Neurotrophins Implications in Primary Sjögren Syndrome

NCT01081184 | Completed

• 1 other identifier: I08010
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Primary Sjögren Syndrome

Keywords

primary Sjögren syndrome; neurotrophins; B cell; sicca syndrome; T cell

Outcome Measures

Primary Outcomes (1)

• 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 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.

  1 day

Study Arms (2)

primary Sjögren syndrome

Biological: blood sample

Healthy volunteers

Biological: blood sample

Interventions

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

Also known as: Salivary sicca syndrome will be evaluated., Saliva fluid will be collected., Ocular sicca syndrome will be evaluated., A conjonctival cytological impression will be done.

Healthy volunteers; primary Sjögren syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with primary Sjögren syndrome People free of disease : healthy volunteers

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (2)

Médecine Interne

Limoges, 87142, France

Location

Opthalmologie

Limoges, 87142, France

Location

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Anne-Laure FAUCHAIS, MD

  Limoges UH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2010
• First Posted: March 5, 2010
• Study Start: March 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2012
• Last Updated: April 17, 2013

Record last verified: 2010-03

Locations

FR (2)