Multiple SclerosisIMMUNOSEPNCT02142764
Preliminary Study for Selective Detection of the CD8+ Myelin Specific T Cell in the Blood of Multiple Sclerosis Patients
A study testing Blood samples in people with Multiple Sclerosis, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Most experts in the field consider Multiple Sclerosis as the main auto immune disease of the central nervous system. In spite of many works, the data in the literature concerning the antigens targeted by the CD8+ T-Cell response are still contradictory and insufficient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to Feb 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Group 1: HLA-A2 patients whose Multiple Sclerosis has just been diagnosed
- 18 year old and older patients,
- HLA-A2 Patients with Multiple Sclerosis or clinically isolated syndrome at high risk of being affected by Multiple Sclerosis (criteria of spatial scattering according to the 2010 or 2005 McDonald's criteria)
- Patients without treatment or treated with immunomodulating therapy
- Patients affiliated to health insurance coverage
- Information and comprehensive agreement signed by the patient and the investigator
Show all 19Show fewer
- Group 2: HLA-A2 patients hospitalized in the neurology department who are not affected with a neuroimmunological disorder
- 18 year old and older patients,
- HLA-A2 patients hospitalized in the neurology department
- Patient not affected by Multiple Sclerosis or a related inflammatory disorder
- Affiliated or profitable subject of a national insurance scheme
- Patients affiliated to health insurance coverage
- Information and comprehensive agreement signed by the patient and the investigator
- Group 3: HLA-A2 Multiple Sclerosis patients treated by Natalizumab therapy
- 18 year old and older patients,
- HLA-A2 patients with relapsing remitting (RR) MS fulfilling McDonald 2005 or 2010 Multiple Sclerosis diagnostic criteria
- Patients treated by Natalizumab therapy for at least 3 months
- Patients affiliated to health insurance coverage
- Information and comprehensive agreement signed by the patient and the investigator
Who cannot join
- Group 1 and 3:
- Patients undergoing immunosuppressive therapy at present or in the past except Natalizumab
- Pregnant women
- Group 2:
- Patients undergoing immunosuppressive therapy at present or in the past
- Patients affected by Multiple Sclerosis or a related disorder
- Pregnant women
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Neurologie - Tripode - Hôpital Pellegrin
Bordeaux, Bordeaux, 33076
About this study
Official title: Preliminary Study for Selective Detection of the CD8+ Myelin Specific T Cell in the Blood of Multiple Sclerosis Patients (MS).
Most experts in the field consider Multiple Sclerosis as the main auto immune disease of the central nervous system. In spite of many works, the data in the literature concerning the antigens targeted by the CD8+ T-Cell response are still contradictory and insufficient.
Read the detailed description
30 patients distributed in 3 groups of 10 patients with specific inclusion criteria will participate in this trial:
- 10 MS patients in early disease onset,
- 10 MS patients under Natalizumab treatment
- and control group of 10 patients with other neurological diseases.
The aim of this clinical trial is to detect the CD8+ myelin specific T-Cells in the blood of Multiple Sclerosis patients.
- Conditions
- Multiple Sclerosis
- Being tested
- Blood samples
- Keywords
- Multiple Sclerosis, CD8+ T-cells, Class I Major Histocompatibility Complex (MHC), pentamers
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesBiological
The blood will be sampled in order to be tested in Immunology, twice, the day they sign their agreement and six months after in case of positive myelin pentamer test (at inclusion and 6 months after the inclusion).
Blood samplesBiological
The blood will be sampled in order to be tested in Immunology, once, the day they sign their agreement (at the inclusion)
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis | Experimental | Human Leukocyte Antigen (HLA)-A2 patients whose Multiple Sclerosis has just been diagnosed Receives: Biological: Blood samples |
| Control | Other | HLA-A2 patients hospitalized in the neurology department who are not affected with a neuroimmunological disorder Receives: Biological: Blood samples |
| Multiple Sclerosis patients treated | Experimental | HLA-A2 Multiple Sclerosis patients treated by Natalizumab therapy Receives: Biological: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of pentamers (> 0,1 % of the CD3 + CD8 + T-cells) will be statistically compared between the 3 groups of patients.
