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This is a Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple Sclerosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inactive Disease | Inactive disease; RRMS patients who have been treated with monthly infusions of Tysabri for 12 months and have had stable disease for the last 6 months or more and show stable or improving neurological deficits over 3 months on Tysabri. |
| |
| Active Disease | Active disease; RRMS patients in acute clinical relapse or with active MRI. Blood sample obtained within 30 days of event AND before steroid treatment (or) patients in early disease on or off first line agents with relapse in prior 3 months AND not treated with steroids for at least 2 months. |
| |
| Active Disease - Steroid Therapy | Patient with a diagnosis of relapsing remitting multiple sclerosis (RRMS) who is about to begin steroid therapy for a relapse in clinical symptoms (either diagnosed clinically or via gadolinium MRI). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSDx Complex-1 Biomarker Test | Other | A biomarker test for the level of MSDx Complex-1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker Differential | A difference in the levels of Complex-1 between subjects with controlled, stable MS vs. subjects in acute MS relapse | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker reduction with steroid therapy | A decrease in the level of MSDx Complex-1 in response to steroid therapy for a relapse of MS. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who currently diagnosed with relapsing remitting multiple sclerosis
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| Name | Affiliation | Role |
|---|---|---|
| Jeanette K Wendt, MD | Northwest NeuroSpecialists, PLLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwest NeuroSpecialists, PLLC | Tucson | Arizona | 85741 | United States |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| 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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Blood remaining after testing for MSDx Complex-1 will be retained for evaluation for other MS biomarkers
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |