ID

25172

Description

Tysabri Observational Program; ODM derived from: https://clinicaltrials.gov/show/NCT00493298

Link

https://clinicaltrials.gov/show/NCT00493298

Keywords

Versions (1)
  1. 8/28/17 8/28/17 -
Uploaded on

August 28, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Relapsing-Remitting Multiple Sclerosis NCT00493298

English

Eligibility Relapsing-Remitting Multiple Sclerosis NCT00493298

1 forms  
Criteria
Description

Criteria

documented diagnosis of relapsing remitting multiple sclerosis
Description

Multiple Sclerosis, Relapsing-Remitting

Data type

boolean

Alias
UMLS CUI [1]
C0751967
the decision to treat with tysabri must precede enrollment
Description

Tysabri

Data type

boolean

Alias
UMLS CUI [1]
C1529600
patient must be a new tysabri user, and must not have had more than 3 tysabri infusions prior to enrollment
Description

Tysabri Use of Firstly | Tysabri Infusion Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1529600
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C1279901
UMLS CUI [2,1]
C1529600
UMLS CUI [2,2]
C0574032
UMLS CUI [2,3]
C1265611
must have had at least one relapse in the previous year, and must satisfy locally approved therapeutic indications for tysabri
Description

Relapse Quantity | Indication Tysabri

Data type

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C1529600
key exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
history of progressive multifocal leukoencephalopathy or other opportunistic infections, or an increased risk of opportunistic infections
Description

Leukoencephalopathy, Progressive Multifocal | Opportunistic Infections | Opportunistic Infections Risk Increased

Data type

boolean

Alias
UMLS CUI [1]
C0023524
UMLS CUI [2]
C0029118
UMLS CUI [3,1]
C0029118
UMLS CUI [3,2]
C0035647
UMLS CUI [3,3]
C0205217
history of positive anti-natalizumab antibodies
Description

Natalizumab Ab Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C1977362
UMLS CUI [1,2]
C1514241
concomitant immunomodulatory or immunosuppressive therapy during therapy with tysabri
Description

Immunomodulation | Therapeutic immunosuppression | Tysabri

Data type

boolean

Alias
UMLS CUI [1]
C1963758
UMLS CUI [2]
C0021079
UMLS CUI [3]
C1529600
patient immunocompromised at the time of enrollment
Description

Patient Immunocompromised

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0085393
known active malignancy
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
women must not be breast feeding or pregnant, or planning to become pregnant (must use birth control unless surgically sterile)
Description

Breast Feeding | Pregnancy | Pregnancy, Planned | Gender Contraceptive methods | Exception Female Sterilization

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0700589
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0015787
note: other protocol defined inclusion/exclusion criteria may apply.
Description

Clinical Trial Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Relapsing-Remitting Multiple Sclerosis NCT00493298

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Multiple Sclerosis, Relapsing-Remitting
Item
documented diagnosis of relapsing remitting multiple sclerosis
boolean
C0751967 (UMLS CUI [1])
Tysabri
Item
the decision to treat with tysabri must precede enrollment
boolean
C1529600 (UMLS CUI [1])
Tysabri Use of Firstly | Tysabri Infusion Quantity
Item
patient must be a new tysabri user, and must not have had more than 3 tysabri infusions prior to enrollment
boolean
C1529600 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C1279901 (UMLS CUI [1,3])
C1529600 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Relapse Quantity | Indication Tysabri
Item
must have had at least one relapse in the previous year, and must satisfy locally approved therapeutic indications for tysabri
boolean
C0035020 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C1529600 (UMLS CUI [2,2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Leukoencephalopathy, Progressive Multifocal | Opportunistic Infections | Opportunistic Infections Risk Increased
Item
history of progressive multifocal leukoencephalopathy or other opportunistic infections, or an increased risk of opportunistic infections
boolean
C0023524 (UMLS CUI [1])
C0029118 (UMLS CUI [2])
C0029118 (UMLS CUI [3,1])
C0035647 (UMLS CUI [3,2])
C0205217 (UMLS CUI [3,3])
Natalizumab Ab Positive
Item
history of positive anti-natalizumab antibodies
boolean
C1977362 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Immunomodulation | Therapeutic immunosuppression | Tysabri
Item
concomitant immunomodulatory or immunosuppressive therapy during therapy with tysabri
boolean
C1963758 (UMLS CUI [1])
C0021079 (UMLS CUI [2])
C1529600 (UMLS CUI [3])
Patient Immunocompromised
Item
patient immunocompromised at the time of enrollment
boolean
C0030705 (UMLS CUI [1,1])
C0085393 (UMLS CUI [1,2])
Malignant Neoplasms
Item
known active malignancy
boolean
C0006826 (UMLS CUI [1])
Breast Feeding | Pregnancy | Pregnancy, Planned | Gender Contraceptive methods | Exception Female Sterilization
Item
women must not be breast feeding or pregnant, or planning to become pregnant (must use birth control unless surgically sterile)
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0015787 (UMLS CUI [5,2])
Clinical Trial Eligibility Criteria Study Protocol
Item
note: other protocol defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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