Multiple SclerosisNCT03486665
Characterization of White Blood Cells Sub-populations From Multiple Sclerosis Patients.
An observational study of Multiple Sclerosis, run by Bioimmunate at 1 site in Israel.
Trial summary
Multiple sclerosis (MS) is a chronic progressive neurological autoimmune disease, that gradually affects patient's quality of life. There are about 2.5 millions patients world wide, with an increasing cost Burdon. Up to date, it remains unclear who are the exact cells to initiate the disease. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Blood Sampling and CSF Sampling
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 24 Apr 2018to Mar 2020
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 18 to 70 years old patients with MS defined according to the revised diagnostic criteria of MacDonald and are followed by the neurology or physical medicine and rehabilitation center or healthy volunteers.
Who may be able to join
- Patients with diagnosis of MS according to the revised criteria of McDonald or healthy volunteers
- Ability to provide written informed consent.
Who cannot join
- Active malignant disease
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Center
Jerusalem
Ariel Ginzberg, PHD, +972 2 6776939
Dimitrios Karussis, Prof.
About this study
Official title: Characterization and Quantitative Analysis of White Blood Cells in the Blood and Cerebrospinal Fluid of MS Patients
Multiple sclerosis (MS) is a chronic progressive neurological autoimmune disease, that gradually affects patient's quality of life. There are about 2.5 millions patients world wide, with an increasing cost Burdon. Up to date, it remains unclear who are the exact cells to initiate the disease. During the disease, the repertoire of cells expands and undergoes changes. The purpose of this study is to characterize those changes.
- Conditions
- Multiple Sclerosis
- Being tested
- Blood Sampling, CSF Sampling
- 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 SamplingOther
Blood samples will be taken from all patients and healthy volunteers.
CSF SamplingOther
CSF sample will be taken from hospitalized newly diagnosed patients only.
| Study group | Role | What they receive |
|---|---|---|
| Diagnosed with Multiple Sclerosis | Patients previously diagnosed with Multiple Sclerosis Receives: Other: Blood Sampling | |
| Newly Diagnosed with Multiple Sclerosis | Patients diagnosed for the first time with Multiple Sclerosis and hospitalized Receives: Other: Blood Sampling; Other: CSF Sampling | |
| Healthy Volunteers | Health volunteers who do not have an autoimmune diseases, including Multiple Sclerosis Receives: Other: Blood Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of disease related white blood cells from blood and/ or CSF
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start24 Apr 2018
- Primary completionSep 2018 (estimated)
- Study completionMar 2020 (estimated)
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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioimmunate
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486665
- Sponsor's protocol ID
- BIT-001
- Status last verified
- Jul 2018
- First submitted
- 21 Mar 2018
- Last updated
- 19 Jul 2018
- 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 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Quantitative Analysis of White Blood Cells in the Blood and Cerebrospinal Fluid of MS Patients
- ClinicalTrials.gov ID
- NCT03486665
- Acronym / sponsor ID
- BIT-001
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- BioimmunateIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 3 Apr 2018 (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.
Multiple sclerosis (MS) is a chronic progressive neurological autoimmune disease, that gradually affects patient's quality of life. There are about 2.5 millions patients world wide, with an increasing cost Burdon. Up to date, it remains unclear who are the exact cells to initiate the disease. During the disease, the repertoire of cells expands and undergoes changes. The purpose of this study is to characterize those changes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diagnosed with Multiple Sclerosis | – | Other: Blood SamplingPatients previously diagnosed with Multiple Sclerosis |
| Newly Diagnosed with Multiple Sclerosis | – | Other: Blood Sampling, Other: CSF SamplingPatients diagnosed for the first time with Multiple Sclerosis and hospitalized |
| Healthy Volunteers | – | Other: Blood SamplingHealth volunteers who do not have an autoimmune diseases, including Multiple Sclerosis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 18 to 70 years old patients with MS defined according to the revised diagnostic criteria of MacDonald and are followed by the neurology or physical medicine and rehabilitation center or healthy volunteers.
Key inclusion criteria (2 listed)
- Patients with diagnosis of MS according to the revised criteria of McDonald or healthy volunteers
- Ability to provide written informed consent.
Key exclusion criteria (1 listed)
- Active malignant disease
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 SamplingBlood samples will be taken from all patients and healthy volunteers. | Other | Diagnosed with Multiple Sclerosis, Healthy Volunteers, Newly Diagnosed with Multiple Sclerosis |
| CSF SamplingCSF sample will be taken from hospitalized newly diagnosed patients only. | Other | Newly Diagnosed with Multiple Sclerosis |
Primary outcome
Quantification of disease related white blood cells from blood and/ or CSF
Time frame: through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Bioimmunate at 1 site in Israel.
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 2 inclusion and 1 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 19 Jul 2018. 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 Israel. 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 Sigalit Carmel, MD, MSc (+97225649302, sigalit@bioimmunate.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of disease related white blood cells from blood and/ or CSF (time frame: through study completion, an average of 6 months). 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 19 Jul 2018.