Prognosis Assessment of the Increase of GADD34 Gene Expression for Patient Suffering From Systemic Lupus Erythematosus

University Hospital, Grenoble143 enrolled

Overview

Given that GADD34 has been described as a potential key regulator of pro-inflammatory cytokine production in human and elevated blood marker in SLE patients, this study aim to prove that the GADD34 RNA level in mononuclear blood cells can be used as a prognostic marker to assess the risk of SLE flare.

Systemic lupus erythematosus (SLE) has a prevalence estimated between 1 and 6 per 10000 individuals and concerns over 30 000 patients in France for example. As of today, there isn't any reliable specific blood analysis that can be used to assess the prognosis of SLE, that means predict a SLE flare. The discovery of such a blood test could allow a better patients' monitoring in order to help doctors to better adapt treatments (lowering background treatments when they are not needed and increase them ahead of a potential flare when the risk assessment raises). In SLE patients, a recent study shows elevated levels of GADD34 RNA in mononuclear blood cells : higher than twice the control levels for 36 of the 60 SLE patients and ten times higher than the control levels for 13 of the 60 SLE patients. Given that GADD34 has been described as a potential key regulator of pro-inflammatory cytokine production in human and elevated blood marker in SLE patients, this study aim to prove that the GADD34 RNA level in mononuclear blood cells can be used as a prognostic marker to assess the risk of SLE flare.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

143

Conditions

Lupus Erythematosus

Interventions

GADD34 RNA level measurement.OTHER

Blood analysis including GADD34 RNA level measurement is performed every 3 months up to 1 year for SLE patients. A modal including physical exam, standard biological results and GADD34 RNA level is correlated to a SLE flare occurence in the next 3 months.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

* Inclusion Criteria: * man and women over 18 Years old. * suffering from SLE (American College of Rheumatology criteria). * without SLE flare for 3 months. * with a signed consent and social security affiliation (required in France). * Exclusion Criteria: * Viral infection within 15 days. * Other chronic inflammatory disease. * People with special protection (defined in articles : L1121- §5-8 et articles L3212-§1-3 of French health care law).

Locations (7)

CHU Grenoble

Grenoble, France

groupement hospitalier mutualiste de Grenoble

Grenoble, France

Hopital européen de Marseille

Marseille, France

CHU Marseille

Marseille, France

Outcomes

Primary Outcomes

GADD34 RNA level

GADD34 RNA level in mononuclear blood cells in the last 3 months before a SLE flare occurence. RNA levels have no unit,they are rates compared with a housekeeping gene RNA level as unit. To avoid any bias in primary outcome, SLE Flare occurence is assessed with both patient and investigator blinded from Gadd34 RNA level.

Time frame: Measured every 3 months, up to 1 year (5 blood samples).The Last result before a SLE flare occurence will be used.

Secondary Outcomes

Prognosis score of SLE flare occurence

Prognosis score of SLE flare occurence using a modal including GADD34 RNA increase, SLEDAI score and Physician Global Assessment (PGA). This modal is compared to the gold standard modal which use only PGA and SLEDAI Score in term of sensibility and specificity.

Time frame: Measured every 3 months, up to 1 year (5 blood samples).The Last result before a SLE flare occurence will be used.

Pro-inflammatory cytokine blood level.

Correlation between GADD34 RNA increase or decrease and interferon-alpha, interferon-beta, interleukin-6 and interleukine-17 levels.

Time frame: Measured every 3 months, up to 1 year (5 blood samples).

Data from ClinicalTrials.gov

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