Dermatological diseases (such as Psoriasis and Behcets disease).
Who cannot join
- Patients with metabolic associated fatty liver disease (MAFLD). Patients with chronic liver diseases (HBV, HCV, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, alcoholic liver disease).
- History of chronic heart failure or renal failure.c.
About this study
Methotrexate (MTX), a folic acid analogue, inhibits the synthesis of purines and pyrimidines and is widely used in the treatment of chronic inflammatory diseases, particularly Rheumatoid arthritis (RA). It is typically the first-line drug for RA management. However, prolonged MTX use is associated with hepatotoxicity, including liver fibrosis (LF), which necessitates regular monitoring, especially of liver function tests MTX-induced liver injury has been recognized since the early 1970and numerous studies have shown an increased risk of liver fibrosis, which is estimated to occur in approximately 5% of patients, with a potential relationship to the cumulative dose of MTX Despite intensive monitoring strategies and the recommendation for liver biopsies, liver biopsy carry significant risk, including bleeding and sampling variability .
the aim of the study to Estimate the frequency and stage of liver fibrosis in patients with Rheumatological or Dermatological diseases receiving Methotrexate in Assuit University Hospitals in comparison to a control group with the same diseases not receiving Methotrexate.
Read more
Evaluate the diagnostic performance of FIB-4 , APRI and FIB-5 scores as non invasive fibrosis markers in comparison to Transient Elastography in these patients.
Identify the predictors of liver fibrosis in these patients. As such, there is increasing interest in non-invasive methods for monitoring liver fibrosis, such as liver stiffness measurement by FibroScan (FS), APRI score , FIB-4 score and FIB-5 score . These methods offer advantages over liver biopsy, including being non-invasive, rapid, reproducible, and able to assess disease progression over time. However, the prevalence of hepatic fibrosis in MTX-treated patients, particularly in Egypt, remains under-researched.
- Conditions
- Liver Fibrosis
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | patients prescribed Methotrexate therapy for Rheumatological disease (such as Systemic Lupus Erythematosus , Rheumatoid arthritis and Ankylosing spondylitis)or Dermatological diseases (such as Psoriasis and Behcets disease). | |
| Group B | patients with Rheumatological or Dermatological disease who have not received Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevelance of liver fibrosis
Estimate the frequency of liver fibrosis in patients with Rheumatological or Dermatological diseases receiving Methotrexate in Assuit University Hospitals
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, heba ali Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872073
- Sponsor's protocol ID
- MTX liver fibrosis TE
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Methotreaxate-induced Liver Fibrosis by Transient Elastography and Serological Markers
- ClinicalTrials.gov ID
- NCT06872073
- Acronym / sponsor ID
- MTX liver fibrosis TE
- Conditions
- Liver Fibrosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Methotrexate (MTX), a folic acid analogue, inhibits the synthesis of purines and pyrimidines and is widely used in the treatment of chronic inflammatory diseases, particularly Rheumatoid arthritis (RA). It is typically the first-line drug for RA management. However, prolonged MTX use is associated with hepatotoxicity, including liver fibrosis (LF), which necessitates regular monitoring, especially of liver function tests MTX-induced liver injury has been recognized since the early 1970and numerous studies have shown an increased risk of liver fibrosis, which is estimated to occur in approximately 5% of patients, with a potential relationship to the cumulative dose of MTX Despite intensive monitoring strategies and the recommendation for liver biopsies, liver biopsy carry significant risk, including bleeding and sampling variability .
the aim of the study to Estimate the frequency and stage of liver fibrosis in patients with Rheumatological or Dermatological diseases receiving Methotrexate in Assuit University Hospitals in comparison to a control group with the same diseases not receiving Methotrexate.
Evaluate the diagnostic performance of FIB-4 , APRI and FIB-5 scores as non invasive fibrosis markers in comparison to Transient Elastography in these patients.
Identify the predictors of liver fibrosis in these patients. As such, there is increasing interest in non-invasive methods for monitoring liver fibrosis, such as liver stiffness measurement by FibroScan (FS), APRI score , FIB-4 score and FIB-5 score . These methods offer advantages over liver biopsy, including being non-invasive, rapid, reproducible, and able to assess disease progression over time. However, the prevalence of hepatic fibrosis in MTX-treated patients, particularly in Egypt, remains under-researched.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –patients prescribed Methotrexate therapy for Rheumatological disease (such as Systemic Lupus Erythematosus , Rheumatoid arthritis and Ankylosing spondylitis)or Dermatological diseases (such as Psoriasis and Behcets disease). |
| Group B | – | –patients with Rheumatological or Dermatological disease who have not received Methotrexate |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adults (18 years and older) prescribed Methotrexate therapy for Rheumatological disease (such as Systemic Lupus Erythematosus , Rheumatoid arthritis and Ankylosing spondylitis)or Dermatological diseases (such as Psoriasis and Behcets disease).
Key inclusion criteria (1 listed)
- Adults (18 years and older) prescribed Methotrexate therapy for Rheumatological disease (such as Systemic Lupus Erythematosus , Rheumatoid arthritis and Ankylosing spondylitis)or Dermatological diseases (such as Psoriasis and Behcets disease).
Key exclusion criteria (2 listed)
- Patients with metabolic associated fatty liver disease (MAFLD). Patients with chronic liver diseases (HBV, HCV, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, alcoholic liver disease).
- History of chronic heart failure or renal failure.c.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevelance of liver fibrosis
Time frame: baseline
Estimate the frequency of liver fibrosis in patients with Rheumatological or Dermatological diseases receiving Methotrexate in Assuit University Hospitals
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
Related trials for Liver Fibrosis
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis
Cirrhosis, Portal Hypertension Related to Cirrhosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Fibrosis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevelance of liver fibrosis (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.