Multiple Sclerosis (MS)LOMBARDNCT01804647
Longitudinal Therapeutically Non-interventional Study of MSRV-Env Burden in Patients With Multiple Sclerosis Disease
An observational study of Multiple Sclerosis (MS) and Relapsing-Remitting MS, run by GeNeuro Innovation SAS at 4 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis (MS), Relapsing-Remitting MS, Primary Progressive MS
- What is being tested?
- No study treatments administered - blood draws only
- How many people
- 58 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Nov 2012to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients coming to the Hospital for regular visits.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
France2 sites
Hospices civils de Lyon - Service de Neurologie A - 59 Boulevard Pinel
Bron, 69677
CHU Timone - Service de Neurologie et CRMBM CNRS 7339 - 264, rue Saint Pierre
Marseille, 13385
Spain1 site
Hospital Universitari and Research Institute Vall d'Hebron - Servicio de Neuroimunologia de Nuestro Centro - Pg. Vall d'Hebron 119-129
Barcelona, Catalonia, 08035
Switzerland1 site
Centre Hospitalier Universitaire Vaudois - Dpt of Clinical Neurosciences - Neurology /Batiment 10-131 - Rue du Bugnon 46 -
Lausanne, CH-1011
About this study
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
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).
- Conditions
- Multiple Sclerosis (MS), Relapsing-Remitting MS, Primary Progressive MS, Secondary Progressive MS, Clinically Isolated Syndrome (CIS)
- Being tested
- No study treatments administered - blood draws only
- 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
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No study treatments administered - blood draws onlyOther
| Study group | Role | What they receive |
|---|---|---|
| 33 RRMS patients | No study treatments administered Receives: Other: No study treatments administered - blood draws only | |
| 9 PPMS patients | No study treatments administered Receives: Other: No study treatments administered - blood draws only | |
| 12 SPMS patients | No study treatments administered Receives: Other: No study treatments administered - blood draws only | |
| 4 CIS patients | No study treatments administered Receives: Other: No study treatments administered - blood draws only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (4)
Associate the levels of MSRV-Env protein and transcripts
Measured: 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
Measured: 1 year
Associate the levels of MSRV-Env as assessed with the 3 approaches with levels of inflammatory markers and reverse transcriptase activity
Measured: 1 year
Compare levels of MSRV-Env of MS patients to those obtained in a parallel study in Healthy Controls
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startNov 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- GeNeuro Innovation SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804647
- Sponsor's protocol ID
- GN-E-002
- Acronym
- LOMBARD
- Status last verified
- Feb 2018
- First submitted
- 4 Mar 2013
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01804647
- Acronym / sponsor ID
- LOMBARD / GN-E-002
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- GeNeuro Innovation SASIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 5 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 33 RRMS patients | – | Other: No study treatments administered - blood draws onlyNo study treatments administered |
| 9 PPMS patients | – | Other: No study treatments administered - blood draws onlyNo study treatments administered |
| 12 SPMS patients | – | Other: No study treatments administered - blood draws onlyNo study treatments administered |
| 4 CIS patients | – | Other: No study treatments administered - blood draws onlyNo study treatments administered |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients coming to the Hospital for regular visits.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- Positive serology for hepatitis B or C or HIV;
- Acute infection at inclusion;
- Severe psychiatric disorder;
- Autoimmune disease other than MS;
- Pregnancy or breastfeeding;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No study treatments administered - blood draws only | Other | 12 SPMS patients, 33 RRMS patients, 4 CIS patients, 9 PPMS patients |
Primary outcome
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.
4 secondary outcomes
Associate the levels of MSRV-Env protein and transcripts
Time frame: 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
Time frame: 1 year
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
Compare levels of MSRV-Env of MS patients to those obtained in a parallel study in Healthy Controls
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis (MS) and Relapsing-Remitting MS, run by GeNeuro Innovation SAS at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Spain, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020; AzTrials last refreshed its copy on 26 Oct 2026.