Lupus ErythematosusR-PA14098NCT02891213
Study of the Role of Soluble Forms of RAGE (sRAGE/esRAGE) as Diagnostic and Prognostic Biomarkers of Systemic Lupus Erythematosus.
An observational study of Lupus Erythematosus, run by CHU de Reims at 1 site in France.
Trial summary
Systemic Lupus Erythematosus (SLE) is the most common systemic autoimmune disease. The clinical manifestations are severe and affect multiple target organs such as the kidney, central nervous system, skin, heart and joints. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Erythematosus
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2016to Oct 2017
- 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: Study population is the cohort of lupic patients have been included in "Lupus BioBanque du Rhin Supérieur".
Who may be able to join
- patients have been included in the LBBR biobank
- absence of immunomodulatory treatment,
- preserved renal function (MDRD> 60ml/min).
Who cannot join
- renal failure defined by MDRD clearance < 60 mL/min/m2,
- neoplasia,
- diabetes,
- other autoimmune disease,
- current immunosuppressive treatments.
Trial locations and contacts
1 site in 1 country.
Fatouma TOURE contact
Antoine GOURY contact
France1 site
Chu de Reims
Reims, France, 51092
Fatouma TOURE, ftoure@chu-reims.fr
Antoine GOURY, gouryantoine@gmail.com
About this study
Systemic Lupus Erythematosus (SLE) is the most common systemic autoimmune disease. The clinical manifestations are severe and affect multiple target organs such as the kidney, central nervous system, skin, heart and joints. Despite the progress made in the therapeutic approach with new immunosuppressive regimens, morbi-mortality is still high. Therefore, it's important to identify new biomarkers to help clinicians to predict severity and evolution of the disease for better adaptation of treatments and try to improve the prognosis.
RAGE (Receptor for Advanced Glycation Endproducts) :
Read more
RAGE (Receptor for Advanced Glycation Endproducts) is an ubiquitous membrane receptor, involved in development of many diseases such as diabetes, chronic renal failure but also in vascular remodelling, inflammatory, infectious deseases and cancer. RAGE regulates a number of crucial cell processes like inflammation, and tissue and cellular homeostasis.
RAGE is able to bind not only the advanced glycation end products (AGEs) such as pentosidine, carboxymethyllysine (CML), methyl-glyoxal-hydroimidazolone-1 (MG- H1), but also other ligands such as HMGB1 (high mobility group box1), and S100A8/A9 proteins which have been correlated in recent studies to the activity index of SLE. The activation of RAGE leads to a cascade of intracellular signaling and activation of the transcription factor NF-ΚB . NF-ΚB enable the traduction of proinflammatory cytokines such as IL-6, IL-1α ,IFN-γ. In SLE, these cytokines involved in perpetuation of inflammation and tissue damages including lupus nephritis. Moreover, the activation of RAGE induces the expression of adhesion molecule such as sICAM -1 and sVCAM -1 wich were recently involved in SLE vasculitis.
Soluble forms of RAGE, sRAGE and esRAGE :
RAGE is a proinflammatory membrane receptor. But RAGE also exists in soluble plasma forms, esRAGE (secreted form) and sRAGE (a truncated form as cleaved by MMP9 and ADAM10 enzymes). esRAGE and sRAGE have the same ligand-binding specificity as RAGE and may function as a 'decoy receptor' by binding pro-inflammatory ligands and preventing them from accessing cell surface RAGE (Kierdorf and Fritz, 2013). Therefore, both soluble forms have an anti-inflammatory action. Several studies have shown a decrease in circulating levels of sRAGE in patients with Rheumatoid Arthritis, or Sjögren Syndrome compared with healthy controls. However, the role of RAGE in SLE remains unknown.
RAGE and Systemic Lupus Erythematosus, recent advances :
Our team (Laboratory of Nephrology, CNRS UMR 7369, URCA) showed in a study in lupus RAGE knockout mice (B6/ MRL-FAS lpr/J RAGE-/-) a strong involvement of RAGE in systemic manifestations SLE. Recently, another report showed that sRAGE has an anti-inflammatory effect on the lupus nephritis and could be a potent therapy in mice.
In humans, two studies show a correlation between the plasma level of sRAGE and lupus phenotype ( Nienhuis et al. , 2008).
Working hypothesis :
Based on the results and those of the current studies, the investigators think that RAGE axis and its soluble forms play a crucial role in the complex pathogenesis of SLE.
The investigators hypothesize that plasma levels sRAGE and esRAGE are a reflection of the activity and the development of SLE in humans. Soluble forms of RAGE and ligands may be novel biomarkers of SLE and sRAGE a potent therapeutic target.
Read the detailed description
Expected results :
The investigators expect a correlation between serum sRAGE, esRAGE and activity of SLE and the presence of visceral involvement. Furthermore this study will allow us to analyze for the first time in a lupus population, the correlation between soluble forms of RAGE (esRAGE, sRAGE) and cytokines and molecules involved in lupus visceral involvement as IL-6, IL-1α, IFN-γ, sICAM-1 and sVCAM-1.
