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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

ftoure@chu-reims.fr

Antoine GOURY contact

gouryantoine@gmail.com

France1 site
  • Chu de Reims

    Reims, France, 51092

    Fatouma TOURE, ftoure@chu-reims.fr

    Antoine GOURY, gouryantoine@gmail.com

Other trials in France

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 :

  1. the concentration of RAGE ligands (AGEs like CML, pentosidine and MG-H1) and soluble forms of RAGE (esRAGE, sRAGE)
  2. the cytokine profile (IL-6, IL-1α, IFN-γ) and soluble forms of RAGE (esRAGE, sRAGE)
  3. 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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02891213
Study groupRoleWhat 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.

  1. 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.

  1. First posted7 Sep 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionJan 2017 (estimated)
  4. Study completionOct 2017 (estimated)

Resources

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)
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

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.

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