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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 clinical

The 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

Page last updated: August 23, 2015

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