Eligibility NCT00420212 Relapsing-remitting Multiple Sclerosis
ODM derived from http://clinicaltrials.gov/show/NCT00420212

Eligibility

  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)