Interferon beta-1a Duration | interferon beta-1b Duration
Item
must have been receiving interferon-beta-1a or interferon-beta-1b for a minimum of 12 consecutive months prior to enrollment
boolean
C0254119 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0244713 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Multiple Sclerosis, Relapsing-Remitting
Item
relapsing-remitting multiple sclerosis according to poser or mcdonald criteria
boolean
C0751967 (UMLS CUI [1])
EDSS
Item
edss score of 6 or less
boolean
C0451246 (UMLS CUI [1])
Neutralizing Antibodies titer measurement | Cytopathic effect Assay | Myxovirus Resistance Protein Assay | Interferon-beta Injection | Tests Quantity
Item
nab titre >or equal to 20 via cpe assay or >or equal to 100 via mxa protein assay measured at least 24 hours after last interferon-beta injection on two consecutive tests at least 3 months apart
boolean
C0475463 (UMLS CUI [1,1])
C0474643 (UMLS CUI [1,2])
C0333467 (UMLS CUI [2,1])
C1510438 (UMLS CUI [2,2])
C0072378 (UMLS CUI [3,1])
C1510438 (UMLS CUI [3,2])
C0015980 (UMLS CUI [4,1])
C1828121 (UMLS CUI [4,2])
C0392366 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
Biological Availability Reduced | Expression Relative Myxovirus Resistance Proteins | Expression Relative Messenger RNA Glyceraldehyde-3-phosphate dehydrogenase
Item
reduced bioavailability (relative expression of mxa mrna/gapdh
boolean
C0005508 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C1171362 (UMLS CUI [2,1])
C0205345 (UMLS CUI [2,2])
C0072378 (UMLS CUI [2,3])
C1171362 (UMLS CUI [3,1])
C0205345 (UMLS CUI [3,2])
C0035696 (UMLS CUI [3,3])
C3536868 (UMLS CUI [3,4])
severe allergic reaction Albumin Human | severe allergic reaction Interferons | severe allergic reaction Methylprednisolone | severe allergic reaction Investigational New Drugs Component | anaphylaxis Severe Albumin Human | anaphylaxis Severe Interferons | anaphylaxis Severe Methylprednisolone | anaphylaxis Severe Investigational New Drugs Component
Item
history of severe allergic or anaphylactic reaction to human albumin, to any interferon, methylprednisolone or to any other component of study drugs
boolean
C2220378 (UMLS CUI [1,1])
C0304925 (UMLS CUI [1,2])
C2220378 (UMLS CUI [2,1])
C0021747 (UMLS CUI [2,2])
C2220378 (UMLS CUI [3,1])
C0025815 (UMLS CUI [3,2])
C2220378 (UMLS CUI [4,1])
C0013230 (UMLS CUI [4,2])
C1705248 (UMLS CUI [4,3])
C0002792 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0304925 (UMLS CUI [5,3])
C0002792 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0021747 (UMLS CUI [6,3])
C0002792 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0025815 (UMLS CUI [7,3])
C0002792 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0013230 (UMLS CUI [8,3])
C1705248 (UMLS CUI [8,4])
Systemic disease Clinical Significance
Item
clinically significant systemic illness
boolean
C0442893 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Poor hypertension control | Diabetes mellitus poor control | Osteoporosis Poorly controlled
Item
history of poorly controlled hypertension, diabetes, or osteoporosis
boolean
C0421190 (UMLS CUI [1])
C0860161 (UMLS CUI [2])
C0029456 (UMLS CUI [3,1])
C3853134 (UMLS CUI [3,2])
Seizures Uncontrolled
Item
history of uncontrolled seizures within 3 months of enrollment
boolean
C0036572 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Depressive disorder | Feeling suicidal
Item
history of depression or suicidal ideation within 3 months of enrollment
boolean
C0011581 (UMLS CUI [1])
C0424000 (UMLS CUI [2])
local infection Serious | Abscess | Cellulitis | Sepsis
Item
serious local infection (abscess or cellulitis) or systemic infection within 8 weeks of study
boolean
C1400591 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0000833 (UMLS CUI [2])
C0007642 (UMLS CUI [3])
C0243026 (UMLS CUI [4])
Blood test abnormal
Item
abnormal screening blood tests
boolean
C0854146 (UMLS CUI [1])