Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, CD8+ T-cells, Class I Major Histocompatibility Complex (MHC), pentamers
Brief summary
Most experts in the field consider Multiple Sclerosis as the main auto immune disease of the central nervous system. In spite of many works, the data in the literature concerning the antigens targeted by the CD8+ T-Cell response are still contradictory and insufficient.
Detailed description
30 patients distributed in 3 groups of 10 patients with specific inclusion criteria will participate in this trial: * 10 MS patients in early disease onset, * 10 MS patients under Natalizumab treatment * and control group of 10 patients with other neurological diseases. The aim of this clinical trial is to detect the CD8+ myelin specific T-Cells in the blood of Multiple Sclerosis patients.
Interventions
BIOLOGICALBlood samples
The blood will be sampled in order to be tested in Immunology, twice, the day they sign their agreement and six months after in case of positive myelin pentamer test (at inclusion and 6 months after the inclusion).
Sponsors
Merck Serono International SA
ADERA
University Hospital, Bordeaux
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Group 1: HLA-A2 patients whose Multiple Sclerosis has just been diagnosed * 18 year old and older patients, * HLA-A2 Patients with Multiple Sclerosis or clinically isolated syndrome at high risk of being affected by Multiple Sclerosis (criteria of spatial scattering according to the 2010 or 2005 McDonald's criteria) * Patients without treatment or treated with immunomodulating therapy * Patients affiliated to health insurance coverage * Information and comprehensive agreement signed by the patient and the investigator Group 2: HLA-A2 patients hospitalized in the neurology department who are not affected with a neuroimmunological disorder * 18 year old and older patients, * HLA-A2 patients hospitalized in the neurology department * Patient not affected by Multiple Sclerosis or a related inflammatory disorder * Affiliated or profitable subject of a national insurance scheme * Patients affiliated to health insurance coverage * Information and comprehensive agreement signed by the patient and the investigator Group 3: HLA-A2 Multiple Sclerosis patients treated by Natalizumab therapy * 18 year old and older patients, * HLA-A2 patients with relapsing remitting (RR) MS fulfilling McDonald 2005 or 2010 Multiple Sclerosis diagnostic criteria * Patients treated by Natalizumab therapy for at least 3 months * Patients affiliated to health insurance coverage * Information and comprehensive agreement signed by the patient and the investigator
Exclusion criteria
Group 1 and 3: * Patients undergoing immunosuppressive therapy at present or in the past except Natalizumab * Pregnant women Group 2: * Patients undergoing immunosuppressive therapy at present or in the past * Patients affected by Multiple Sclerosis or a related disorder * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of pentamers (> 0,1 % of the CD3 + CD8 + T-cells) will be statistically compared between the 3 groups of patients. | 6 months after the inclusion | This analysis will enable us to detect CD8+ myelin specific T-cells in the blood of Multiple Sclerosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The results will be correlated with the patients clinical | 6 months after the inclusion | Number of attacks relapses and evolution of the Expanded Disability Status Scale from the last 2 years |
| The results will be correlated with the patients MRI data | 6 months after the inclusion | MRI activity (load lesions (≥ 9 lesions or not), gadolinium enhanced) from the last 2 years |
| Description of lymphocyte immunophenotyping and dosage of immunoglobulins in patients treated with Natalizumab | 6 months after the inclusion | — |
Countries
France
Outcome results
None listed