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

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Biological: Blood samples

• Registration Number: NCT02142764
• Lead Sponsor: University Hospital, Bordeaux

Brief 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.

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.

Study Timeline

• Study First Submitted: 2014-05-15
• Study First Submitted QC: 2014-05-19
• Study First Posted: 2014-05-20
• Study Start: 2014-11
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-06
• Last Update Posted: 2016-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple Sclerosis patients treated	Blood samples	HLA-A2 Multiple Sclerosis patients treated by Natalizumab therapy
Multiple Sclerosis	Blood samples	Human Leukocyte Antigen (HLA)-A2 patients whose Multiple Sclerosis has just been diagnosed
Control	Blood samples	HLA-A2 patients hospitalized in the neurology department who are not affected with a neuroimmunological disorder

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Service de Neurologie - Tripode - Hôpital Pellegrin; 🇫🇷 Bordeaux, France