Relapsing Multiple SclerosisSema4A MSNCT05077956
Sema 4A as a Marker for Inflammatory Disease in Multiple Sclerosis
An observational study of Relapsing Multiple Sclerosis and Multiple Sclerosis, run by Providence Health & Services at 1 site in United States.
Trial summary
Measure serum and cerebrospinal fluid Sema4A levels in female subjects with newly diagnosed and untreated relapsing multiple sclerosis, clinically stable relapsing multiple sclerosis receiving disease modifying therapy, relapsing multiple sclerosis receiving disease modifying therapy with breakthrough disease, or… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Relapsing Multiple Sclerosis, Multiple Sclerosis
- What is being tested?
- Cerebrospinal and Blood Serum Semaphorin 4A Levels
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2021to 25 Oct 2023
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Multiple sclerosis and non-MS controls
Who may be able to join
- Female aged 18-55, inclusive at the time of consent
- Not pregnant at the time of the screening/baseline visit
- Able to understand the purpose, benefits, and risks of the study; willing and able to adhere to the study requirements; able and provide informed consent in English
- Meet the criteria of one of the four groups at the time of consent:
- Group 1: subjects who have recently been diagnosed with MS, have had a clinical attack within the last 6 months, have not received steroids in the last 30 days, and have not started on a disease modifying therapy
- Group 2: subjects with clinically stable relapsing MS, with no evidence of clinical relapse for at least the past 12 weeks, and have no gadolinium enhancing lesions on MRI in the prior 4 weeks, who are receiving a FDA-approved MS DMT
- Group 3: subjects with relapsing MS on a FDA-approved DMT but with evidence of breakthrough disease, with a documented clinical relapse and/or gadolinium-enhancing lesion(s) on brain or spinal cord MRI taken within the 4 weeks
- Group 4: subjects without evidence of inflammatory systemic or CNS disease, who require CSF removal for some other cause, such as for idiopathic intracranial hypertension or communicating hydrocephalus
Who cannot join
- There are no exclusion criteria for this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence St. Vincent Medical Center
Portland, Oregon, 97225
About this study
Measure serum and cerebrospinal fluid Sema4A levels in female subjects with newly diagnosed and untreated relapsing multiple sclerosis, clinically stable relapsing multiple sclerosis receiving disease modifying therapy, relapsing multiple sclerosis receiving disease modifying therapy with breakthrough disease, or non-multiple sclerosis controls (patients without inflammatory central nervous system disease).
Read the detailed description
This pilot study proposal will further investigate whether Semaphorin 4A (Sema4A) elevation in cerebrospinal fluid (CSF) and serum is a potential disease activity biomarker in patients with multiple sclerosis (MS).
A total of 40 female subjects between the ages of 18-55 who meet the criteria of one of the following four groups will be enrolled to measure serum and CSF Sema4A levels:
- Group 1: Newly diagnosed/untreated Relapsing MS patients (RMS)
- Group 2: Clinically stable RMS patients receiving disease modifying therapy (DMT)
- Group 3: RMS patients receiving DMT with breakthrough disease
- Group 4: Non-MS controls (patients without inflammatory CNS disease)
Participants will provide blood and CSF samples at baseline for Sema4A analysis. Follow up blood samples will be collected at 6 months and 12 months as part of lymphocyte subset analysis. Participation will end after 12 months of follow up.
The expected risks are related to blood draws and lumbar puncture. Lumbar puncture will be performed under fluoroscopy to decrease risks of pain from repeated needle punctures, injury from incorrect placement of the needle, and post puncture CSF leakage.
