IgG-4 Levels in Systemic Sclerosis | NCT04219592

Studies
IgG-4 Levels in Systemic Sclerosis

NCT04219592

Sponsor

Meir Medical Center

Status

Completed

Last Update Posted

May 16, 2025Actual

Enrollment

154Actual

Phase

Not provided

Conditions

Systemic Sclerosis

Interventions

IgG4 measurement (non-interventional, just obtaining data from medical records)

Countries

Israel

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

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 30, 2019Actual

Primary Completion Date

Sep 30, 2024Actual

Completion Date

Oct 30, 2024Actual

First Submitted Date

Jan 5, 2020

First Submission Date that Met QC Criteria

Jan 5, 2020

First Posted Date

Jan 7, 2020Actual

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

May 13, 2025

Last Update Posted Date

May 16, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an observational - non interventional study. The investigators will compare IgG4 levels of 80 healthy donors (from Israel blood bank - MDA) and 80 Systemic Sclerosis patients from Meir Medical Center.

Detailed Description

IgG4 levels will be obtained from medical records of 80 SSc patients between the years 2000-2019. These will be compared to IgG4 levels from sera of 80 healthy donors (from Israel blood-bank - MDA). Correlations between IgG4 levels and the following will be made: age, sex, disease type (limited or diffused SSc), disease duration, medications.

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

Retention

Enrollment

154Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SSc		74 SSc patients aged 18 - 85	Diagnostic Test: IgG4 measurement (non-interventional, just obtaining data from medical records)
Healthy controls		80 Healthy blood-donors aged 18 - 85	Diagnostic Test: IgG4 measurement (non-interventional, just obtaining data from medical records)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IgG4 measurement (non-interventional, just obtaining data from medical records)	Diagnostic Test	IgG4 measurement in mg/dL	Healthy controls SSc

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IgG4 measurement	quantifying IgG4 in each group and in SSc subgroups based on disease type, organs involved, medications.	4 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

SSc patients

Exclusion Criteria:

other chronic co-morbidities

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Medical records of SSc patients from Meir Medical Center

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

not relevant

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012595	Scleroderma, Systemic

Ancestor Terms

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D012871	Skin Diseases

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Browse Branches

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