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Completed

NCT Number: NCT04219592

IgG-4 Levels in Systemic Sclerosis

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Meir Medical Center

Kfar Saba, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • SSc patients

Exclusion criteria

  • other chronic co-morbidities

Treatment and study plan

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

Diagnostic Test

IgG4 measurement in mg/dL

Primary outcomes

  1. IgG4 measurement

    Time frame: 4 months

    quantifying IgG4 in each group and in SSc subgroups based on disease type, organs involved, medications.

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Official study title

Comparing IgG-4 Levels in Systemic Sclerosis Patients vs. Healthy Controls

Acronym: SSc-IgG4

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jan 7, 2020
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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