Clinical trial NCT01081184: Neurotrophins Implications in Primary Sjögren Syndrome
Official title: Neurotrophins Implications in Primary Sjögren Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Sjögren Syndrome
Keywords: primary Sjögren syndrome
neurotrophins
B cell
sicca syndrome
T cell
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2010-03-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with primary Sjögren syndrome

People free of disease : healthy volunteers

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lymphocytic levels of NTs (i.e. NGF, BDNF and NT-3)
timeFrame: 1 day
Secondary outcomes:
measure: 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.
timeFrame: 1 day
Other outcomes:
Locations:
city: Limoges
country: France
facility: Médecine Interne
city: Limoges
country: France
facility: Opthalmologie
Study officials:
affiliation: Limoges UH
name: Anne-Laure FAUCHAIS, MD
role: PRINCIPAL_INVESTIGATOR
References: