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

Multiple Sclerosis Clinical Trial

— IMMUNOSEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02142764
• Other study ID #: CHUBX 2013/01
• Status: Completed
• Phase: N/A
• First received: May 15, 2014
• Last updated: December 6, 2016
• Start date: November 2014
• Est. completion date: February 2016

Study information

• Verified date: December 2016
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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).
• Blood samples
The blood will be sampled in order to be tested in Immunology, once, the day they sign their agreement (at the inclusion)

Locations

Country	Name	City	State
France	Service de Neurologie - Tripode - Hôpital Pellegrin	Bordeaux

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	ADERA, Merck Serono International SA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The results will be correlated with the patients clinical	Number of attacks relapses and evolution of the Expanded Disability Status Scale from the last 2 years	6 months after the inclusion	No
Secondary	The results will be correlated with the patients MRI data	MRI activity (load lesions (= 9 lesions or not), gadolinium enhanced) from the last 2 years	6 months after the inclusion	No
Secondary	Description of lymphocyte immunophenotyping and dosage of immunoglobulins in patients treated with Natalizumab		6 months after the inclusion	No