This analysis will enable us to detect CD8+ myelin specific T-cells in the blood of Multiple Sclerosis
Measured: 6 months after the inclusion
Secondary outcomes (3)
The results will be correlated with the patients clinical
Number of attacks relapses and evolution of the Expanded Disability Status Scale from the last 2 years
Measured: 6 months after the inclusion
The results will be correlated with the patients MRI data
MRI activity (load lesions (≥ 9 lesions or not), gadolinium enhanced) from the last 2 years
Measured: 6 months after the inclusion
Description of lymphocyte immunophenotyping and dosage of immunoglobulins in patients treated with Natalizumab
Measured: 6 months after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startNov 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Serono International SA, ADERA
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe OUALLET, MD, Principal investigator, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142764
- Sponsor's protocol ID
- CHUBX 2013/01
- Acronym
- IMMUNOSEP
- Status last verified
- Dec 2016
- First submitted
- 15 May 2014
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study for Selective Detection of the CD8+ Myelin Specific T Cell in the Blood of Multiple Sclerosis Patients (MS).
- ClinicalTrials.gov ID
- NCT02142764
- Acronym / sponsor ID
- IMMUNOSEP / CHUBX 2013/01
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, CD8+ T-cells, Class I Major Histocompatibility Complex (MHC), pentamers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Merck Serono International SA, ADERA
- Study start
- Nov 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 20 May 2014 (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.
Most experts in the field consider Multiple Sclerosis as the main auto immune disease of the central nervous system. In spite of many works, the data in the literature concerning the antigens targeted by the CD8+ T-Cell response are still contradictory and insufficient.
Detailed description
30 patients distributed in 3 groups of 10 patients with specific inclusion criteria will participate in this trial:
- 10 MS patients in early disease onset,
- 10 MS patients under Natalizumab treatment
- and control group of 10 patients with other neurological diseases.
The aim of this clinical trial is to detect the CD8+ myelin specific T-Cells in the blood of Multiple Sclerosis patients.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis | Experimental | Biological: Blood samplesHuman Leukocyte Antigen (HLA)-A2 patients whose Multiple Sclerosis has just been diagnosed |
| Control | Other | Biological: Blood samplesHLA-A2 patients hospitalized in the neurology department who are not affected with a neuroimmunological disorder |
| Multiple Sclerosis patients treated | Experimental | Biological: Blood samplesHLA-A2 Multiple Sclerosis patients treated by Natalizumab therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Group 1: HLA-A2 patients whose Multiple Sclerosis has just been diagnosed
- 18 year old and older patients,
- HLA-A2 Patients with Multiple Sclerosis or clinically isolated syndrome at high risk of being affected by Multiple Sclerosis (criteria of spatial scattering according to the 2010 or 2005 McDonald's criteria)
- Patients without treatment or treated with immunomodulating therapy
- Patients affiliated to health insurance coverage
Key exclusion criteria (7 listed)
- Patients undergoing immunosuppressive therapy at present or in the past except Natalizumab
- Pregnant women
- Patients undergoing immunosuppressive therapy at present or in the past
- Patients affected by Multiple Sclerosis or a related disorder
- Pregnant women
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 |
|---|---|---|
| Blood samplesThe blood will be sampled in order to be tested in Immunology, twice, the day they sign their agreement and six months after in case of positive myelin pentamer test (at inclusion and 6 months after the inclusion). | Biological | Multiple Sclerosis, Multiple Sclerosis patients treated |
| Blood samplesThe blood will be sampled in order to be tested in Immunology, once, the day they sign their agreement (at the inclusion) | Biological | Control |
Primary outcome
Analysis of pentamers (> 0,1 % of the CD3 + CD8 + T-cells) will be statistically compared between the 3 groups of patients.
Time frame: 6 months after the inclusion
This analysis will enable us to detect CD8+ myelin specific T-cells in the blood of Multiple Sclerosis
3 secondary outcomes
The results will be correlated with the patients clinical
Time frame: 6 months after the inclusion
The results will be correlated with the patients MRI data
Time frame: 6 months after the inclusion
Description of lymphocyte immunophenotyping and dosage of immunoglobulins in patients treated with Natalizumab
Time frame: 6 months after the inclusion
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 7 Dec 2016.
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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.
Jean-Christophe OUALLET, MD principal investigator
University Hospital Bordeaux, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples in people with Multiple Sclerosis, run by University Hospital, Bordeaux 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 19 inclusion and 7 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 7 Dec 2016. 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?
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?
Analysis of pentamers (> 0,1 % of the CD3 + CD8 + T-cells) will be statistically compared between the 3 groups of patients. (time frame: 6 months after the inclusion). 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 7 Dec 2016.