Informed Consent
Item
informed consent and assent as appropriate
boolean
C0021430 (UMLS CUI [1])
Body Weight
Item
must have a body weight of ≥30 kg
boolean
C0005910 (UMLS CUI [1])
Multiple Sclerosis, Relapsing-Remitting
Item
must have a diagnosis of rrms as defined by the revised consensus definition for pediatric multiple sclerosis (ms)
boolean
C0751967 (UMLS CUI [1])
Ambulatory | EDSS
Item
must be ambulatory with a converted krutzke baseline expanded disability status scale (edss) score between 0 and 5.0, inclusive
boolean
C0439841 (UMLS CUI [1])
C0451246 (UMLS CUI [2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Progressive Relapsing
Item
primary progressive, secondary progressive, or progressive relapsing ms.
boolean
C0751964 (UMLS CUI [1])
C0751965 (UMLS CUI [2])
C0393666 (UMLS CUI [3])
Demyelinating Diseases | Encephalomyelitis, Acute Disseminated | Systemic autoimmune disease | Sjogren's Syndrome | Lupus Erythematosus | Metabolic Diseases | Dystrophy | Communicable Diseases
Item
history of disorders mimicking ms, such as other demyelinating disorders (e.g., acute disseminated encephalomyelitis), systemic autoimmune disorders (e.g., sjögren disease and lupus erythematosus), metabolic disorders (e.g., dystrophies), and infectious disorders.
boolean
C0011303 (UMLS CUI [1])
C0014059 (UMLS CUI [2])
C2895206 (UMLS CUI [3])
C1527336 (UMLS CUI [4])
C0409974 (UMLS CUI [5])
C0025517 (UMLS CUI [6])
C0333606 (UMLS CUI [7])
C0009450 (UMLS CUI [8])
Allergic Reactions Severe | Anaphylaxis Severe | Hypersensitivity Dimethyl fumarate | Hypersensitivity Fumaric Acid Esters
Item
history of severe allergic or anaphylactic reactions, or known drug hypersensitivity to dimethyl fumarate (dmf) or fumaric acid esters.
boolean
C1527304 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0002792 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0058218 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C1959568 (UMLS CUI [4,2])
Mitoxantrone | Cyclophosphamide | rituximab
Item
prior treatment with any of the following medications within 12 months prior to randomization: mitoxantrone, cyclophosphamide, rituximab.
boolean
C0026259 (UMLS CUI [1])
C0010583 (UMLS CUI [2])
C0393022 (UMLS CUI [3])
fingolimod | teriflunomide | natalizumab | Cyclosporine | Azathioprine | Methotrexate | mycophenolate mofetil | laquinimod | Immunoglobulins, Intravenous | Plasmapheresis | Cytapheresis
Item
prior treatment with any of the following medications or procedures within 6 months prior to randomization: fingolimod, teriflunomide, natalizumab, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, laquinimod, intravenous (iv) immunoglobulin, plasmapheresis or cytapheresis.
boolean
C1699926 (UMLS CUI [1])
C1718383 (UMLS CUI [2])
C1172734 (UMLS CUI [3])
C0010592 (UMLS CUI [4])
C0004482 (UMLS CUI [5])
C0025677 (UMLS CUI [6])
C0209368 (UMLS CUI [7])
C1260208 (UMLS CUI [8])
C0085297 (UMLS CUI [9])
C0032134 (UMLS CUI [10])
C0079186 (UMLS CUI [11])
Eligibility Criteria Study Protocol
Item
note: other protocol defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])