A Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple Sclerosis

Study Overview
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Brief Summary
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This is a Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple Sclerosis.

Official Title
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A Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: MSDx Complex-1 Biomarker Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 45 years or older of either gender and of any racial/ethnic group. Subjects must be in generally good health. Subjects must be able and willing to comply with the requirements of the protocol. Must be diagnosed with RRMS Meets the criteria to enter Group 1 or Group 2 Exclusion Criteria: Subject is currently in middle of an active episode of an autoimmune condition (e.g. rheumatoid arthritis, system lupus erythematosis) Subject currently has a condition such as active influenza that would stimulate the immune system

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Inactive Disease<br>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. | Other: MSDx Complex-1 Biomarker Test<br>* A biomarker test for the level of MSDx Complex-1<br>|
| Active Disease<br>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. | Other: MSDx Complex-1 Biomarker Test<br>* A biomarker test for the level of MSDx Complex-1<br>|
| Active Disease - Steroid Therapy<br>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). | Other: MSDx Complex-1 Biomarker Test<br>* A biomarker test for the level of MSDx Complex-1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapsing Remitting, MS