Longitudinal Therapeutically Non-interventional Study of MSRV-Env Burden in Patients With Multiple Sclerosis Disease

GeNeuro Innovation SAS58 enrolled

Overview

This study intends to explore evolution of MSRV expression by analyzing the levels of MSRV transcripts in blood, as well as the levels of the MSRV-Env protein in serum of MS patients. The study will be conducted over one year in four cohorts of patients with different forms of MS (remitting-relapsing MS i.e. RRMS, primary-progressive MS i.e. PPMS and secondary-progressive MS i.e. SPMS) and in clinically isolated syndrome (CIS) patients who have suffered a single clinical event but do not comply with diagnosis criteria for definite MS. The MSRV RNA and MSRV-Env protein levels will be correlated with the clinical evolution of patients and with the reverse transcriptase activity, inflammatory markers assessed by cytokines levels. A control group of healthy subjects will be included (the study, GN-E-003, is performed in parallel and is part of another dedicated protocol).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Multiple Sclerosis (MS)Relapsing-Remitting MS Primary Progressive MS Secondary Progressive MS Clinically Isolated Syndrome (CIS)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signature of an informed consent; * Male or female between 18 and 60 years of age; * Patients with PPMS (Revised McDonald criteria 2010) or patients with SPMS or CIS or patients with RRMS (Revised McDonald criteria 2010) ideally without IFN beta therapy at the T0 visit for RRMS patient only. Exclusion Criteria: * Positive serology for hepatitis B or C or HIV; * Acute infection at inclusion; * Severe psychiatric disorder; * Autoimmune disease other than MS; * Pregnancy or breastfeeding; * Heavy smokers i.e. more than 10 cigarettes per day; * History of alcohol or drug abuse in the last 3 years; * Participation in a clinical trial (within the last 3 months).

Locations (4)

Hospices civils de Lyon - Service de Neurologie A - 59 Boulevard Pinel

Bron, France

CHU Timone - Service de Neurologie et CRMBM CNRS 7339 - 264, rue Saint Pierre

Marseille, France

Hospital Universitari and Research Institute Vall d'Hebron - Servicio de Neuroimunologia de Nuestro Centro - Pg. Vall d'Hebron 119-129

Barcelona, Catalonia, Spain

Centre Hospitalier Universitaire Vaudois - Dpt of Clinical Neurosciences - Neurology /Batiment 10-131 - Rue du Bugnon 46 -

Lausanne, Switzerland

Outcomes

Primary Outcomes

Monitor the levels of MSRV-Env expression in MS patients (according to McDonald criteria) of different diagnostic subgroups (RRMS, SPMS, PPMS, CIS)

Monitor the levels of MSRV-Env expression in MS patients (according to McDonald criteria) of different diagnostic subgroups (RRMS, SPMS, PPMS, CIS) over time using 3 approaches: * MSRV transcripts in PBMC; * MSRV transcripts in plasma; * MSRV-Env protein in serum.

Time frame: 1 year

Secondary Outcomes

Associate the levels of MSRV-Env protein and transcripts

Time frame: 1 year

Associate the levels of MSRV-Env as assessed with the 3 approaches with MS relapses/exacerbations and/or clinical evolution (EDSS score) and /or treatment

Time frame: 1 year

Associate the levels of MSRV-Env as assessed with the 3 approaches with levels of inflammatory markers and reverse transcriptase activity

Time frame: 1 year

Compare levels of MSRV-Env of MS patients to those obtained in a parallel study in Healthy Controls

Time frame: 1 year

Longitudinal Therapeutically Non-interventional Study of MSRV-Env Burden in Patients With Multiple Sclerosis Disease

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes