Skip to main content
OpenTrials
Completed

NCT Number: NCT02142764

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Neurologie - Tripode - Hôpital Pellegrin

Bordeaux, 33076, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood samples

Biological

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).

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Description of lymphocyte immunophenotyping and dosage of immunoglobulins in patients treated with Natalizumab

    Time frame: 6 months after the inclusion

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • ADERA
  • Merck Serono International SA

Registry information

Official study title

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

Acronym: IMMUNOSEP

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 20, 2014
Registry last updated
Dec 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.