- Conditions
- Relapsing Multiple Sclerosis, Multiple Sclerosis
- Being tested
- Cerebrospinal and Blood Serum Semaphorin 4A Levels
- Keywords
- multiple sclerosis, relapsing multiple sclerosis, semaphorin 4A, sema4a, disease modifying therapy, biomarker
- Medical subject headings
- Multiple Sclerosis, Cone-Rod Dystrophy 10
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebrospinal and Blood Serum Semaphorin 4A LevelsDiagnostic test
Cerebrospinal fluid and serum will be collected at baseline to measure the level of semaphorin 4A.
| Study group | Role | What they receive |
|---|---|---|
| Recently Diagnosed Multiple Sclerosis | Recently diagnosed MS, who have had a clinical attack within the last 6 months, have not received steroids in the last 30 days, and have not started on a disease modifying therapy (DMT). Receives: Diagnostic Test: Cerebrospinal and Blood Serum Semaphorin 4A Levels | |
| Clinically Stable Relapsing Multiple Sclerosis | Clinically stable relapsing MS, who are receiving a FDA-approved MS DMT and have had no evidence of a clinical relapse for at least the past 12 weeks or gadolinium enhancing lesions on MRI in the prior 4 weeks. Receives: Diagnostic Test: Cerebrospinal and Blood Serum Semaphorin 4A Levels | |
| Relapsing Multiple Sclerosis on Disease Modifying Therapy | Relapsing MS on a FDA-approved DMT with evidence of recent breakthrough disease, with a documented clinical relapse and/or gadolinium-enhancing lesion(s) on brain or spinal cord MRI taken within the 4 weeks. Receives: Diagnostic Test: Cerebrospinal and Blood Serum Semaphorin 4A Levels | |
| Healthy Volunteers | Patients without evidence of inflammatory systemic or CNS disease, who require CSF removal for some other cause, such as for idiopathic intracranial hypertension or communicating hydrocephalus. Receives: Diagnostic Test: Cerebrospinal and Blood Serum Semaphorin 4A Levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Serum Semaphorin 4A Levels
Measure blood serum semaphorin 4A levels at baseline
Measured: Baseline
Cerebrospinal Fluid Semaphorin 4A Levels
Measure cerebrospinal fluid semaphorin 4A levels at baseline
Measured: Baseline
Secondary outcomes (1)
Correlation between Semaphorin 4A levels and Demyelination and Axonal Degeneration
MRI will be performed at 6 months and 12 months to evaluate if there is a correlation between baseline semaphorin 4 A levels and demyelination and axonal degeneration.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start19 Oct 2021
- Primary completion25 Oct 2023 (estimated)
- Study completion25 Oct 2023 (estimated)
Why it stopped: No participants were enrolled before closing the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Collaborators
- Milton S. Hershey Medical Center, Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Stanley Cohan, MD, PhD, Principal investigator, Providence Health and Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077956
- Sponsor's protocol ID
- 2021000250
- Acronym
- Sema4A MS
- Status last verified
- Aug 2023
- First submitted
- 1 Oct 2021
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sema 4A as a Marker for Inflammatory Disease in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05077956
- Acronym / sponsor ID
- Sema4A MS / 2021000250
- Conditions
- Relapsing Multiple Sclerosis, Multiple Sclerosis
- Keywords
- multiple sclerosis, relapsing multiple sclerosis, semaphorin 4A, sema4a, disease modifying therapy, biomarker
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled before closing the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Collaborators
- Milton S. Hershey Medical Center, Bristol-Myers Squibb
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 25 Oct 2023 (estimated)
- Study completion
- 25 Oct 2023 (estimated)
- First posted
- 14 Oct 2021 (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.
Measure serum and cerebrospinal fluid Sema4A levels in female subjects with newly diagnosed and untreated relapsing multiple sclerosis, clinically stable relapsing multiple sclerosis receiving disease modifying therapy, relapsing multiple sclerosis receiving disease modifying therapy with breakthrough disease, or non-multiple sclerosis controls (patients without inflammatory central nervous system disease).
Detailed description
This pilot study proposal will further investigate whether Semaphorin 4A (Sema4A) elevation in cerebrospinal fluid (CSF) and serum is a potential disease activity biomarker in patients with multiple sclerosis (MS).
