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The purpose of this study is to compare biomarker levels in Multiple Sclerosis (MS) patients before and after beginning Natalizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tysabri Group | Patients with a diagnosis of relapsing remitting multiple sclerosis (RRMS) who is about to begin Natalizumab (Tysabri) therapy for a relapse in clinical symptoms (either diagnosed clinically or via gadolinium MRI). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSDX Complex-1 Biomarker test | Other | MSDX Complex-1 Biomarker test |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in MSDX Complex-1 between baseline and 6-month visit | This outcome measure will evaluate a difference in the level of MSDX Complex-1 form the baseline visit to the 6-month visit. MSDX Complex-1 is a biomarker for MS disease activity and its change should correspond with a change in the disease activity in MS. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Gadolinium MRI and MSDX Complex-1 level | This outcome will evaluate whether a change seen in a Gadolinium MRI (a diagnostic test for MS) matches with a change in the MSDX Complex-1 level in a patient with MS. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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The study populations for this study is a patient with a diagnosis of relapsing remitting multiple sclerosis (RRMS) who is about to begin Natalizumab (Tysabri) therapy for a relapse in clinical symptoms (either diagnosed clinically or via gadolinium MRI).
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| Name | Affiliation | Role |
|---|---|---|
| Jeannette 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 |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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Blood remaining after the biomarker test is completed will be retained for possible evaluation of additional biomarkers
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |