IgG-4 Levels in Systemic Sclerosis

Systemic Sclerosis Clinical Trial

— SSc-IgG4  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04219592
• Other study ID #: MMC-110-19
• Status: Active, not recruiting
• Start date: May 30, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: January 2020
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 154
• Est. completion date: February 28, 2020
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• SSc patients

Exclusion Criteria:

• other chronic co-morbidities

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Diagnostic Test:
• IgG4 measurement (non-interventional, just obtaining data from medical records)
IgG4 measurement in mg/dL

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IgG4 measurement	quantifying IgG4 in each group and in SSc subgroups based on disease type, organs involved, medications.	4 months