informed consent
Item
given written/signed informed consent
boolean
C0021430 (UMLS CUI [1])
age
Item
age 18 to 50 years old (inclusive) as of the date the informed consent form (icf) was signed
boolean
C0001779 (UMLS CUI [1])
multiple sclerosis, diagnosis criteria, mri brain
Item
diagnosis of ms per updated mcdonald criteria, and cranial magnetic resonance imaging (mri) scan demonstrating white matter lesions attributable to ms within 5 years of screening
boolean
C0026769 (UMLS CUI [1,1])
C0679228 (UMLS CUI [1,2])
C0024485 (UMLS CUI [2,1])
C2675929 (UMLS CUI [2,2])
onset of symptoms, multiple sclerosis
Item
onset of ms symptoms (as determined by a neurologist, either at screening or retrospectively) within 5 years of the date the icf was signed
boolean
C0277793 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
edss
Item
expanded disability status scale (edss) score 0.0 to 3.0 (inclusive) at screening
boolean
C0451246 (UMLS CUI [1])
ms attacks, quantity
Item
greater than or equal to (>=) 2 ms attacks (first episode or relapse) occurring in the 24 months prior to the date the icf was signed, with >=1 attack in the 12 months prior to the date the icf was signed, with objective neurological signs confirmed by a physician, nurse practitioner, or other genzyme-approved health-care provider and the objective signs could be identified retrospectively
boolean
C0856120 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
prior therapy alemtuzumab, interferons, intravenous immunoglobulin, glatiramer acetate, natalizumab, mitoxantrone
Item
received prior therapy for ms other than corticosteroids, for example, alemtuzumab, interferons, intravenous immunoglobulin, glatiramer acetate, natalizumab, and mitoxantrone
boolean
C1514463 (UMLS CUI [1,1])
C0383429 (UMLS CUI [1,2])
C0021747 (UMLS CUI [1,3])
C0085297 (UMLS CUI [1,4])
C0289884 (UMLS CUI [1,5])
C1172734 (UMLS CUI [1,6])
C0026259 (UMLS CUI [1,7])
C0149783 (UMLS CUI [2])
exposure to azathioprine, cladribine, cyclophosphamide, cyclosporine a, methotrexate, or any other immunosuppressive agent
Item
exposure to azathioprine, cladribine, cyclophosphamide, cyclosporine a, methotrexate, or any other immunosuppressive agent other than systemic corticosteroid treatment
boolean
C0332157 (UMLS CUI [1,1])
C0004482 (UMLS CUI [1,2])
C0092801 (UMLS CUI [1,3])
C0010583 (UMLS CUI [1,4])
C0010592 (UMLS CUI [1,5])
C0025677 (UMLS CUI [1,6])
C0021081 (UMLS CUI [1,7])
C0149783 (UMLS CUI [2])
progressive ms
Item
any progressive form of ms
boolean
C0751964 (UMLS CUI [1,1])
C0751965 (UMLS CUI [1,2])
history of malignancy, basal skin cell carcinoma
Item
history of malignancy (except basal skin cell carcinoma)
boolean
C2735088 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
cd4 + , cd8 + count, b cell, or absolute neutrophil count
Item
cd4 + , cd8 + count, b cell, or absolute neutrophil count less than (<) lower limit of normal (lln) at screening
boolean
C1277776 (UMLS CUI [1])
C1277777 (UMLS CUI [2])
C1303089 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
bleeding disorder, dysfibrinogenemia, factor ix deficiency, hemophilia, von willebrand's disease, disseminated intravascular coagulation, fibrinogen deficiency, clotting factor deficiency
Item
known bleeding disorder (for example, dysfibrinogenemia, factor ix deficiency, hemophilia, von willebrand's disease, disseminated intravascular coagulation, fibrinogen deficiency, or clotting factor deficiency)
boolean
C0005779 (UMLS CUI [1])
C1260903 (UMLS CUI [2])
C0008533 (UMLS CUI [3])
C0019069 (UMLS CUI [4])
C0042974 (UMLS CUI [5])
C0012739 (UMLS CUI [6])
C0553681 (UMLS CUI [7])
C0272315 (UMLS CUI [8])
autoimmune disease, immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, connective tissue disorders, vasculitis, inflammatory bowel disease, psoriasis
Item
significant autoimmune disease including but not limited to immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis
boolean
C0004364 (UMLS CUI [1])
C3274706 (UMLS CUI [2])
C0003873 (UMLS CUI [3])
C0024141 (UMLS CUI [4])
C0009782 (UMLS CUI [5])
C0042384 (UMLS CUI [6])
C0021390 (UMLS CUI [7])
C0033860 (UMLS CUI [8])
TSH receptor antibodies
Item
presence of anti-thyroid stimulating hormone (tsh) receptor (tshr) antibodies (that is, above the lln)
boolean
C0201514 (UMLS CUI [1])
active infection or at high risk for infection
Item
active infection or at high risk for infection
boolean
C0009450 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0332167 (UMLS CUI [2,1])
C0009450 (UMLS CUI [2,2])