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

NCT01804647 | Completed

• 1 other identifier: GN-E-002
• Study Type: observational
• Target: 58
• Locations: 3 countries
• Sites: 4

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).

Conditions

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

Keywords

Multiple sclerosis (MS); Relapsing-Remitting MS; Primary progressive MS; Secondary progressive MS; Clinically Isolated Syndrome (CIS); Multiple Sclerosis associated RetroVirus (MSRV); MSRV envelop protein (MSRV-Env); Temelimab

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (4)

• Associate the levels of MSRV-Env protein and transcripts

  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

  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

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

  1 year

Study Arms (4)

33 RRMS patients

No study treatments administered

Other: No study treatments administered - blood draws only

9 PPMS patients

No study treatments administered

Other: No study treatments administered - blood draws only

12 SPMS patients

No study treatments administered

Other: No study treatments administered - blood draws only

4 CIS patients

No study treatments administered

Other: No study treatments administered - blood draws only

Interventions

No study treatments administered - blood draws only OTHER

12 SPMS patients; 33 RRMS patients; 4 CIS patients; 9 PPMS patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients coming to the Hospital for regular visits.

You may qualify if:

• 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.

You may not qualify if:

• Positive serology for hepatitis B or C or HIV;
• 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).

Sponsors & Collaborators

• GeNeuro Innovation SAS: lead

Study Sites (4)

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

Bron, 69677, France

Location

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

Marseille, 13385, France

Location

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

Barcelona, Catalonia, 08035, Spain

Location

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

Lausanne, CH-1011, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, serum and PBMC

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2013
• First Posted: March 5, 2013
• Study Start: November 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: October 20, 2020

Record last verified: 2018-02

Locations

FR (2); CH (1); ES (1)