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Neurotrophins Implications in Primary Sjögren Syndrome (Neuro-SGSp)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01081184
First received: March 3, 2010
Last updated: April 16, 2013
Last verified: March 2010

March 3, 2010
April 16, 2013
March 2010
August 2011   (final data collection date for primary outcome measure)
Lymphocytic levels of NTs (i.e. NGF, BDNF and NT-3) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01081184 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Neurotrophins Implications in Primary Sjögren Syndrome
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

People with primary Sjögren syndrome

People free of disease : healthy volunteers

Primary Sjögren Syndrome
Biological: blood sample
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 Sjögren syndrome
    Intervention: Biological: blood sample
  • Healthy volunteers
    Intervention: Biological: blood sample
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
August 2012
August 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01081184
I08010
No
University Hospital, Limoges
University Hospital, Limoges
Not Provided
Principal Investigator: Anne-Laure FAUCHAIS, MD Limoges UH
University Hospital, Limoges
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP