Preliminary Study for Selective Detection of the CD8+ Myelin Specific T Cell in the Blood of Multiple Sclerosis Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Preliminary Study for Selective Detection of the CD8+ Myelin Specific T Cell in the Blood of Multiple Sclerosis Patients (MS).

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Biological: Blood samples
* Biological: Blood samples


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multiple Sclerosis<br>Human Leukocyte Antigen (HLA)-A2 patients whose Multiple Sclerosis has just been diagnosed | Biological: Blood samples<br>* 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).<br>|
| Other: Control<br>HLA-A2 patients hospitalized in the neurology department who are not affected with a neuroimmunological disorder | Biological: Blood samples<br>* The blood will be sampled in order to be tested in Immunology, once, the day they sign their agreement (at the inclusion)<br>|
| Experimental: Multiple Sclerosis patients treated<br>HLA-A2 Multiple Sclerosis patients treated by Natalizumab therapy | Biological: Blood samples<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of pentamers (> 0,1 % of the CD3 + CD8 + T-cells) will be statistically compared between the 3 groups of patients. | This analysis will enable us to detect CD8+ myelin specific T-cells in the blood of Multiple Sclerosis | 6 months after the inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The results will be correlated with the patients clinical | Number of attacks relapses and evolution of the Expanded Disability Status Scale from the last 2 years | 6 months after the inclusion | 
| The results will be correlated with the patients MRI data | MRI activity (load lesions (≥ 9 lesions or not), gadolinium enhanced) from the last 2 years | 6 months after the inclusion | 
| Description of lymphocyte immunophenotyping and dosage of immunoglobulins in patients treated with Natalizumab |  | 6 months after the inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, CD8+ T-cells, Class I Major Histocompatibility Complex (MHC), pentamers