Multiple Sclerosis, Relapsing-RemittingSEP-MIRNCT05290688
Cellular microRNA Signatures in Multiple Sclerosis
A study testing 50 ml blodd sampling in people with Multiple Sclerosis, Relapsing-Remitting, run by Institut Pasteur at 1 site in France.
Trial summary
A limited number of studies on microRNA expression variation in immune cells have been reported in relapsing-remitting multiple sclerosis (RRMS). These studies have been performed mostly on a small scale and on whole blood mononuclear cells (PBMC). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- 50 ml blodd sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2022to 15 Sep 2024
- Phase
- Interventional
- 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
Who may be able to join
- Caucasian population
- Female and male individuals with an f/m ratio of 2-4/1
- Individuals with RRMS according to the 2010 McDonald criteria for less than 15 years, with EDSS 1-6, in remission or relapse
- Participant's condition compatible with a maximum of 50 ml of blood collection
- Persons affiliated with a social security plan.
Who cannot join
- MS treatment with steroidal anti-inflammatory drugs, immunomodulators or immunosuppressants within 2 months prior to blood collection
- Persons with acute and chronic infectious disease, autoimmune/inflammatory disease or cancer other than MS
- Pregnant or lactating women
- Be under guardianship,
- Be deprived of liberty by judicial or administrative decision, or be under legal protection.
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital La Pitié - Salpêtrière
Paris, 75013
Thomas Roux, MD, +33 1 42 16 17 51, thomas.roux@aphp.fr
About this study
A limited number of studies on microRNA expression variation in immune cells have been reported in relapsing-remitting multiple sclerosis (RRMS). These studies have been performed mostly on a small scale and on whole blood mononuclear cells (PBMC).
In a number of cases, RRMS progresses to a severe secondary neurodegenerative form. In this context, it is important to look for biomarkers that could indicate the pathogenic activity of certain immune cell subpopulations.
Read the detailed description
SEP-MIR is a prospective, single-center, descriptive study.
Participants will be recruited among adult patients with RRMS coming for a follow-up consultation in the Neurology Department, Nervous System Diseases Pole, at the hôpital Pitié - Salpêtrière (Paris).
As this is a descriptive study, the recruitment of 20 participants (10 patients with relapsing-remitting MS and 10 patients with relapsing-remitting MS) should meet the objectives of this study.
A 50 ml blood sample will be obtained from each participant and several clinical data regarding their pathology will be collected.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- 50 ml blodd sampling
- Keywords
- Inflammation, IFN-beta, Autoimmunity, Gene regulation
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Inflammation, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50 ml blodd samplingGenetic
50 ml blood sampling for genetic analysis (expression profiles of microRNAs)
| Study group | Role | What they receive |
|---|---|---|
| Untreated RRMS patients | Other | Untreated RRMS patients with a 50 ml blood sample during their routine care Receives: Genetic: 50 ml blodd sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
microRNA expression profiles in immune cell populations from RRMS patients
RNAseq and/or Nanostring sequencing of PBMCs from RRMS patients
Measured: 2 years
Secondary outcomes (2)
microRNA expression profiles in unstimulated and stimulated CD4+ T cell populations ex vivo from RRMS patients
RNAseq and/or Nanostring sequencing of unstimulated and stimulated CD4+ T cell populations ex vivo from RRMS patients
Measured: 2 years
microRNA expression profiles in monocytes from RRMS patients
RNAseq and/or Nanostring sequencing of monocytes from RRMS patients
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start15 Sep 2022 (estimated)
- Primary completion15 Sep 2024 (estimated)
- Study completion15 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 20 untreated RRMS patients divided into 2 groups: 10 RRMS in relapsing phase 10 RRMS in relapse.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere
- Responsible party
- Sponsor
- Investigators
- Frédérique Michel, PhD, Study director, Institut Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290688
- Sponsor's protocol ID
- 2021-044
- Other IDs
- 2021-A02983-3
- Acronym
- SEP-MIR
- Status last verified
- Aug 2022
- First submitted
- 11 Mar 2022
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cellular microRNA Signatures in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05290688
- Acronym / sponsor ID
- SEP-MIR / 2021-044
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Inflammation, IFN-beta, Autoimmunity, Gene regulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere
- Study start
- 15 Sep 2022 (estimated)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 15 Sep 2024 (estimated)
- First posted
- 22 Mar 2022 (actual)
- 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.
A limited number of studies on microRNA expression variation in immune cells have been reported in relapsing-remitting multiple sclerosis (RRMS). These studies have been performed mostly on a small scale and on whole blood mononuclear cells (PBMC).
In a number of cases, RRMS progresses to a severe secondary neurodegenerative form. In this context, it is important to look for biomarkers that could indicate the pathogenic activity of certain immune cell subpopulations.
Detailed description
SEP-MIR is a prospective, single-center, descriptive study.
Participants will be recruited among adult patients with RRMS coming for a follow-up consultation in the Neurology Department, Nervous System Diseases Pole, at the hôpital Pitié - Salpêtrière (Paris).
As this is a descriptive study, the recruitment of 20 participants (10 patients with relapsing-remitting MS and 10 patients with relapsing-remitting MS) should meet the objectives of this study.
A 50 ml blood sample will be obtained from each participant and several clinical data regarding their pathology will be collected.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 20 untreated RRMS patients divided into 2 groups: 10 RRMS in relapsing phase 10 RRMS in relapse.
| Arm | Type | Receives |
|---|---|---|
| Untreated RRMS patients | Other | Genetic: 50 ml blodd samplingUntreated RRMS patients with a 50 ml blood sample during their routine care |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Caucasian population
- Female and male individuals with an f/m ratio of 2-4/1
- Individuals with RRMS according to the 2010 McDonald criteria for less than 15 years, with EDSS 1-6, in remission or relapse
- Participant's condition compatible with a maximum of 50 ml of blood collection
- Persons affiliated with a social security plan.
Key exclusion criteria (5 listed)
- MS treatment with steroidal anti-inflammatory drugs, immunomodulators or immunosuppressants within 2 months prior to blood collection
- Persons with acute and chronic infectious disease, autoimmune/inflammatory disease or cancer other than MS
- Pregnant or lactating women
- Be under guardianship,
- Be deprived of liberty by judicial or administrative decision, or be under legal protection.
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 |
|---|---|---|
| 50 ml blodd sampling50 ml blood sampling for genetic analysis (expression profiles of microRNAs) | Genetic | Untreated RRMS patients |
Primary outcome
microRNA expression profiles in immune cell populations from RRMS patients
Time frame: 2 years
RNAseq and/or Nanostring sequencing of PBMCs from RRMS patients
2 secondary outcomes
microRNA expression profiles in unstimulated and stimulated CD4+ T cell populations ex vivo from RRMS patients
Time frame: 2 years
microRNA expression profiles in monocytes from RRMS patients
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
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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.
Frédérique Michel, PhD study director
Institut Pasteur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 50 ml blodd sampling in people with Multiple Sclerosis, Relapsing-Remitting, run by Institut Pasteur at 1 site in France.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frédérique Michel, PhD (+33 1 45 68 86 38, frederique.michel@pasteur.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microRNA expression profiles in immune cell populations from RRMS patients (time frame: 2 years). 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 17 Aug 2022.