Hepatic Steatosis and Fibrosis in Rheumatoid Arthritis PatientsNCT05679648
Hepatic Steatosis and Fibrosis in Rheumatoid Arthritis Patients
An observational study of Hepatic Steatosis and Fibrosis in Rheumatoid Arthritis Patients, run by Sohag University.
Trial summary
studying the prevalence of hepatic steatosis and fibrosis in a large scale of patients with RA and healthy controls Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatic Steatosis and Fibrosis in Rheumatoid Arthritis Patients
- What is being tested?
- ultrasonography
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The outpatient clinic of the Rheumatology Department in Sohag University
Who may be able to join
- RA according to the American College of Rheumatology (ACR)/EULAR 2010 criteria (Aletaha et al., 2010)
- Age≥18 years
Who cannot join
- History of hepatitis B and C virus infection.
- Receiving hepatotoxic drugs other than RA-specific drugs.
- Alcohol abuse (i30 g/day in men and ⩾20 g/day in women).
- Diagnosis of Wilson's disease, α1-antitrypsin deficiency or hemochromatosis.
- Autoimmune liver disease.
- Cancer.
- Pregnancy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Hepatic Steatosis and Fibrosis in Rheumatoid Arthritis Patients: a Cross-sectional Case-control Study
studying the prevalence of hepatic steatosis and fibrosis in a large scale of patients with RA and healthy controls
- Being tested
- ultrasonography
- Keywords
- hepatic steatosis, rheumatoid arthritis
- Medical subject headings
- Fatty Liver, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographyDiagnostic test
studying degree of steatosis
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid arthritis patients | Not described Receives: Diagnostic Test: ultrasonography | |
| control | Not described Receives: Diagnostic Test: ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of hepatic steatosis
degree of hepatic steatosis by ultrasonography and Hepatic Steatosis Index.
Measured: 1 day during examination
degree of hepatic fibrosis
degree of hepatic fibrosis by FIB-4 and APRI tests
Measured: 1 day during examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Steatosis and Fibrosis in Rheumatoid Arthritis PatientsStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Hamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679648
- Sponsor's protocol ID
- Soh-Med-22-11-17
- Status last verified
- Apr 2023
- First submitted
- 25 Dec 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hepatic Steatosis and Fibrosis in Rheumatoid Arthritis Patients: a Cross-sectional Case-control Study
- ClinicalTrials.gov ID
- NCT05679648
- Acronym / sponsor ID
- Soh-Med-22-11-17
- Keywords
- hepatic steatosis, rheumatoid arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 11 Jan 2023 (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.
studying the prevalence of hepatic steatosis and fibrosis in a large scale of patients with RA and healthy controls
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid arthritis patients | – | Diagnostic Test: ultrasonography |
| control | – | Diagnostic Test: ultrasonography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The outpatient clinic of the Rheumatology Department in Sohag University
Key inclusion criteria (2 listed)
- RA according to the American College of Rheumatology (ACR)/EULAR 2010 criteria (Aletaha et al., 2010)
- Age≥18 years
Key exclusion criteria (7 listed)
- History of hepatitis B and C virus infection.
- Receiving hepatotoxic drugs other than RA-specific drugs.
- Alcohol abuse (i30 g/day in men and ⩾20 g/day in women).
- Diagnosis of Wilson's disease, α1-antitrypsin deficiency or hemochromatosis.
- Autoimmune liver disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasonographystudying degree of steatosis | Diagnostic test | Rheumatoid arthritis patients, control |
Primary outcome
degree of hepatic steatosis
Time frame: 1 day during examination
degree of hepatic steatosis by ultrasonography and Hepatic Steatosis Index.
degree of hepatic fibrosis
Time frame: 1 day during examination
degree of hepatic fibrosis by FIB-4 and APRI tests
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Steatosis and Fibrosis in Rheumatoid Arthritis Patients, run by Sohag 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr Ahmed, Lecturer (02/01007065530, amr.hamed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
degree of hepatic steatosis (time frame: 1 day during examination). The study lists 2 primary outcomes in all. 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 Apr 2023.