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

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ClinicalTrials.gov Identifier: NCT02142764
Recruitment Status : Completed
First Posted : May 20, 2014
Last Update Posted : December 7, 2016
Sponsor:
Collaborators:
Merck Serono International SA
ADERA
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Biological: Blood samples Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Preliminary Study for Selective Detection of the CD8+ Myelin Specific T Cell in the Blood of Multiple Sclerosis Patients (MS).
Study Start Date : November 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


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).

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, 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).




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02142764


Locations
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France
Service de Neurologie - Tripode - Hôpital Pellegrin
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
Merck Serono International SA
ADERA
Investigators
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Principal Investigator: Jean-Christophe OUALLET, MD University Hospital Bordeaux, France

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02142764     History of Changes
Other Study ID Numbers: CHUBX 2013/01
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016

Keywords provided by University Hospital, Bordeaux:
Multiple Sclerosis
CD8+ T-cells
Class I Major Histocompatibility Complex (MHC)
pentamers

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases