NCT05679648

Brief Summary

studying the prevalence of hepatic steatosis and fibrosis in a large scale of patients with RA and healthy controls

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

December 25, 2022

Last Update Submit

April 11, 2023

Conditions

Hepatic Steatosis and Fibrosis in Rheumatoid Arthritis Patients

Keywords

hepatic steatosisrheumatoid arthritis

Outcome Measures

Primary Outcomes (2)

  • degree of hepatic steatosis

    degree of hepatic steatosis by ultrasonography and Hepatic Steatosis Index.

    1 day during examination

  • degree of hepatic fibrosis

    degree of hepatic fibrosis by FIB-4 and APRI tests

    1 day during examination

Study Arms (2)

Rheumatoid arthritis patients

Diagnostic Test: ultrasonography

control

Diagnostic Test: ultrasonography

Interventions

ultrasonographyDIAGNOSTIC_TEST

studying degree of steatosis

Rheumatoid arthritis patientscontrol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The outpatient clinic of the Rheumatology Department in Sohag University

You may qualify if:

  • RA according to the American College of Rheumatology (ACR)/EULAR 2010 criteria (Aletaha et al., 2010)
  • Age≥18 years

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fatty LiverArthritis, Rheumatoid

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Amr Ahmed, Lecturer

CONTACT

02/01007065530amr.hamed@med.sohag.edu.eg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

December 25, 2022

First Posted

January 11, 2023

Study Start

June 1, 2023

Primary Completion

August 1, 2023

Study Completion

December 1, 2023

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share