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| Name | Class |
|---|---|
| Merck Serono International SA | INDUSTRY |
| ADERA | UNKNOWN |
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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.
30 patients distributed in 3 groups of 10 patients with specific inclusion criteria will participate in this trial:
The aim of this clinical trial is to detect the CD8+ myelin specific T-Cells in the blood of Multiple Sclerosis patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiple Sclerosis | Experimental | Human Leukocyte Antigen (HLA)-A2 patients whose Multiple Sclerosis has just been diagnosed |
|
| Control | Other | HLA-A2 patients hospitalized in the neurology department who are not affected with a neuroimmunological disorder |
|
| Multiple Sclerosis patients treated | Experimental | HLA-A2 Multiple Sclerosis patients treated by Natalizumab therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples | Biological | 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Group 1: HLA-A2 patients whose Multiple Sclerosis has just been diagnosed
Group 2: HLA-A2 patients hospitalized in the neurology department who are not affected with a neuroimmunological disorder
Group 3: HLA-A2 Multiple Sclerosis patients treated by Natalizumab therapy
Exclusion Criteria:
Group 1 and 3:
Group 2:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Christophe OUALLET, MD | University Hospital Bordeaux, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Neurologie - Tripode - Hôpital Pellegrin | Bordeaux | Bordeaux | 33076 | France |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Blood samples | Biological | The blood will be sampled in order to be tested in Immunology, once, the day they sign their agreement (at the inclusion) |
|
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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |