Multiple Sclerosis, Relapsing-Remitting
Item
subjects that have a confirmed diagnosis of rrms, as per the 2010 revised mcdonald criteria
boolean
C0751967 (UMLS CUI [1])
Indication Natalizumab
Item
subjects satisfying the therapeutic indication of natalizumab, as described in the local product label and confirmed by the investigator. (patients with previous treatment with natalizumab are also considered to be eligible only if the last natalizumab infusion was at least 1 year before the screening visit of this study)
boolean
C3146298 (UMLS CUI [1,1])
C1172734 (UMLS CUI [1,2])
Decision Therapeutic procedure Natalizumab
Item
decision for a treatment with natalizumab has been made before screening
boolean
C0679006 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1172734 (UMLS CUI [1,3])
EDSS
Item
patients with an edss score of 2.0-5.5 (both limits inclusive)
boolean
C0451246 (UMLS CUI [1])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Brain Disease Impact EDSS | Brain Disease Impact Quality of life | Exception Multiple Sclerosis
Item
patients with a diagnosed co-existing brain pathology other than ms, which in the judgement of the investigator impacts the value of edss or qol.
boolean
C0006111 (UMLS CUI [1,1])
C4049986 (UMLS CUI [1,2])
C0451246 (UMLS CUI [1,3])
C0006111 (UMLS CUI [2,1])
C4049986 (UMLS CUI [2,2])
C0518214 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0026769 (UMLS CUI [3,2])
Demyelination of spinal cord
Item
pure spinal manifestation of demyelination
boolean
C0586256 (UMLS CUI [1])
Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive
Item
diagnosis of primary or secondary progressive ms
boolean
C0751964 (UMLS CUI [1])
C0751965 (UMLS CUI [2])
Change of medication Affecting Cognitive function | Change of medication Affecting Bladder function
Item
any change in concomitant medication known to affect cognition or bladder function
boolean
C0580105 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0009240 (UMLS CUI [1,3])
C0580105 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0232840 (UMLS CUI [2,3])
Depressive disorder Severe | Suicidality | Seizure | Substance Use Disorders
Item
a history of severe depressive disorder and/or suicidality, seizure, drug or alcohol abuse, as assessed by the investigator
boolean
C0011581 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3166387 (UMLS CUI [2])
C0036572 (UMLS CUI [3])
C0038586 (UMLS CUI [4])
Eligibility Criteria Additional
Item
note: other protocol defined inclusion/ exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])