A total of 40 female subjects between the ages of 18-55 who meet the criteria of one of the following four groups will be enrolled to measure serum and CSF Sema4A levels:
- Group 1: Newly diagnosed/untreated Relapsing MS patients (RMS)
- Group 2: Clinically stable RMS patients receiving disease modifying therapy (DMT)
- Group 3: RMS patients receiving DMT with breakthrough disease
- Group 4: Non-MS controls (patients without inflammatory CNS disease)
Participants will provide blood and CSF samples at baseline for Sema4A analysis. Follow up blood samples will be collected at 6 months and 12 months as part of lymphocyte subset analysis. Participation will end after 12 months of follow up.
The expected risks are related to blood draws and lumbar puncture. Lumbar puncture will be performed under fluoroscopy to decrease risks of pain from repeated needle punctures, injury from incorrect placement of the needle, and post puncture CSF leakage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Recently Diagnosed Multiple Sclerosis | – | Diagnostic Test: Cerebrospinal and Blood Serum Semaphorin 4A LevelsRecently diagnosed MS, who have had a clinical attack within the last 6 months, have not received steroids in the last 30 days, and have not started on a disease modifying therapy (DMT). |
| Clinically Stable Relapsing Multiple Sclerosis | – | Diagnostic Test: Cerebrospinal and Blood Serum Semaphorin 4A LevelsClinically stable relapsing MS, who are receiving a FDA-approved MS DMT and have had no evidence of a clinical relapse for at least the past 12 weeks or gadolinium enhancing lesions on MRI in the prior 4 weeks. |
| Relapsing Multiple Sclerosis on Disease Modifying Therapy | – | Diagnostic Test: Cerebrospinal and Blood Serum Semaphorin 4A LevelsRelapsing MS on a FDA-approved DMT with evidence of recent breakthrough disease, with a documented clinical relapse and/or gadolinium-enhancing lesion(s) on brain or spinal cord MRI taken within the 4 weeks. |
| Healthy Volunteers | – | Diagnostic Test: Cerebrospinal and Blood Serum Semaphorin 4A LevelsPatients without evidence of inflammatory systemic or CNS disease, who require CSF removal for some other cause, such as for idiopathic intracranial hypertension or communicating hydrocephalus. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Multiple sclerosis and non-MS controls
Key inclusion criteria (8 listed)
- Female aged 18-55, inclusive at the time of consent
- Not pregnant at the time of the screening/baseline visit
- Able to understand the purpose, benefits, and risks of the study; willing and able to adhere to the study requirements; able and provide informed consent in English
- Meet the criteria of one of the four groups at the time of consent:
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study.
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 |
|---|---|---|
| Cerebrospinal and Blood Serum Semaphorin 4A LevelsCerebrospinal fluid and serum will be collected at baseline to measure the level of semaphorin 4A. | Diagnostic test | Clinically Stable Relapsing Multiple Sclerosis, Healthy Volunteers, Recently Diagnosed Multiple Sclerosis, Relapsing Multiple Sclerosis on Disease Modifying Therapy |
Primary outcome
Blood Serum Semaphorin 4A Levels
Time frame: Baseline
Measure blood serum semaphorin 4A levels at baseline
Cerebrospinal Fluid Semaphorin 4A Levels
Time frame: Baseline
Measure cerebrospinal fluid semaphorin 4A levels at baseline
1 secondary outcome
Correlation between Semaphorin 4A levels and Demyelination and Axonal Degeneration
Time frame: 12 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
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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.
Stanley Cohan, MD, PhD principal investigator
Providence Health and Services
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 Relapsing Multiple Sclerosis and Multiple Sclerosis, run by Providence Health & Services at 1 site in United States.
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 8 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: withdrawn, as of the sponsor's last update on 7 Aug 2023. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Blood Serum Semaphorin 4A Levels (time frame: Baseline). The study lists 2 primary outcomes in all. 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 Aug 2023.