Hepatic Steatosis and Fibrosis in Rheumatoid Arthritis Pa... | NCT05679648

Studies
Hepatic Steatosis and Fibrosis in Rheumatoid Arthritis Patients

NCT05679648

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Apr 12, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Hepatic Steatosis and Fibrosis in Rheumatoid Arthritis Patients

Interventions

ultrasonography

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2023Estimated

Primary Completion Date

Aug 1, 2023Estimated

Completion Date

Dec 1, 2023Estimated

First Submitted Date

Dec 25, 2022

First Submission Date that Met QC Criteria

Jan 10, 2023

First Posted Date

Jan 11, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2023

Last Update Posted Date

Apr 12, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rheumatoid arthritis patients			Diagnostic Test: ultrasonography
control			Diagnostic Test: ultrasonography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ultrasonography	Diagnostic Test	studying degree of steatosis	Rheumatoid arthritis patients control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The outpatient clinic of the Rheumatology Department in Sohag University

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amr Ahmed, Lecturer	Contact	02/01007065530		amr.hamed@med.sohag.edu.eg

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005234	Fatty Liver
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D001168	Arthritis
D007592	Joint Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014463	Ultrasonography

Ancestor Terms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided