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NCT Number: NCT01804647

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

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).

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Key information

Conditions

Multiple Sclerosis (MS) Autoimmune Diseases Autoimmune Diseases of the Nervous System Clinically Isolated Syndrome (CIS) Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases Primary Progressive MS Relapsing-Remitting MS Secondary Progressive MS

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices civils de Lyon - Service de Neurologie A - 59 Boulevard Pinel, Bron, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

No study treatments administered - blood draws only

Other

Primary outcomes

  1. Monitor the levels of MSRV-Env expression in MS patients (according to McDonald criteria) of different diagnostic subgroups (RRMS, SPMS, PPMS, CIS)

    Time frame: 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 outcomes

  1. Associate the levels of MSRV-Env protein and transcripts

    Time frame: 1 year

  2. 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

    Time frame: 1 year

  3. Associate the levels of MSRV-Env as assessed with the 3 approaches with levels of inflammatory markers and reverse transcriptase activity

    Time frame: 1 year

  4. Compare levels of MSRV-Env of MS patients to those obtained in a parallel study in Healthy Controls

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

GeNeuro Innovation SAS

Industry

Registry information

Official study 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

Acronym: LOMBARD

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 5, 2013
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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