Clinical trial NCT01804647: Longitudinal Therapeutically Non-interventional Study of MSRV-Env Burden in Patients With Multiple Sclerosis Disease
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 type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: GeNeuro SA
Sponsor class: INDUSTRY
First posted: 2013-03-05
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients coming to the Hospital for regular visits.

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).


Eligibility criteria: 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).

Primary outcomes:
measure: Monitor the levels of MSRV-Env expression in MS patients (according to McDonald criteria) of different diagnostic subgroups (RRMS, SPMS, PPMS, CIS)
timeFrame: 1 year
Secondary outcomes:
measure: Associate the levels of MSRV-Env protein and transcripts
timeFrame: 1 year
measure: 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
timeFrame: 1 year
measure: Associate the levels of MSRV-Env as assessed with the 3 approaches with levels of inflammatory markers and reverse transcriptase activity
timeFrame: 1 year
measure: Compare levels of MSRV-Env of MS patients to those obtained in a parallel study in Healthy Controls
timeFrame: 1 year
Other outcomes:
Locations:
city: Bron cedex
country: France
facility: Hospices civils de Lyon - Service de Neurologie A - 59 Boulevard Pinel
city: Marseille Cedex 5
country: France
facility: CHU Timone - Service de Neurologie et CRMBM CNRS 7339 - 264, rue Saint Pierre
city: Barcelona
country: Spain
facility: Hospital Universitari and Research Institute Vall d'Hebron - Servicio de Neuroimunologia de Nuestro Centro - Pg. Vall d'Hebron 119-129
state: Cataluna
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois - Dpt of Clinical Neurosciences - Neurology /Batiment 10-131 - Rue du Bugnon 46 -
Study officials:
References: