Eligibility NCT00879658 Relapsing-remitting Multiple Sclerosis

ODM derived from http://clinicaltrials.gov/show/NCT00879658

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)
Diagnosis of Multiple Sclerosis (MS) as defined by revised McDonald criteria.
Item
Diagnosis of Multiple Sclerosis (MS) as defined by revised McDonald criteria.
boolean
C0011900 (UMLS CUI 1)
C0026769 (UMLS CUI 1*2)
A relapsing-remitting course of disease with at least 1 documented relapse during the previous year, or 2 documented relapses during the previous 2 years, or a positive gadolinium (Gd)-enhanced MRI scan at screening (in case the first MRI scan obtained at screening is negative, a second scan may be obtained 1 month later.)
Item
A relapsing-remitting course of disease with at least 1 documented relapse during the previous year, or 2 documented relapses during the previous 2 years, or a positive gadolinium (Gd)-enhanced MRI scan at screening (in case the first MRI scan obtained at screening is negative, a second scan may be obtained 1 month later.)
boolean
C0751967 (UMLS CUI 2011AA)
426373005 (SNOMED CT 2011_0131)
10063399 (MedDRA 14.1)
C0855567 (UMLS CUI 2011AA)
10029821 (MedDRA 14.1)
C1409616 (UMLS CUI 2011AA)
An Expanded Disability Status Scale (EDSS) score of 0-5.0 inclusive at randomization.
Item
An Expanded Disability Status Scale (EDSS) score of 0-5.0 inclusive at randomization.
boolean
C0451246 (UMLS CUI 2011AA)
273554001 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Neurologically stable with no evidence of relapse or corticosteroid treatment within 30 days prior to randomization.
Item
Neurologically stable with no evidence of relapse or corticosteroid treatment within 30 days prior to randomization.
boolean
C0205494 (UMLS CUI 2011AA)
1199008 (SNOMED CT 2011_0131)
MTHU031871 (LOINC Version 232)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0332125 (UMLS CUI 2011AA)
41647002 (SNOMED CT 2011_0131)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C0149783 (UMLS CUI 2011AA)
297279009 (SNOMED CT 2011_0131)
10062117 (MedDRA 14.1)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Patients who decline initiation or continuation of treatment with available disease modifying drugs for MS, for whatever reason, after having been informed about their respective benefits and possible adverse events by the investigator.
Item
Patients who decline initiation or continuation of treatment with available disease modifying drugs for MS, for whatever reason, after having been informed about their respective benefits and possible adverse events by the investigator.
boolean
C1705116 (UMLS CUI 2011AA)
443390004 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0470187 (UMLS CUI 2011AA)
103328004 (SNOMED CT 2011_0131)
C0013227 (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)
C1522154 (UMLS CUI 2011AA)
C0524785 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
A manifestation of another type of MS than RRMS
Item
A manifestation of another type of MS than RRMS
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0332307 (UMLS CUI 2011AA)
410657003 (SNOMED CT 2011_0131)
MTHU013727 (LOINC Version 232)
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)
CL411789 (UMLS CUI 2011AA)
C0751967 (UMLS CUI 2011AA)
426373005 (SNOMED CT 2011_0131)
10063399 (MedDRA 14.1)
History of chronic disease of the immune system other than MS
Item
History of chronic disease of the immune system other than MS
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1290894 (UMLS CUI 2011AA)
128299006 (SNOMED CT 2011_0131)
CL411789 (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)
Malignancies, diabetes, significant cardiovascular, pulmonary and hepatic diseases and conditions
Item
Malignancies, diabetes, significant cardiovascular, pulmonary and hepatic diseases and conditions
boolean
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (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)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
Active infections
Item
Active infections
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)

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