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

A One Year Longitudinal Therapeutically Non-Interventional Study of MSRV-Env Burden in Multiple Sclerosis Patients (RRMS - SPMS - PPMS - CIS) as Assessed by PCR and ELISA in Blood

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 Overview

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

• Study Type: Observational
• Enrollment (Actual): 58

Contacts and Locations

Study Locations

• France
  • Bron cedex, France, 69677
    • Hospices civils de Lyon - Service de Neurologie A - 59 Boulevard Pinel
  • Marseille Cedex 5, France, 13385
    • CHU Timone - Service de Neurologie et CRMBM CNRS 7339 - 264, rue Saint Pierre
• Spain
  • Cataluna
    • Barcelona, Cataluna, Spain, 08035
      • Hospital Universitari and Research Institute Vall d'Hebron - Servicio de Neuroimunologia de Nuestro Centro - Pg. Vall d'Hebron 119-129
• Switzerland
  • Lausanne, Switzerland, CH-1011
    • Centre Hospitalier Universitaire Vaudois - Dpt of Clinical Neurosciences - Neurology /Batiment 10-131 - Rue du Bugnon 46 -

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients coming to the Hospital for regular visits.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: GeNeuro Innovation SAS

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: March 4, 2013
• First Submitted That Met QC Criteria: March 4, 2013
• First Posted (Estimate): March 5, 2013

Study Record Updates

• Last Update Posted (Actual): October 20, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Multiple sclerosis (MS); Relapsing-Remitting MS; Temelimab; Clinically Isolated Syndrome (CIS); Primary progressive MS; Secondary progressive MS; Multiple Sclerosis associated RetroVirus (MSRV); MSRV envelop protein (MSRV-Env)
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: GN-E-002