Preliminary Study for Selective Detection of the CD8+ Myelin Specific T Cell in the Blood of Multiple Sclerosis Patients
Information source: University Hospital, Bordeaux
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis
Intervention: Blood samples (Biological); Blood samples (Biological)
Phase: N/A
Status: Active, not recruiting
Sponsored by: University Hospital, Bordeaux Official(s) and/or principal investigator(s): Jean-Christophe OUALLET, MD, Principal Investigator, Affiliation: University Hospital Bordeaux, France
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.
Clinical Details
Official title: Preliminary Study for Selective Detection of the CD8+ Myelin Specific T Cell in the Blood of Multiple Sclerosis Patients (MS).
Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: Analysis of pentamers (> 0,1 % of the CD3 + CD8 + T-cells) will be statistically compared between the 3 groups of patients.
Secondary outcome: The results will be correlated with the patients clinicalThe results will be correlated with the patients MRI data Description of lymphocyte immunophenotyping and dosage of immunoglobulins in patients treated with Natalizumab
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Service de Neurologie - Tripode - Hôpital Pellegrin, Bordeaux 33076, France
Additional Information
Starting date: November 2014
Last updated: July 22, 2015
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