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

Sponsor

GeNeuro Innovation SAS (Industry)

Overall Status

Completed

CT.gov ID

NCT01804647

Collaborator

(none)

Enrollment

Locations

Duration (Months)

14.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis (MS) Relapsing-Remitting MS Primary Progressive MS Secondary Progressive MS Clinically Isolated Syndrome (CIS)	Other: No study treatments administered - blood draws only

Study Design

Study Type:

Observational

Actual Enrollment :

58 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

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