Multiple Sclerosis Clinical Trial
— Sema4A MSOfficial title:
Sema 4A as a Marker for Inflammatory Disease in Multiple Sclerosis
Verified date | August 2023 |
Source | Providence Health & Services |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 25, 2023 |
Est. primary completion date | October 25, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Providence St. Vincent Medical Center | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Providence Health & Services | Bristol-Myers Squibb, Milton S. Hershey Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood Serum Semaphorin 4A Levels | Measure blood serum semaphorin 4A levels at baseline | Baseline | |
Primary | Cerebrospinal Fluid Semaphorin 4A Levels | Measure cerebrospinal fluid semaphorin 4A levels at baseline | Baseline | |
Secondary | 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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