ID

4961

Description

ODM derived from http://clinicaltrials.gov/show/NCT00420212

Link

http://clinicaltrials.gov/show/NCT00420212

Keywords

Versions (2)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/15/14 4/15/14 - Julian Varghese
Uploaded on

April 15, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00420212 Relapsing-remitting Multiple Sclerosis

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
Age 18 Years to 55 Years
Description

age 18 Years to 55 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:
Description

Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:

Data type

boolean

Alias
UMLS CUI 2011AA
C1548635
HL7 V3 2006_05
ELG
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C0013893
UMLS CUI 2011AA
CL414621
UMLS CUI 2011AA
C0439547
SNOMED CT 2011_0131
272105005
UMLS CUI 2011AA
C0034656
Aged 18 to 55 years old, inclusive, at the time of informed consent.
Description

Aged 18 to 55 years old, inclusive, at the time of informed consent.

Data type

boolean

Alias
UMLS CUI 2011AA
C0439547
SNOMED CT 2011_0131
272105005
UMLS CUI 2011AA
C0021430
Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
Description

Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.

Data type

boolean

Alias
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0751967
SNOMED CT 2011_0131
426373005
MedDRA 14.1
10063399
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0679228
UMLS CUI 2011AA
C0026769
SNOMED CT 2011_0131
24700007
MedDRA 14.1
10028245
LOINC Version 232
MTHU020805
ICD-10-CM Version 2010
G35
ICD-9-CM Version 2011
340
Must have a baseline EDSS <= 5.0, inclusive.
Description

Must have a baseline EDSS <= 5.0, inclusive.

Data type

boolean

Alias
UMLS CUI 2011AA
C1442488
UMLS CUI 2011AA
C0451246
SNOMED CT 2011_0131
273554001
Must have relapsing-remitting disease course.
Description

Must have relapsing-remitting disease course.

Data type

boolean

Alias
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C0439600
SNOMED CT 2011_0131
255319006
UMLS CUI 2011AA
C0242656
SNOMED CT 2011_0131
246453008
MedDRA 14.1
10061818
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at randomization:
Description

Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at randomization:

Data type

boolean

Alias
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
CL425201
UMLS CUI 2011AA
C0439547
SNOMED CT 2011_0131
272105005
UMLS CUI 2011AA
C0034656
Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
Description

Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C1290894
SNOMED CT 2011_0131
128299006
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C0205178
SNOMED CT 2011_0131
272118002
UMLS CUI 2011AA
C0042075
SNOMED CT 2011_0131
128606002
MedDRA 14.1
10046566
ICD-10-CM Version 2010
N39.9
ICD-9-CM Version 2011
599.9
UMLS CUI 2011AA
C0024115
SNOMED CT 2011_0131
19829001
MedDRA 14.1
10025082
ICD-10-CM Version 2010
J98.4
UMLS CUI 2011AA
C0017178
SNOMED CT 2011_0131
119292006
MedDRA 14.1
10017944
Pregnant or nursing women.
Description

Pregnant or nursing women.

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 18 Years to 55 Years
Item
Age 18 Years to 55 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:
Item
Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:
boolean
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0013893 (UMLS CUI 2011AA)
CL414621 (UMLS CUI 2011AA)
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Aged 18 to 55 years old, inclusive, at the time of informed consent.
Item
Aged 18 to 55 years old, inclusive, at the time of informed consent.
boolean
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C0021430 (UMLS CUI 2011AA)
Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
Item
Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
boolean
C0750484 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0751967 (UMLS CUI 2011AA)
426373005 (SNOMED CT 2011_0131)
10063399 (MedDRA 14.1)
C0680240 (UMLS CUI 2011AA)
C0679228 (UMLS CUI 2011AA)
C0026769 (UMLS CUI 2011AA)
24700007 (SNOMED CT 2011_0131)
10028245 (MedDRA 14.1)
MTHU020805 (LOINC Version 232)
G35 (ICD-10-CM Version 2010)
340 (ICD-9-CM Version 2011)
Must have a baseline EDSS <= 5.0, inclusive.
Item
Must have a baseline EDSS <= 5.0, inclusive.
boolean
C1442488 (UMLS CUI 2011AA)
C0451246 (UMLS CUI 2011AA)
273554001 (SNOMED CT 2011_0131)
Must have relapsing-remitting disease course.
Item
Must have relapsing-remitting disease course.
boolean
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C0439600 (UMLS CUI 2011AA)
255319006 (SNOMED CT 2011_0131)
C0242656 (UMLS CUI 2011AA)
246453008 (SNOMED CT 2011_0131)
10061818 (MedDRA 14.1)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at randomization:
Item
Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at randomization:
boolean
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
CL425201 (UMLS CUI 2011AA)
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
Item
Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C1290894 (UMLS CUI 2011AA)
128299006 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0042075 (UMLS CUI 2011AA)
128606002 (SNOMED CT 2011_0131)
10046566 (MedDRA 14.1)
N39.9 (ICD-10-CM Version 2010)
599.9 (ICD-9-CM Version 2011)
C0024115 (UMLS CUI 2011AA)
19829001 (SNOMED CT 2011_0131)
10025082 (MedDRA 14.1)
J98.4 (ICD-10-CM Version 2010)
C0017178 (UMLS CUI 2011AA)
119292006 (SNOMED CT 2011_0131)
10017944 (MedDRA 14.1)
Pregnant or nursing women.
Item
Pregnant or nursing women.
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
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