Neurotrophins Implications in Primary Sjögren Syndrome (Neuro-SGSp)

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.

Study Overview

• Status: Completed
• Conditions: Primary Sjögren Syndrome
• Intervention / Treatment: Biological: blood sample

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87142
    • Médecine interne
  • Limoges, France, 87142
    • Opthalmologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People with primary Sjögren syndrome

People free of disease : healthy volunteers

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy volunteers	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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lymphocytic levels of NTs (i.e. NGF, BDNF and NT-3)	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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Investigators: Principal Investigator: Anne-Laure FAUCHAIS, MD, Limoges UH

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: March 3, 2010
• First Submitted That Met QC Criteria: March 4, 2010
• First Posted (Estimate): March 5, 2010

Study Record Updates

• Last Update Posted (Estimate): April 17, 2013
• Last Update Submitted That Met QC Criteria: April 16, 2013
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: T cell; B cell; primary Sjögren syndrome; neurotrophins; sicca syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Sjogren's Syndrome
• Other Study ID Numbers: I08010