Completion of our project, will allow better understanding of the role of RAGE and RAGE ligand in SLE activity and will provide rationale for prospective study.
Future perspectives will include assessment of the risk-benefit for the use of anti-RAGE strategies or recombinant sRAGE/esRAGE molecules as adjuvant treatment for SLE.
Study Design : the investigators designed an retrospective, analytic, transversal, mulitcentric study. the investigators would like to use the serum and the clinical information collected in "Lupus BioBanque du Rhin Supérieur" (LBBR UF 9882) to measure soluble forms of RAGE, RAGE-ligands, cytokines, and sICAM and sVCAM. The investigators would like to include 150 patients in this study.
Aim 1: The main objective of this study is to investigate the association between Systemic Lupus Erythematosus (SLE) activity as measured by the SLEDAI score and serum concentrations of sRAGE and esRAGE.
Aim 2 : The study of the correlation between the activity of other activity markers of SLE and soluble forms of RAGE :
- the concentration of RAGE ligands (AGEs like CML, pentosidine and MG-H1) and soluble forms of RAGE (esRAGE, sRAGE)
- the cytokine profile (IL-6, IL-1α, IFN-γ) and soluble forms of RAGE (esRAGE, sRAGE)
- The concentrations of sICAM-1 and sVCAM-1 and soluble forms of RAGE (esRAGE, sRAGE)
Methods :
Inclusion criteria are :
- the LBBR inclusion criteria
- and Absence of immunomodulatory treatment,
- and preserved renal function (MDRD> 60ml/min).
Exclusion criteria are :
- renal failure defined by MDRD clearance < 60 mL/min/m2,
- or neoplasia,
- or diabetes,
- or other autoimmune disease,
- or current immunosuppressive treatments.
Data collection : About 500 μl of serum will be necessary for each patients to make all measurements.
Mass spectrometry will be used for measurement of RAGE ligands (Advanced glycation end products such as CML, pentosidine and MG-H1).
Commercially available ELISA kits will be used for measurement of sRAGE, esRAGE, sVCAM1.
Flow Cytometry will be used for measurement of cytokines (IL-6, IL-1a, IFN-y) and sICAM1.
- Conditions
- Lupus Erythematosus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LE (Lupus Erythematosus) group | * Samples of the LE (Lupus Erythematosus) group from a specimen collection : "Lupus BioBanque du Rhin Supérieur" (LBBR UF 9882). * It's a historical cohort of lupic patients which samples have been collected from many centers in France and Germany and stored in a biobank "Lupus BioBanque du Rhin Supérieur" (project : LBBR UF 9882). |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of RAGE ligands
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionJan 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891213
- Sponsor's protocol ID
- PA14098
- Acronym
- R-PA14098
- Status last verified
- Sep 2016
- First submitted
- 1 Sep 2016
- Last updated
- 23 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Role of Soluble Forms of RAGE (sRAGE/esRAGE) as Diagnostic and Prognostic Biomarkers of Systemic Lupus Erythematosus.
- ClinicalTrials.gov ID
- NCT02891213
- Acronym / sponsor ID
- R-PA14098 / PA14098
- Conditions
- Lupus Erythematosus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 7 Sep 2016 (estimated)
- 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.
Systemic Lupus Erythematosus (SLE) is the most common systemic autoimmune disease. The clinical manifestations are severe and affect multiple target organs such as the kidney, central nervous system, skin, heart and joints. Despite the progress made in the therapeutic approach with new immunosuppressive regimens, morbi-mortality is still high. Therefore, it's important to identify new biomarkers to help clinicians to predict severity and evolution of the disease for better adaptation of treatments and try to improve the prognosis.
RAGE (Receptor for Advanced Glycation Endproducts) :
RAGE (Receptor for Advanced Glycation Endproducts) is an ubiquitous membrane receptor, involved in development of many diseases such as diabetes, chronic renal failure but also in vascular remodelling, inflammatory, infectious deseases and cancer. RAGE regulates a number of crucial cell processes like inflammation, and tissue and cellular homeostasis.
RAGE is able to bind not only the advanced glycation end products (AGEs) such as pentosidine, carboxymethyllysine (CML), methyl-glyoxal-hydroimidazolone-1 (MG- H1), but also other ligands such as HMGB1 (high mobility group box1), and S100A8/A9 proteins which have been correlated in recent studies to the activity index of SLE. The activation of RAGE leads to a cascade of intracellular signaling and activation of the transcription factor NF-ΚB . NF-ΚB enable the traduction of proinflammatory cytokines such as IL-6, IL-1α ,IFN-γ. In SLE, these cytokines involved in perpetuation of inflammation and tissue damages including lupus nephritis. Moreover, the activation of RAGE induces the expression of adhesion molecule such as sICAM -1 and sVCAM -1 wich were recently involved in SLE vasculitis.
