Childbearing Potential Contraceptive methods
Item
subjects of childbearing potential must practice effective contraception from day -1 and be willing and able to continue contraception for duration of the study.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Multiple sclerosis relapse
Item
must have documented diagnosis of relapsing ms (mcdonald 2010 criteria [polman 2011]) at screening.
boolean
C0856120 (UMLS CUI [1])
Gilenya | BRACET | Biological Response Modifier Therapy Quantity | Natalizumab Previous
Item
must have been treated with gilenya or bracet for at least the 12 months prior to screening with no interruption of treatment greater than 1 month. more than 1 prior disease-modifying therapy is allowed, as long as minimum treatment duration was cumulatively 12 months. prior treatment with natalizumab is allowed; however, there must be a minimum 1 year since last natalizumab infusion and the screening visit of this study, and if discontinuation of natalizumab in the past was not due to intolerance, anti-natalizumab antibodies, or efficacy loss.
boolean
C2938762 (UMLS CUI [1])
C0909411 (UMLS CUI [2])
C0005527 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1172734 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
Gadolinium-Enhancing Lesion Quantity | Lesion T2 Quantity | Relapse | EDSS Elevated
Item
must have had disease activity in the 6 months prior to screening while on gilenya or bracet (as defined by at least 1 gd+ lesion or at least 2 new t2 lesions (compared with an mri done within 12 months of screening) or clinical relapse, or edss progression of 1 point)
boolean
C1333400 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C3472340 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0035020 (UMLS CUI [3])
C0451246 (UMLS CUI [4,1])
C3163633 (UMLS CUI [4,2])
EDSS
Item
must have an edss score from 0 to 5.5 inclusive at screening.
boolean
C0451246 (UMLS CUI [1])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
HIV Seropositivity
Item
history or positive test result at screening for human immunodeficiency virus (hiv).
boolean
C0019699 (UMLS CUI [1])
natalizumab
Item
prior treatment with natalizumab (either commercially or through a clinical study) within 1 year of day -1.
boolean
C1172734 (UMLS CUI [1])
Medical contraindication Natalizumab
Item
contraindications to treatment with natalizumab as described in the prescribing information for each of the participating countries.
boolean
C1301624 (UMLS CUI [1,1])
C1172734 (UMLS CUI [1,2])
Hypersensitivity Natalizumab | Hypersensitivity Natalizumab Ingredient | Natalizumab Ab Positive
Item
known allergy to natalizumab or any of its ingredients, or known to be anti-natalizumab antibody positive.
boolean
C0020517 (UMLS CUI [1,1])
C1172734 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1172734 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])
C1977362 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Progressive Relapsing
Item
diagnosis of primary progressive ms, secondary progressive ms, and/or progressive-relapsing ms.
boolean
C0751964 (UMLS CUI [1])
C0751965 (UMLS CUI [2])
C0393666 (UMLS CUI [3])
Multiple sclerosis relapse | Relapse Previous | Stabilization Lacking
Item
an ms relapse that has occurred within the 30 days prior to day -1 and/or the subject has not stabilized from a previous relapse prior to day -1.
boolean
C0856120 (UMLS CUI [1])
C0035020 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C1293130 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
Malignant Neoplasms | Exception Complete excision Basal cell carcinoma
Item
known active malignancies (subjects with cutaneous basal cell carcinoma that has been completely excised prior to study entry remain eligible).
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0015250 (UMLS CUI [2,2])
C0007117 (UMLS CUI [2,3])
Opportunistic Infections Severe | Leukoencephalopathy, Progressive Multifocal | Heart Disease | Endocrine System Diseases | Hematological Disease | Liver diseases | Immune System Diseases | Metabolic Diseases | Urologic Diseases | Lung diseases | Nervous system disorder | Dermatologic disorders | Mental disorders | Kidney Diseases | Disease Major
Item
history of severe opportunistic infections (including pml) or any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the investigator
boolean
C0029118 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0023524 (UMLS CUI [2])
C0018799 (UMLS CUI [3])
C0014130 (UMLS CUI [4])
C0018939 (UMLS CUI [5])
C0023895 (UMLS CUI [6])
C0021053 (UMLS CUI [7])
C0025517 (UMLS CUI [8])
C0042075 (UMLS CUI [9])
C0024115 (UMLS CUI [10])
C0027765 (UMLS CUI [11])
C0037274 (UMLS CUI [12])
C0004936 (UMLS CUI [13])
C0022658 (UMLS CUI [14])
C0012634 (UMLS CUI [15,1])
C0205164 (UMLS CUI [15,2])
Breast Feeding | Pregnancy | Pregnancy, Planned | Postmenopausal state Absent | Female Sterilization Absent | Gender Contraceptive methods Unwilling | Pregnancy test positive
Item
females breastfeeding, pregnant, or planning to become pregnant; women who are not post-menopausal or surgically sterile who are unwilling to practice contraception; women who have a positive pregnancy test result at day -1.
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0232970 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0015787 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0079399 (UMLS CUI [6,1])
C0700589 (UMLS CUI [6,2])
C0558080 (UMLS CUI [6,3])
C0240802 (UMLS CUI [7])
Immunosuppressive Agents | Mitoxantrone | Azathioprine | Methotrexate | Cyclophosphamide | MYCOPHENOLATE | Cladribine | rituximab | alemtuzumab
Item
prior history of immunosuppressant use (e.g., mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate, cladribine, rituximab) in the last 12 months prior to screening. prior history of alemtuzumab use at any point in the past.
boolean
C0021081 (UMLS CUI [1])
C0026259 (UMLS CUI [2])
C0004482 (UMLS CUI [3])
C0025677 (UMLS CUI [4])
C0010583 (UMLS CUI [5])
C0883242 (UMLS CUI [6])
C0092801 (UMLS CUI [7])
C0393022 (UMLS CUI [8])
C0383429 (UMLS CUI [9])
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])