Eligibility Relapsing-Remitting Multiple Sclerosis NCT01838668

Criteria
Description

Criteria

inclusion criteria for part i:
Description

Inclusion criteria Part Number

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0237753
must have a diagnosis of relapsing-remitting multiple sclerosis (rrms).
Description

Multiple Sclerosis, Relapsing-Remitting

Data type

boolean

Alias
UMLS CUI [1]
C0751967
must have a baseline expanded disability status scale (edss) score between 0.0 and 5.0, inclusive.
Description

EDSS

Data type

boolean

Alias
UMLS CUI [1]
C0451246
key inclusion criteria for part ii:
Description

Inclusion criteria Main Part Number

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1542147
UMLS CUI [1,3]
C0449719
UMLS CUI [1,4]
C0237753
• subjects who participated in and completed part i per protocol.
Description

Participation Clinical Trial Part Number | Clinical Trial Part Number Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0449719
UMLS CUI [1,4]
C0237753
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0449719
UMLS CUI [2,3]
C0237753
UMLS CUI [2,4]
C0205197
key exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
Description

Chronic disease of immune system | Malignant Neoplasms | Urologic Disease | Lung disease | Gastrointestinal Disease

Data type

boolean

Alias
UMLS CUI [1]
C1290894
UMLS CUI [2]
C0006826
UMLS CUI [3]
C0042075
UMLS CUI [4]
C0024115
UMLS CUI [5]
C0017178
pregnant or nursing women.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
note: other protocol-defined inclusion/exclusion criteria may apply.
Description

Eligibility Criteria Study Protocol

Data type

boolean

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

Similar models

Eligibility Relapsing-Remitting Multiple Sclerosis NCT01838668

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion criteria Part Number
Item
inclusion criteria for part i:
boolean
C1512693 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Multiple Sclerosis, Relapsing-Remitting
Item
must have a diagnosis of relapsing-remitting multiple sclerosis (rrms).
boolean
C0751967 (UMLS CUI [1])
EDSS
Item
must have a baseline expanded disability status scale (edss) score between 0.0 and 5.0, inclusive.
boolean
C0451246 (UMLS CUI [1])
Inclusion criteria Main Part Number
Item
key inclusion criteria for part ii:
boolean
C1512693 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C0449719 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
Participation Clinical Trial Part Number | Clinical Trial Part Number Completed
Item
• subjects who participated in and completed part i per protocol.
boolean
C0679823 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0449719 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
C0008976 (UMLS CUI [2,1])
C0449719 (UMLS CUI [2,2])
C0237753 (UMLS CUI [2,3])
C0205197 (UMLS CUI [2,4])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Chronic disease of immune system | Malignant Neoplasms | Urologic Disease | Lung disease | Gastrointestinal Disease
Item
other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
boolean
C1290894 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C0042075 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0017178 (UMLS CUI [5])
Pregnancy | Breast Feeding
Item
pregnant or nursing women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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])