Skip to main content
OpenTrials
Completed

NCT Number: NCT03206359

GADD34 and Type I IFN Response Genes in SLE

GADD34 (Growth Arrest and DNA Damage inducible-protein) is a regulatory subunit of PP1 (phosphatase 1) phosphatase which dephosphorylates eIF2alpha (eucaryotic initiation factor 2 alpha subunit), representing a negative feedback loop of the unfolded protein response (UPR). Moreover, GADD34 is necessary for type I interferon (IFN) production in response to viral infection in murine models. We investigate here the expression of GADD34 in systemic lupus erythematosus (SLE), in which type I IFN has an important pathogenic role.

We report a case-control study on GADD34 gene expression in PBMC (peripheral blood mononuclear cells) of SLE patients (n=60) and age- and sex-matched healthy controls (n=30). The level of GADD34 gene expression, as well as of type-I IFN response genes in PBMC is measured by quantitative PCR.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Man and woman over 18 years old.
  • Patients suffering from SLE (SLICC criteria)
  • Patients having given their "Non-opposition"
  • Patients with social security affiliation (required in France)

Exclusion criteria

  • Patients suffering from other auto-immune disease (except SAPL, thyroiditis, and Gougerot Sjogren syndrome)
  • Patients with viral infection within 15 days
  • People with special protection (defined in articles L1121-§5-8 and articles L3212-§1-3 of French health care law)

Treatment and study plan

Primary outcomes

  1. GADD34 expression in SLE patients

    Time frame: 4 years

    Evaluation of GADD34 expression in PBMC of patients suffering from SLE compared to GADD34 expression in PBMC of healthy subjets. GADD34 gene expression level is quantified in the PBMC by quantitative PCR

Secondary outcomes

  1. GADD34 and IFN response gene expression

    Time frame: 4 years

    Evaluation of the relation between IFN response gene expression and GADD34 expression in PBMC of patients suffering from SLE. IFN response gene and GADD34 expression level is quantified in the PBMC by quantitative PCR

  2. GADD34 expression and pathology activity

    Time frame: 4 years

    Evaluation of the relation between GADD34 overexpression and the activity of the pathology

  3. GADD34 expression and pathology activity

    Time frame: 4 years

    Evaluation of the relation between GADD34 overexpression and the presence of anti-DNA antibodies.

  4. CHOP and BiP expression

    Time frame: 4 years

    Evaluation of the expression of other genes of UPR (like CHOP and BiP) in PBMC of patients with SLE, compared to the expression of these genes in PBMC of healthy subjets.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Evaluation of GADD34 and Type I IFN Response Gene Expression in Patients Suffering From Systemic Lupus Erythematosus

Acronym: GADD34-IFN

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 2, 2017
Registry last updated
Jul 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.