Age
Item
1. male and female subjects aged 18-65 years old, inclusive.
boolean
C0001779 (UMLS CUI [1])
Multiple Sclerosis
Item
2. a diagnosis of ms as defined by the mcdonald 2010 criteria for ms.
boolean
C0026769 (UMLS CUI [1])
Multiple sclerosis relapse | Relapse Quantity
Item
3. relapsing form of ms, defined as at least one relapse in the prior 5 years.
boolean
C0856120 (UMLS CUI [1])
C0035020 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
EDSS
Item
4. expanded disability status scale (edss) score of 0 to 5.5, inclusive.
boolean
C0451246 (UMLS CUI [1])
Language skills English | Questionnaires Completion | Tests Cognitive Completion
Item
5. english language skills adequate for the completion of questionnaires and cognitive measures.
boolean
C1145677 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0034394 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0392366 (UMLS CUI [3,1])
C1516691 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
Progressive multiple sclerosis
Item
1. subjects with progressive ms.
boolean
C1095979 (UMLS CUI [1])
Medical contraindication Rebif | Medical contraindication Tecfidera | Gastrointestinal Disease | Needle phobia | Liver disease
Item
2. subjects with a contraindications for standard treatment with rebif or tecfidera including gi disease, needle phobia, liver disease.
boolean
C1301624 (UMLS CUI [1,1])
C0752980 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C3556178 (UMLS CUI [2,2])
C0017178 (UMLS CUI [3])
C0338906 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
Therapeutic procedure
Item
3. subjects treated with:
boolean
C0087111 (UMLS CUI [1])
Intravenous Immunoglobulins High dose
Item
high dose intravenous immunoglobulin within 2 months prior to study entry
boolean
C0085297 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
natalizumab
Item
natalizumab within 3 months prior to study entry
boolean
C1172734 (UMLS CUI [1])
Immunosuppressive Agents | Biological Response Modifiers | Cyclophosphamide | Mitoxantrone | Azathioprine | Methotrexate | rituximab | ofatumumab | ocrelizumab | alemtuzumab
Item
immunosuppressive/immunomodulatory medications including cyclophosphamide, mitoxantrone, azathioprine, methotrexate, rituximab, ofatumumab, ocrelizumab, or alemtuzumab at any time.
boolean
C0021081 (UMLS CUI [1])
C0005525 (UMLS CUI [2])
C0010583 (UMLS CUI [3])
C0026259 (UMLS CUI [4])
C0004482 (UMLS CUI [5])
C0025677 (UMLS CUI [6])
C0393022 (UMLS CUI [7])
C1832027 (UMLS CUI [8])
C1882138 (UMLS CUI [9])
C0383429 (UMLS CUI [10])
Absolute lymphocyte count
Item
4. subjects with absolute lymphocyte count < 800 cells (mm3).
boolean
C3544087 (UMLS CUI [1])
Nervous system disorder | Mental disorders
Item
5. subjects with any of the following neurologic/psychiatric disorder:
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
Severe depression
Item
severe depression during the past 12 months before screening;
boolean
C0588008 (UMLS CUI [1])
Substance Use Disorders | Factor Interferes with Compliance behavior | Mental condition Serious Interferes with Compliance behavior | Factor Interferes with Protocol Compliance | Mental condition Serious Interferes with Protocol Compliance
Item
history of substance abuse (treatment or alcohol) or any other factor (i.e., serious psychiatric condition) that may interfere with the subject's ability to cooperate and comply with the study procedures;
boolean
C0038586 (UMLS CUI [1])
C1521761 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C1321605 (UMLS CUI [3,4])
C1521761 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C3840291 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C0521102 (UMLS CUI [5,3])
C0525058 (UMLS CUI [5,4])
MRI scan Receive Unable | Claustrophobia | Hypersensitivity Gadolinium DTPA
Item
6. subjects unable to undergo mri scans, including claustrophobia or history of hypersensitivity to gadolinium-dtpa.
boolean
C0024485 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0008909 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0060933 (UMLS CUI [3,2])
Pregnancy | HCG pregnancy test Positive | Breast Feeding
Item
7. pregnant or nursing females, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test.
boolean
C0032961 (UMLS CUI [1])
C0546577 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3])
Childbearing Potential | Childbearing Potential Sexual Abstinence | Childbearing Potential Sexually active Contraceptive methods
Item
8. female subjects of childbearing potential, defined as all females physiologically capable of becoming pregnant, unless they agree to abstinence or, if sexually active, the use of contraception.
boolean
C3831118 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0241028 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
Hypersensitivity Investigational Therapy | Hypersensitivity Therapy Similar
Item
9. history of hypersensitivity to any of the study treatments or to treatments of similar chemical classes.
boolean
C0020517 (UMLS CUI [1,1])
C0949266 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C2348205 (UMLS CUI [2,3])
Liver function tests abnormal
Item
10. subjects with abnormal liver function test (lft) levels
boolean
C0151766 (UMLS CUI [1])