Preliminary Study for Selective Detection of the CD8+ Myelin Specific T Cell in the Blood of Multiple Sclerosis Patients
NCT ID: NCT02142764
Last Updated: 2016-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2014-11-30
2016-02-29
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
NONE
Study Groups
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Multiple Sclerosis
Human Leukocyte Antigen (HLA)-A2 patients whose Multiple Sclerosis has just been diagnosed
Blood 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).
Control
HLA-A2 patients hospitalized in the neurology department who are not affected with a neuroimmunological disorder
Blood samples
The blood will be sampled in order to be tested in Immunology, once, the day they sign their agreement (at the inclusion)
Multiple Sclerosis patients treated
HLA-A2 Multiple Sclerosis patients treated by Natalizumab therapy
Blood 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).
Interventions
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Blood 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).
Blood samples
The blood will be sampled in order to be tested in Immunology, once, the day they sign their agreement (at the inclusion)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Merck Serono International SA
INDUSTRY
ADERA
UNKNOWN
University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Jean-Christophe OUALLET, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Bordeaux, France
Locations
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Service de Neurologie - Tripode - Hôpital Pellegrin
Bordeaux, Bordeaux, France
Countries
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Other Identifiers
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CHUBX 2013/01
Identifier Type: -
Identifier Source: org_study_id