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

Study Overview
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Brief Summary
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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).

Official Title
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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

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

Intervention / Treatment
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* Other: No study treatments administered - blood draws only


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 33 RRMS patients<br>No study treatments administered | Other: No study treatments administered - blood draws only<br> <br> |
| 9 PPMS patients<br>No study treatments administered | Other: No study treatments administered - blood draws only<br> <br> |
| 12 SPMS patients<br>No study treatments administered | Other: No study treatments administered - blood draws only<br> <br> |
| 4 CIS patients<br>No study treatments administered | Other: No study treatments administered - blood draws only<br> <br> |

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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