Sema 4A as a Marker for Inflammatory Disease in Multiple Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Providence Health & Services
- Locations
- 1
- Primary Endpoint
- Blood Serum Semaphorin 4A Levels
Study Overview
Brief 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 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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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:
- •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
Exclusion Criteria
- •There are no exclusion criteria for this study.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Correlation between Semaphorin 4A levels and Demyelination and Axonal Degeneration(12 Months)