IgG-4 Levels in Systemic Sclerosis

• Conditions: Systemic Sclerosis
• Interventions: Diagnostic Test: IgG4 measurement (non-interventional, just obtaining data from medical records)

• Registration Number: NCT04219592
• Lead Sponsor: Meir Medical Center

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.

Study Timeline

• Study Start: 2019-05-30
• Primary Completion: 2019-09-30
• Status Verified: 2020-01
• Study First Submitted: 2020-01-05
• Study First Submitted QC: 2020-01-05
• Study First Posted: 2020-01-07
• Last Update Submitted: 2020-01-07
• Last Update Posted: 2020-01-10
• Study Completion: 2020-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• SSc patients

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Exclusion Criteria

• other chronic co-morbidities

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy controls	IgG4 measurement (non-interventional, just obtaining data from medical records)	80 Healthy blood-donors aged 18 - 85
SSc	IgG4 measurement (non-interventional, just obtaining data from medical records)	74 SSc patients aged 18 - 85

Primary Outcome Measures

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

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel