ID

22396

Description

A Canadian Study Assessing the Utility of the Treatment Optimization Recommendations in Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT01142583

Lien

https://clinicaltrials.gov/show/NCT01142583

Mots-clés

Versions (1)
  1. 01/06/2017 01/06/2017 -
Téléchargé le

1 juin 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis, Relapsing-Remitting NCT01142583

Anglais

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT01142583

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with duration of rrms or cis ≤ 10 yr from onset of symptoms.
Description

rrms or cis duration

Type de données

boolean

Alias
UMLS CUI [1,1]
C0751967
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C2921627
UMLS CUI [2,2]
C0449238
subjects aged between 18 and 55 years
Description

age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
subjects with edss score of 0 to ≤ 4.0
Description

edss

Type de données

boolean

Alias
UMLS CUI [1]
C0451246
subjects on consistent therapy with a single dmd (avonex®, betaseron®, copaxone®, rebif®) for at least 12 months.
Description

avonex®, betaseron®, copaxone®, rebif®

Type de données

boolean

Alias
UMLS CUI [1]
C0594372
UMLS CUI [2]
C0284968
UMLS CUI [3]
C0528175
UMLS CUI [4]
C0752980
subjects whose relapse data over the last 12 months was available in the subject's chart
Description

multiple sclerosis relapse, data available

Type de données

boolean

Alias
UMLS CUI [1,1]
C0856120
UMLS CUI [1,2]
C4035953
subjects whose edss data over the last 12 months was available in the subject's chart
Description

edss, data available

Type de données

boolean

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C4035953
subjects who were eligible to receive any of the 4 dmds
Description

eligible to receive dmds

Type de données

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C0242708
consecutive subjects were screened until 10 eligible subjects were enrolled (to minimize any selection bias) - subject was therefore one of 10 consecutive eligible, consenting subjects
Description

consecutive eligible

Type de données

boolean

Alias
UMLS CUI [1,1]
C1707491
UMLS CUI [1,2]
C1548635
subjects who had given written informed consent with the understanding that the subject could withdraw consent at any time without prejudice to future medical care
Description

informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject who was not expected to be followed reliably over the next 12 months
Description

reliable follow-up

Type de données

boolean

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C1321605
subjects with concomitant participation in any other studies involving investigational or marketed products
Description

study subject participation status

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
subject wo had previously failed dmd therapy and/or switched between therapies
Description

previously failed dmd therapy, switch between therapies

Type de données

boolean

Alias
UMLS CUI [1,1]
C0919875
UMLS CUI [1,2]
C0242708
UMLS CUI [2]
C3665894
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Similar models

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT01142583

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
rrms or cis duration
Item
subjects with duration of rrms or cis ≤ 10 yr from onset of symptoms.
boolean
C0751967 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C2921627 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
age
Item
subjects aged between 18 and 55 years
boolean
C0001779 (UMLS CUI [1])
edss
Item
subjects with edss score of 0 to ≤ 4.0
boolean
C0451246 (UMLS CUI [1])
avonex®, betaseron®, copaxone®, rebif®
Item
subjects on consistent therapy with a single dmd (avonex®, betaseron®, copaxone®, rebif®) for at least 12 months.
boolean
C0594372 (UMLS CUI [1])
C0284968 (UMLS CUI [2])
C0528175 (UMLS CUI [3])
C0752980 (UMLS CUI [4])
multiple sclerosis relapse, data available
Item
subjects whose relapse data over the last 12 months was available in the subject's chart
boolean
C0856120 (UMLS CUI [1,1])
C4035953 (UMLS CUI [1,2])
edss, data available
Item
subjects whose edss data over the last 12 months was available in the subject's chart
boolean
C0451246 (UMLS CUI [1,1])
C4035953 (UMLS CUI [1,2])
eligible to receive dmds
Item
subjects who were eligible to receive any of the 4 dmds
boolean
C1548635 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0242708 (UMLS CUI [1,3])
consecutive eligible
Item
consecutive subjects were screened until 10 eligible subjects were enrolled (to minimize any selection bias) - subject was therefore one of 10 consecutive eligible, consenting subjects
boolean
C1707491 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
informed consent
Item
subjects who had given written informed consent with the understanding that the subject could withdraw consent at any time without prejudice to future medical care
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
reliable follow-up
Item
subject who was not expected to be followed reliably over the next 12 months
boolean
C1522577 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
study subject participation status
Item
subjects with concomitant participation in any other studies involving investigational or marketed products
boolean
C2348568 (UMLS CUI [1])
previously failed dmd therapy, switch between therapies
Item
subject wo had previously failed dmd therapy and/or switched between therapies
boolean
C0919875 (UMLS CUI [1,1])
C0242708 (UMLS CUI [1,2])
C3665894 (UMLS CUI [2])
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