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

Completed

• Conditions: Multiple Sclerosis (MS); Relapsing-Remitting MS; Primary Progressive MS; Secondary Progressive MS; Clinically Isolated Syndrome (CIS)
• Interventions: Other: No study treatments administered - blood draws only

• Registration Number: NCT01804647
• Lead Sponsor: GeNeuro Innovation SAS

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-03-04
• Study First Submitted QC: 2013-03-04
• Study First Posted: 2013-03-05
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2018-02
• Last Update Submitted: 2020-10-19
• Last Update Posted: 2020-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
12 SPMS patients	No study treatments administered - blood draws only	No study treatments administered
4 CIS patients	No study treatments administered - blood draws only	No study treatments administered
9 PPMS patients	No study treatments administered - blood draws only	No study treatments administered
33 RRMS patients	No study treatments administered - blood draws only	No study treatments administered

Primary Outcome Measures

Name	Time	Method
Monitor the levels of MSRV-Env expression in MS patients (according to McDonald criteria) of different diagnostic subgroups (RRMS, SPMS, PPMS, CIS)	1 year	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.

Secondary Outcome Measures

Name	Time	Method
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	1 year
Associate the levels of MSRV-Env protein and transcripts	1 year
Compare levels of MSRV-Env of MS patients to those obtained in a parallel study in Healthy Controls	1 year
Associate the levels of MSRV-Env as assessed with the 3 approaches with levels of inflammatory markers and reverse transcriptase activity	1 year

Trial Locations

Locations (4)

Hospices civils de Lyon - Service de Neurologie A - 59 Boulevard Pinel; 🇫🇷 Bron cedex, France

CHU Timone - Service de Neurologie et CRMBM CNRS 7339 - 264, rue Saint Pierre; 🇫🇷 Marseille Cedex 5, France

Hospital Universitari and Research Institute Vall d'Hebron - Servicio de Neuroimunologia de Nuestro Centro - Pg. Vall d'Hebron 119-129; 🇪🇸 Barcelona, Cataluna, Spain

Centre Hospitalier Universitaire Vaudois - Dpt of Clinical Neurosciences - Neurology /Batiment 10-131 - Rue du Bugnon 46 -; 🇨🇭 Lausanne, Switzerland