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

Multiple Sclerosis (MS) Clinical Trial

— LOMBARD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01804647
• Other study ID #: GN-E-002
• Status: Completed
• Start date: November 2012
• Est. completion date: February 2015

Study information

• Verified date: February 2018
• Source: GeNeuro SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Other:
• No study treatments administered - blood draws only

Locations

Country	Name	City	State
France	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
Spain	Hospital Universitari and Research Institute Vall d'Hebron - Servicio de Neuroimunologia de Nuestro Centro - Pg. Vall d'Hebron 119-129	Barcelona	Cataluna
Switzerland	Centre Hospitalier Universitaire Vaudois - Dpt of Clinical Neurosciences - Neurology /Batiment 10-131 - Rue du Bugnon 46 -	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
GeNeuro Innovation SAS

Countries where clinical trial is conducted

France,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Associate the levels of MSRV-Env protein and transcripts		1 year
Secondary	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
Secondary	Associate the levels of MSRV-Env as assessed with the 3 approaches with levels of inflammatory markers and reverse transcriptase activity		1 year
Secondary	Compare levels of MSRV-Env of MS patients to those obtained in a parallel study in Healthy Controls		1 year