|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT01081184 |
|
Date of registration:
|
03/03/2010 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Neurotrophins Implications in Primary Sjögren Syndrome
Neuro-SGSp |
|
Scientific title:
|
Neurotrophins Implications in Primary Sjögren Syndrome |
|
Date of first enrolment:
|
March 2010 |
|
Target sample size:
|
40 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01081184 |
|
Study type:
|
Observational |
|
Study design:
|
Observational Model: Case Control, Time Perspective: Prospective
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Anne-Laure FAUCHAIS, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Limoges UH |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Primary Sjögren Syndrome
|
|
Intervention(s)
|
|
Biological: blood sample
|
|
Primary Outcome(s)
|
|
Lymphocytic levels of NTs (i.e. NGF, BDNF and NT-3)
[Time Frame: 1 day]
|
|
Secondary Outcome(s)
|
|
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]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|