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

December 6, 2016 updated by: University Hospital, Bordeaux

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Service de Neurologie - Tripode - Hôpital Pellegrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multiple Sclerosis
Human Leukocyte Antigen (HLA)-A2 patients whose Multiple Sclerosis has just been diagnosed
Biological: 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).
Biological: Blood samples
The blood will be sampled in order to be tested in Immunology, once, the day they sign their agreement (at the inclusion)
Other: Control
HLA-A2 patients hospitalized in the neurology department who are not affected with a neuroimmunological disorder
Biological: 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).
Biological: Blood samples
The blood will be sampled in order to be tested in Immunology, once, the day they sign their agreement (at the inclusion)
Experimental: Multiple Sclerosis patients treated
HLA-A2 Multiple Sclerosis patients treated by Natalizumab therapy
Biological: 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).
Biological: Blood samples
The blood will be sampled in order to be tested in Immunology, once, the day they sign their agreement (at the inclusion)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 6 months after the inclusion
This analysis will enable us to detect CD8+ myelin specific T-cells in the blood of Multiple Sclerosis
6 months after the inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The results will be correlated with the patients clinical
Time Frame: 6 months after the inclusion
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
Time Frame: 6 months after 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
Time Frame: 6 months after the inclusion
6 months after the inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

Merck Serono International SA
ADERA

Investigators

  • Principal Investigator: Jean-Christophe OUALLET, MD, University Hospital Bordeaux, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

May 15, 2014

First Submitted That Met QC Criteria

May 19, 2014

First Posted (Estimate)

May 20, 2014

Study Record Updates

Last Update Posted (Estimate)

December 7, 2016

Last Update Submitted That Met QC Criteria

December 6, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2013/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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