ID

36494

Beschrijving

Observational Study to Assess the Correlation of EDSS With Quality of Life in MS Participants Treated With Natalizumab; ODM derived from: https://clinicaltrials.gov/show/NCT02386566

Link

https://clinicaltrials.gov/show/NCT02386566

Trefwoorden

Versies (1)
  1. 17-05-19 17-05-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

17 mei 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT02386566

Engels

Eligibility Multiple Sclerosis NCT02386566

1 Formulieren  
Criteria
Beschrijving

Criteria

subjects that have a confirmed diagnosis of rrms, as per the 2010 revised mcdonald criteria
Beschrijving

Multiple Sclerosis, Relapsing-Remitting

Datatype

boolean

Alias
UMLS CUI [1]
C0751967
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)
Beschrijving

Indication Natalizumab

Datatype

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1172734
decision for a treatment with natalizumab has been made before screening
Beschrijving

Decision Therapeutic procedure Natalizumab

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1172734
patients with an edss score of 2.0-5.5 (both limits inclusive)
Beschrijving

EDSS

Datatype

boolean

Alias
UMLS CUI [1]
C0451246
key exclusion criteria:
Beschrijving

Exclusion Criteria Main

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
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.
Beschrijving

Brain Disease Impact EDSS | Brain Disease Impact Quality of life | Exception Multiple Sclerosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006111
UMLS CUI [1,2]
C4049986
UMLS CUI [1,3]
C0451246
UMLS CUI [2,1]
C0006111
UMLS CUI [2,2]
C4049986
UMLS CUI [2,3]
C0518214
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0026769
pure spinal manifestation of demyelination
Beschrijving

Demyelination of spinal cord

Datatype

boolean

Alias
UMLS CUI [1]
C0586256
diagnosis of primary or secondary progressive ms
Beschrijving

Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive

Datatype

boolean

Alias
UMLS CUI [1]
C0751964
UMLS CUI [2]
C0751965
any change in concomitant medication known to affect cognition or bladder function
Beschrijving

Change of medication Affecting Cognitive function | Change of medication Affecting Bladder function

Datatype

boolean

Alias
UMLS CUI [1,1]
C0580105
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0009240
UMLS CUI [2,1]
C0580105
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0232840
a history of severe depressive disorder and/or suicidality, seizure, drug or alcohol abuse, as assessed by the investigator
Beschrijving

Depressive disorder Severe | Suicidality | Seizure | Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011581
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C3166387
UMLS CUI [3]
C0036572
UMLS CUI [4]
C0038586
note: other protocol defined inclusion/ exclusion criteria may apply.
Beschrijving

Eligibility Criteria Additional

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Multiple Sclerosis NCT02386566

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
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])
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