Relapsing Remitting Multiple Sclerosis
Conditions
Keywords
MS, RRMS, RR Multiple Sclerosis
Brief summary
The purpose of this study is to compare biomarker levels in Multiple Sclerosis (MS) patients before and after beginning Natalizumab.
Interventions
MSDX Complex-1 Biomarker test
Sponsors
MSDx, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of clinically definite relapsing remitting MS (RRMS) 2. Age 45 years and older 3. Willing and able to provide written informed consent 4. Patient has high disease activity. 5. Patient is about to begin Natalizumab (Tysabri) therapy.
Exclusion criteria
1. Any clinically significant disease other than MS that is likely to interfere with the evaluation of CDMS 2. Known infectious or hematological disease. 3. Unwilling or unable to comply with the requirements of this protocol 4. Subject can not have a gadolinium enhanced MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in MSDX Complex-1 between baseline and 6-month visit | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gadolinium MRI and MSDX Complex-1 level | 6 months | 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. |
Countries
United States
Outcome results
None listed