Soluble forms of RAGE, sRAGE and esRAGE :
RAGE is a proinflammatory membrane receptor. But RAGE also exists in soluble plasma forms, esRAGE (secreted form) and sRAGE (a truncated form as cleaved by MMP9 and ADAM10 enzymes). esRAGE and sRAGE have the same ligand-binding specificity as RAGE and may function as a 'decoy receptor' by binding pro-inflammatory ligands and preventing them from accessing cell surface RAGE (Kierdorf and Fritz, 2013). Therefore, both soluble forms have an anti-inflammatory action. Several studies have shown a decrease in circulating levels of sRAGE in patients with Rheumatoid Arthritis, or Sjögren Syndrome compared with healthy controls. However, the role of RAGE in SLE remains unknown.
RAGE and Systemic Lupus Erythematosus, recent advances :
Our team (Laboratory of Nephrology, CNRS UMR 7369, URCA) showed in a study in lupus RAGE knockout mice (B6/ MRL-FAS lpr/J RAGE-/-) a strong involvement of RAGE in systemic manifestations SLE. Recently, another report showed that sRAGE has an anti-inflammatory effect on the lupus nephritis and could be a potent therapy in mice.
In humans, two studies show a correlation between the plasma level of sRAGE and lupus phenotype ( Nienhuis et al. , 2008).
Working hypothesis :
Based on the results and those of the current studies, the investigators think that RAGE axis and its soluble forms play a crucial role in the complex pathogenesis of SLE.
The investigators hypothesize that plasma levels sRAGE and esRAGE are a reflection of the activity and the development of SLE in humans. Soluble forms of RAGE and ligands may be novel biomarkers of SLE and sRAGE a potent therapeutic target.
Detailed description
Expected results :
The investigators expect a correlation between serum sRAGE, esRAGE and activity of SLE and the presence of visceral involvement. Furthermore this study will allow us to analyze for the first time in a lupus population, the correlation between soluble forms of RAGE (esRAGE, sRAGE) and cytokines and molecules involved in lupus visceral involvement as IL-6, IL-1α, IFN-γ, sICAM-1 and sVCAM-1.
Completion of our project, will allow better understanding of the role of RAGE and RAGE ligand in SLE activity and will provide rationale for prospective study.
Future perspectives will include assessment of the risk-benefit for the use of anti-RAGE strategies or recombinant sRAGE/esRAGE molecules as adjuvant treatment for SLE.
Study Design : the investigators designed an retrospective, analytic, transversal, mulitcentric study. the investigators would like to use the serum and the clinical information collected in "Lupus BioBanque du Rhin Supérieur" (LBBR UF 9882) to measure soluble forms of RAGE, RAGE-ligands, cytokines, and sICAM and sVCAM. The investigators would like to include 150 patients in this study.
Aim 1: The main objective of this study is to investigate the association between Systemic Lupus Erythematosus (SLE) activity as measured by the SLEDAI score and serum concentrations of sRAGE and esRAGE.
Aim 2 : The study of the correlation between the activity of other activity markers of SLE and soluble forms of RAGE :
- the concentration of RAGE ligands (AGEs like CML, pentosidine and MG-H1) and soluble forms of RAGE (esRAGE, sRAGE)
- the cytokine profile (IL-6, IL-1α, IFN-γ) and soluble forms of RAGE (esRAGE, sRAGE)
- The concentrations of sICAM-1 and sVCAM-1 and soluble forms of RAGE (esRAGE, sRAGE)
Methods :
Inclusion criteria are :
- the LBBR inclusion criteria
- and Absence of immunomodulatory treatment,
- and preserved renal function (MDRD> 60ml/min).
Exclusion criteria are :
- renal failure defined by MDRD clearance < 60 mL/min/m2,
- or neoplasia,
- or diabetes,
- or other autoimmune disease,
- or current immunosuppressive treatments.
Data collection : About 500 μl of serum will be necessary for each patients to make all measurements.
Mass spectrometry will be used for measurement of RAGE ligands (Advanced glycation end products such as CML, pentosidine and MG-H1).
Commercially available ELISA kits will be used for measurement of sRAGE, esRAGE, sVCAM1.
Flow Cytometry will be used for measurement of cytokines (IL-6, IL-1a, IFN-y) and sICAM1.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LE (Lupus Erythematosus) group | – | –* Samples of the LE (Lupus Erythematosus) group from a specimen collection : "Lupus BioBanque du Rhin Supérieur" (LBBR UF 9882). * It's a historical cohort of lupic patients which samples have been collected from many centers in France and Germany and stored in a biobank "Lupus BioBanque du Rhin Supérieur" (project : LBBR UF 9882). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population is the cohort of lupic patients have been included in "Lupus BioBanque du Rhin Supérieur".
Key inclusion criteria (3 listed)
- patients have been included in the LBBR biobank
- absence of immunomodulatory treatment,
- preserved renal function (MDRD> 60ml/min).
Key exclusion criteria (5 listed)
- renal failure defined by MDRD clearance < 60 mL/min/m2,
- neoplasia,
- diabetes,
- other autoimmune disease,
- current immunosuppressive treatments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
concentration of RAGE ligands
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
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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.
Fatouma TOURE contact
Antoine GOURY contact
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 Lupus Erythematosus, run by CHU de Reims at 1 site 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 Sep 2016. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatouma TOURE (ftoure@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concentration of RAGE ligands (time frame: Day 1). 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 23 Sep 2016.