NCT02142764

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

December 7, 2016

Status Verified

December 1, 2016

Enrollment Period

1.3 years

First QC Date

May 15, 2014

Last Update Submit

December 6, 2016

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisCD8+ T-cellsClass I Major Histocompatibility Complex (MHC)pentamers

Outcome Measures

Primary Outcomes (1)

  • Analysis of pentamers (> 0,1 % of the CD3 + CD8 + T-cells) will be statistically compared between the 3 groups of patients.

    This analysis will enable us to detect CD8+ myelin specific T-cells in the blood of Multiple Sclerosis

    6 months after the inclusion

Secondary Outcomes (3)

  • The results will be correlated with the patients clinical

    6 months after the inclusion

  • The results will be correlated with the patients MRI data

    6 months after the inclusion

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

    6 months after the inclusion

Study Arms (3)

Multiple Sclerosis

EXPERIMENTAL

Human Leukocyte Antigen (HLA)-A2 patients whose Multiple Sclerosis has just been diagnosed

Biological: Blood samples

Control

OTHER

HLA-A2 patients hospitalized in the neurology department who are not affected with a neuroimmunological disorder

Biological: Blood samples

Multiple Sclerosis patients treated

EXPERIMENTAL

HLA-A2 Multiple Sclerosis patients treated by Natalizumab therapy

Biological: Blood samples

Interventions

Blood samplesBIOLOGICAL

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).

Multiple SclerosisMultiple Sclerosis patients treated

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Group 1: HLA-A2 patients whose Multiple Sclerosis has just been diagnosed
  • 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
  • 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
  • year old and older patients,
  • +4 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Neurologie - Tripode - Hôpital Pellegrin

Bordeaux, Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jean-Christophe OUALLET, MD

    University Hospital Bordeaux, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2014

First Posted

May 20, 2014

Study Start

November 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

December 7, 2016

Record last verified: 2016-12

Locations

FR(1)