Lupus Erythematosus, SystemicRFPLNCT03896373
Role of the Neonatal Fc Receptor for IgG in the Pathophysiology of Lupus
An observational study of Lupus Erythematosus, Systemic, run by University Hospital, Tours at 2 sites in France.
Trial summary
This study evaluates the expression of the neonatal fc receptor (FcRn) in white blood cells and antigen-presenting cells (APC) in active lupus patients compared to inactive lupus patients and control to investigate if it's upregulated or not. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- Blood samples
- How many people
- 48 participants
- Where
- 2 sitesFrance
- Study dates
- 17 Apr 2019to 18 Oct 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patient included are hospitalised in the university hospital of Tours in France
Who may be able to join
- Lupus erythematosus newly diagnosed or active
- Inactive lupus erythematosus
- Needing a blood sample for diagnosis or follow up
- Signed informed consent
Who cannot join
- Other auto immune disease
- Pregnant or brest feeding
- Legal protection or protected adults
Trial locations and contacts
2 sites in 1 country.
France2 sites
Internal Medicine Service, University Hospital, Tours
Tours, 37044
Nephrology Service, University Hospital, Tours
Tours, 37044
About this study
This study evaluates the expression of the neonatal fc receptor (FcRn) in white blood cells and antigen-presenting cells (APC) in active lupus patients compared to inactive lupus patients and control to investigate if it's upregulated or not.
Read the detailed description
FcRn is an intracellular receptor which binds the Fc of immunoglobulins G (IgG) and albumin which induce an upgraded half-life of this two proteins.
It's extended role involve the regulation of immune complexes and anti-tumoral immunity, some studies showing a direct correlation between it's expression and the tumor surface and prognosis.
Recently a role in the upregulation of humoral response with a increase of the antibodies's diversity and a more efficient priming of lymphocyte B have been evocated.
The lupus erythematosus is an auto-immune disease mediated by IgG and immune complexes characterized by a high diversity of autoantibodies and a large dysregulation of the immune system in all it's components.
In this study, by analogy with the founding in anti-tumoral immunity, the investigators hypothesised that in an active lupus disease the expression of FcRn is upregulated in the white blood cells and in APC.
This is followed by an extended half life of IgG autoantibodies and immune complexes inducing direct damages by their deposit in tissues and indirectly by upregulating the humoral response, leading to anormal production of a large panel of autoantibodies.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- Blood samples
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
Blood samples
| Study group | Role | What they receive |
|---|---|---|
| Lupus erythematosus | Patients with inactive lupus erythematosus, active lupus erythematosus or newly diagnosed Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of FcRn in active or newly diagnosed lupus erythematosus compared with inactive lupus erythematosus
Measurement in flow cytometry of the fluorescence's mean of FcRn in each type of white blood cells
Measured: At baseline
Secondary outcomes (4)
FcRn genotyping (FCGRT)
FcRn gene polymorphism analysis (FCGRT)
Measured: At baseline
IGHG1 genotyping
IGHG1 gene polymorphism analysis
Measured: At baseline
Expression of FcRn in CD16 monocytes
CD16 is used to differentiate subpopulation of monocytes. The investigators will evaluate the correlation between expression of CD16 and the fluorescence's mean of FcRn measured in flowcytometry.
This measure will be done for each population of participants
Measured: At baseline
Expression of FcRn in macrophages
After a positive selection of monocytes obtained from participants, the investigators will measure the fluorescence's mean of FcRn in this cells for each population of participants
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start17 Apr 2019
- Primary completion18 Oct 2020
- Study completion18 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie GOUILLEUX, PhD, Study director, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03896373
- Sponsor's protocol ID
- RIPH3-RNI18/RFPL
- Other IDs
- 2019-A00394-53
- Acronym
- RFPL
- Status last verified
- Feb 2021
- First submitted
- 27 Mar 2019
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Neonatal Fc Receptor for IgG in the Pathophysiology of Lupus
- ClinicalTrials.gov ID
- NCT03896373
- Acronym / sponsor ID
- RFPL / RIPH3-RNI18/RFPL
- Conditions
- Lupus Erythematosus, Systemic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 18 Oct 2020 (actual)
- Study completion
- 18 Oct 2020 (actual)
- First posted
- 1 Apr 2019 (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 study evaluates the expression of the neonatal fc receptor (FcRn) in white blood cells and antigen-presenting cells (APC) in active lupus patients compared to inactive lupus patients and control to investigate if it's upregulated or not.
Detailed description
FcRn is an intracellular receptor which binds the Fc of immunoglobulins G (IgG) and albumin which induce an upgraded half-life of this two proteins.
It's extended role involve the regulation of immune complexes and anti-tumoral immunity, some studies showing a direct correlation between it's expression and the tumor surface and prognosis.
Recently a role in the upregulation of humoral response with a increase of the antibodies's diversity and a more efficient priming of lymphocyte B have been evocated.
The lupus erythematosus is an auto-immune disease mediated by IgG and immune complexes characterized by a high diversity of autoantibodies and a large dysregulation of the immune system in all it's components.
In this study, by analogy with the founding in anti-tumoral immunity, the investigators hypothesised that in an active lupus disease the expression of FcRn is upregulated in the white blood cells and in APC.
This is followed by an extended half life of IgG autoantibodies and immune complexes inducing direct damages by their deposit in tissues and indirectly by upregulating the humoral response, leading to anormal production of a large panel of autoantibodies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lupus erythematosus | – | Other: Blood samplesPatients with inactive lupus erythematosus, active lupus erythematosus or newly diagnosed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patient included are hospitalised in the university hospital of Tours in France
Key inclusion criteria (4 listed)
- Lupus erythematosus newly diagnosed or active
- Inactive lupus erythematosus
- Needing a blood sample for diagnosis or follow up
- Signed informed consent
Key exclusion criteria (3 listed)
- Other auto immune disease
- Pregnant or brest feeding
- Legal protection or protected adults
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 |
|---|---|---|
| Blood samplesBlood samples | Other | Lupus erythematosus |
Primary outcome
Expression of FcRn in active or newly diagnosed lupus erythematosus compared with inactive lupus erythematosus
Time frame: At baseline
Measurement in flow cytometry of the fluorescence's mean of FcRn in each type of white blood cells
4 secondary outcomes
FcRn genotyping (FCGRT)
Time frame: At baseline
IGHG1 genotyping
Time frame: At baseline
Expression of FcRn in CD16 monocytes
Time frame: At baseline
Expression of FcRn in macrophages
Time frame: At baseline
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 24 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
Valérie GOUILLEUX, PhD study director
University Hospital, Tours
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Erythematosus, Systemic, run by University Hospital, Tours at 2 sites in France.
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 4 inclusion and 3 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 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Expression of FcRn in active or newly diagnosed lupus erythematosus compared with inactive lupus erythematosus (time frame: At baseline). 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 24 Feb 2021.