Systemic SclerosisSSc-IgG4NCT04219592
IgG-4 Levels in Systemic Sclerosis
An observational study of Systemic Sclerosis, run by Meir Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- IgG4 measurement (non-interventional, just obtaining data from medical records)
- How many people
- 154 participants
- Where
- 1 siteIsrael
- Study dates
- 30 May 2019to 30 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Medical records of SSc patients from Meir Medical Center
Who may be able to join
- SSc patients
Who cannot join
- other chronic co-morbidities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing IgG-4 Levels in Systemic Sclerosis Patients vs. Healthy Controls
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.
- Conditions
- Systemic Sclerosis
- Being tested
- IgG4 measurement (non-interventional, just obtaining data from medical records)
- Keywords
- SSc, IgG4
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IgG4 measurement (non-interventional, just obtaining data from medical records)Diagnostic test
IgG4 measurement in mg/dL
| Study group | Role | What they receive |
|---|---|---|
| SSc | 74 SSc patients aged 18 - 85 Receives: Diagnostic Test: IgG4 measurement (non-interventional, just obtaining data from medical records) | |
| Healthy controls | 80 Healthy blood-donors aged 18 - 85 Receives: Diagnostic Test: IgG4 measurement (non-interventional, just obtaining data from medical records) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IgG4 measurement
quantifying IgG4 in each group and in SSc subgroups based on disease type, organs involved, medications.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start30 May 2019
- Primary completion30 Sep 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noa Rabinowicz, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219592
- Sponsor's protocol ID
- MMC-110-19
- Acronym
- SSc-IgG4
- Status last verified
- May 2025
- First submitted
- 5 Jan 2020
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not relevant
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing IgG-4 Levels in Systemic Sclerosis Patients vs. Healthy Controls
- ClinicalTrials.gov ID
- NCT04219592
- Acronym / sponsor ID
- SSc-IgG4 / MMC-110-19
- Conditions
- Systemic Sclerosis
- Keywords
- SSc, IgG4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 30 May 2019 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 7 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SSc | – | Diagnostic Test: IgG4 measurement (non-interventional, just obtaining data from medical records)74 SSc patients aged 18 - 85 |
| Healthy controls | – | Diagnostic Test: IgG4 measurement (non-interventional, just obtaining data from medical records)80 Healthy blood-donors aged 18 - 85 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Medical records of SSc patients from Meir Medical Center
Key inclusion criteria (1 listed)
- SSc patients
Key exclusion criteria (1 listed)
- other chronic co-morbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IgG4 measurement (non-interventional, just obtaining data from medical records)IgG4 measurement in mg/dL | Diagnostic test | Healthy controls, SSc |
Primary outcome
IgG4 measurement
Time frame: 4 months
quantifying IgG4 in each group and in SSc subgroups based on disease type, organs involved, medications.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No. not relevant
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IgG4 measurement (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.