Multiple Sclerosis
Item
definite ms diagnosis according to mcdonald's criteria;
boolean
C0026769 (UMLS CUI [1])
Clinical course Relapsing | Disease Progression | Disease Progression Absent
Item
relapsing clinical course, with or without progression;
boolean
C0449259 (UMLS CUI [1,1])
C0035020 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
C0242656 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
EDSS Ambulatory
Item
expanded disability status scale [edss] less or equal to 5.5 (ambulatory);
boolean
C0451246 (UMLS CUI [1,1])
C0439841 (UMLS CUI [1,2])
Glatiramer acetate Dosage Stable
Item
stable dose of glatiramer acetate [ga] for at least 26 weeks prior to the screening visit;
boolean
C0289884 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Absence Onset of Multiple sclerosis relapse
Item
no onset of ms relapse in the preceding 60 days prior to randomization;
boolean
C0332197 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C0856120 (UMLS CUI [1,3])
Stable status Clinical
Item
clinically stable for 4 weeks prior to randomization.
boolean
C0205360 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
Chronic disease of immune system | Liver Dysfunction | Pancreatic Disease chronic
Item
other chronic disease of the immune system, liver function impairment or chronic pancreatic disease;
boolean
C1290894 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
C0030286 (UMLS CUI [3,1])
C0205191 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
pregnant or nursing woman;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Substance Use Disorders
Item
alcohol or drug abuse;
boolean
C0038586 (UMLS CUI [1])
Cladribine | Mitoxantrone | Immunosuppressive Agents | Azathioprine | Cyclophosphamide | Cyclosporine | Methotrexate | MYCOPHENOLATE
Item
use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment;
boolean
C0092801 (UMLS CUI [1])
C0026259 (UMLS CUI [2])
C0021081 (UMLS CUI [3])
C0004482 (UMLS CUI [4])
C0010583 (UMLS CUI [5])
C0010592 (UMLS CUI [6])
C0025677 (UMLS CUI [7])
C0883242 (UMLS CUI [8])
HIV Seropositivity
Item
human immunodeficiency virus [hiv] positive status;
boolean
C0019699 (UMLS CUI [1])
Condition Preventing Compliance behavior | Condition Preventing Completion of clinical trial
Item
any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study.
boolean
C0348080 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
Eligibility Criteria Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C1516637 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])