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CompletedNCT04219592SSc-IgG4Updated May 16, 2025

IgG-4 Levels in Systemic Sclerosis

An observational study in Systemic Sclerosis, sponsored by Meir Medical Center. Completed at 1 site in Israel. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-16.

Sponsored by Meir Medical Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
154
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Systemic Sclerosis

Keywords

  • SSc
  • IgG4
03

In context

Scleroderma, Systemic

688 studies on the registry are indexed under Scleroderma, Systemic; 223 are open to participants now.

This study's enrollment of 154 is above the median of 100 across 169 observational studies indexed under Scleroderma, Systemic.

Browse Scleroderma, Systemic studies →

Lead sponsor

Meir Medical Center is the lead sponsor of 389 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Medical records of SSc patients from Meir Medical Center

Inclusion criteria

  • SSc patients

Exclusion criteria

Exclusion Criteria:

  • other chronic co-morbidities
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
154 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • Diagnostic testIgG4 measurement (non-interventional, just obtaining data from medical records)

    IgG4 measurement in mg/dL

06

What researchers measure

Primary outcomes

  1. IgG4 measurement

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

    Time frame: 4 months

07

Study locations

1 site
  • Meir Medical Center
    Kfar Saba, Israel
08

References and documents

Individual participant data

Plan to share: No — not relevant

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04219592
Lead sponsor
Meir Medical Center
Responsible party
Noa Rabinowicz (Principal investigator, Meir Medical Center) — Principal investigator
First posted
Jan 7, 2020
Start date
May 30, 2019
Primary completion
Sep 30, 2024
Completion
Oct 30, 2024
Last update
May 16, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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