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No participants were enrolled before closing the study
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| Name | Class |
|---|---|
| Milton S. Hershey Medical Center | OTHER |
| Bristol-Myers Squibb | INDUSTRY |
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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).
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| 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. |
| |
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerebrospinal and Blood Serum Semaphorin 4A Levels | Diagnostic Test | Cerebrospinal fluid and serum will be collected at baseline to measure the level of semaphorin 4A. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Serum Semaphorin 4A Levels | Measure blood serum semaphorin 4A levels at baseline | Baseline |
| Cerebrospinal Fluid Semaphorin 4A Levels | Measure cerebrospinal fluid semaphorin 4A levels at baseline | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 Months |
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Inclusion Criteria:
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:
Exclusion Criteria:
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Multiple sclerosis and non-MS controls
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| Name | Affiliation | Role |
|---|---|---|
| Stanley Cohan, MD, PhD | Providence Health and Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | United States |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| C564597 | Cone-Rod Dystrophy 10 |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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Sema4A is measured in serum and CSF by a Sema-4A-specific ELISA (Biomatik). Frozen serum and CSF samples will be sent to laboratory at Penn State for these measurements. Whole blood and CSF will be obtained from each subject at the screening/baseline visit, with follow-up whole blood at 6 and 12 months in patient Groups 1-3. We will also measure myelin basic protein levels in the CSF and measure lymphocyte subsets in whole blood for Groups 1-3. These two tests will be performed by the Providence clinical lab.
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |