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OpenTrials
Completed

NCT Number: NCT01081184

Neurotrophins Implications in Primary Sjögren Syndrome

Neurotrophins (NTs) constitute a family of growth factors, which regulated differentiation, proliferation, and survival of both neuronal cells and astrocytes. In recent years, several studies have provided evidences that the cellular effects of NGF " Nerve Growth Factor ", BDNF " Brain-Derived Neurotrophic Factor " and NT-3 are not limited to the nervous system. Indeed, neurotrophins and their receptors are widely expressed on non neuronal cells. Data concerning the implication of NTs and their receptors in the immune system maturation and in the regulation of normal and pathological immune responses are numerous and suggest the existence of a specific "neuro-immunomodulation" through these neuropeptides.

The aim of the study is to compare Sjögren's syndrome systemic activity to seric, lymphocytic and conjunctival levels of NTs (i.e NGF, BDNF and NT-3). A preliminary study has previously pointed out the link between high BDNF seric levels and Sjögren's systemic activity. The increased levels of BDNF were correlated to T cell activation. A similar correlation between high NGF level and hypergammaglobulinemia was also pointed out.

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Key information

About this study

2 supplementary blood sample for determination of seric and lymphocytic NT profile will be added to a standard biological analysis done for pSS follow- up.

Salivary sicca syndrome will be evaluated with un-stimulated salivary flow rate. Saliva fluid will be collected from NTs levels determination (ELISA). Ocular sicca syndrome will be evaluated by Schirmer tests and Lissaline green test. A conjunctival cytological impression will be done in order to determine NTs conjunctival production by flow cytometry.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Arm : primary Sjögren syndrome:

  • All patients must fulfill the revised criteria for primary Sjögren syndrome.
  • Age of entry into the study ≥ 18 yrs.
  • Affiliated or profit patient of a social security system.
  • Informed consent signed up.

Arm : healthy volunteers:

  • All patient free of autoimmune disease.
  • Age of entry into the study ≥ 18 yrs.
  • Affiliated or profit patient of a social security system.
  • Informed consent signed up.

Exclusion criteria

  • Patient with psychiatric disorders not related with antiphospholipid syndrome and / or cerebral complication of SGSp.
  • Addictive behaviors (alcoholism, cocaine or opioid abuse).
  • Patient with anti-depressive drugs.
  • Patient with concurrent malignancy
  • Pregnancy
  • Patients under measure of maintenance of justice.
  • Patients unable to understand or to participate to the study.
  • Child and major patients making the object of a measure of lawful protection.
  • Patients deprived of freedom.

Exclusion criteria

for control group

  • Autoimmune disease.
  • Steroid treatment (>20 mg/day).
  • Immunosuppressive treatment.
  • Concurrent malignancy.
  • Concurrent psychiatric disorders.
  • Anti-depressive drugs.
  • Pregnancy.

Treatment and study plan

Blood sample

Biological

blood sample for determination of seric and lymphocytic NT profile will be added to a standard biological analysis done for pSS follow- up

Other names: Salivary sicca syndrome will be evaluated., Saliva fluid will be collected., Ocular sicca syndrome will be evaluated., A conjonctival cytological impression will be done.

Primary outcomes

  1. Lymphocytic levels of NTs (i.e. NGF, BDNF and NT-3)

    Time frame: 1 day

    2 supplementary blood sample for determination of seric and lymphocytic NT profile will be added to a standard biological analysis done for pSS follow- up.

Secondary outcomes

  1. Disease activity score used: ESSDAI; NGF, BDNF and NT3 levels in sera; pSS immunological profile; intensity of sicca syndrome; salivary levels of NTs; conjunctival expression of NTs.

    Time frame: 1 day

    Salivary sicca syndrome will be evaluated with un-stimulated salivary flow rate. Saliva fluid will be collected from NTs levels determination (ELISA). Ocular sicca syndrome will be evaluated by Schirmer tests and Lissaline green test. A conjunctival cytological impression will be done in order to determine NTs conjonctival production by flow cytometry.

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: Neuro-SGSp

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Mar 5, 2010
Registry last updated
Apr 17, 2013

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.

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