Multiple Sclerosis
Item
patient diagnosed with clinically definite ms according to mcdonald criteria #1-#4
boolean
C0026769 (UMLS CUI [1])
Age
Item
age 18-55
boolean
C0001779 (UMLS CUI [1])
Disease Relapsing-remitting course
Item
have a rr disease course
boolean
C0012634 (UMLS CUI [1,1])
C3808177 (UMLS CUI [1,2])
Kurtzke multiple sclerosis rating scale
Item
have edss scores less than or equal to 5.0
boolean
C0451246 (UMLS CUI [1])
disease length
Item
have a disease duration of one day to 20 years
boolean
C0872146 (UMLS CUI [1])
Relapse Quantity | Relapse Neurologic Manifestations | Relapse Consistent with Acute Relapsing Multiple Sclerosis | Relapse Progression Kurtzke multiple sclerosis rating scale
Item
have at least one medically documented clinical relapse within the 12 months prior to randomization (for eligibility, a pre-study relapse will be defined as neurologic symptoms and signs documented by review of the history with the subject or in the medical record, of sufficient severity and duration to be determined by the investigator as consistent with an acute ms relapse; the relapse does not need to have been treated to qualify) and/or have progression of ≥1.0 points in edss in the previous year
boolean
C0035020 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0035020 (UMLS CUI [2,1])
C0027854 (UMLS CUI [2,2])
C0035020 (UMLS CUI [3,1])
C0332290 (UMLS CUI [3,2])
C0393664 (UMLS CUI [3,3])
C0035020 (UMLS CUI [4,1])
C0242656 (UMLS CUI [4,2])
C0451246 (UMLS CUI [4,3])
Brain Gadolinium-Enhancing Lesion Quantity MRI | Lesion of brain Quantity MRI T2 weighted | Lesion of brain Consistent with Multiple Sclerosis
Item
have ≥1 gd-enhancing brain lesion on a monthly run-in baseline mri and ≥2 t2 brain lesions consistent with ms on the screening scan
boolean
C0006104 (UMLS CUI [1,1])
C1333400 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0024485 (UMLS CUI [1,4])
C0221505 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C2238849 (UMLS CUI [2,3])
C0221505 (UMLS CUI [3,1])
C0332290 (UMLS CUI [3,2])
C0026769 (UMLS CUI [3,3])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Exclusion Criteria omitted
Item
none of the exclusion criteria
boolean
C0680251 (UMLS CUI [1,1])
C0750563 (UMLS CUI [1,2])
Standard therapy Disease Modification | Interferon-beta | glatiramer acetate | Immunoglobulins, Intravenous | Plasmapheresis
Item
previous treatment 3 months prior to study entry with standard disease-modifying therapy (interferon-beta and glatiramer acetate, ivig and plasmaphoresis).
boolean
C2936643 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C0015980 (UMLS CUI [2])
C0289884 (UMLS CUI [3])
C0085297 (UMLS CUI [4])
C0032134 (UMLS CUI [5])
Immunosuppressive Agents | Mitoxantrone | Cyclophosphamide | Cladribine | fludarabine | Cyclosporine | Whole-Body Irradiation | Immunomodulation | Azathioprine | Methotrexate | Cellcept | natalizumab | Immunomodulators | Monoclonal antibody preparation
Item
previous treatment 12 months prior to study entry with immunosuppressant agents, e.g., mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine or total body irradiation or any other concomitant immunomodulatory therapies (e.g., azathioprine, methotrexate,, cellcept®, natalizumab, and other immunomodulators/monoclonal agents).
boolean
C0021081 (UMLS CUI [1])
C0026259 (UMLS CUI [2])
C0010583 (UMLS CUI [3])
C0092801 (UMLS CUI [4])
C0059985 (UMLS CUI [5])
C0010592 (UMLS CUI [6])
C0043162 (UMLS CUI [7])
C1963758 (UMLS CUI [8])
C0004482 (UMLS CUI [9])
C0025677 (UMLS CUI [10])
C0592558 (UMLS CUI [11])
C1172734 (UMLS CUI [12])
C1527392 (UMLS CUI [13])
C1298636 (UMLS CUI [14])
Steroid therapy
Item
patients who received steroid treatment 30 days prior to the mri scan date
boolean
C0149783 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling
Item
women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
Blood test abnormal
Item
abnormal blood tests, performed during the screening visit (see adverse events section)
boolean
C0854146 (UMLS CUI [1])