ID

5027

Description

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

Link

http://clinicaltrials.gov/show/NCT00879658

Keywords

Versions (3)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/16/14 4/16/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

April 16, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00879658 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
Diagnosis of Multiple Sclerosis (MS) as defined by revised McDonald criteria.
Description

Diagnosis of Multiple Sclerosis (MS) as defined by revised McDonald criteria.

Data type

boolean

Alias
UMLS CUI 1
C0011900
UMLS CUI 1*2
C0026769
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.)
Description

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.)

Data type

boolean

Alias
UMLS CUI 2011AA
C0751967
SNOMED CT 2011_0131
426373005
MedDRA 14.1
10063399
UMLS CUI 2011AA
C0855567
MedDRA 14.1
10029821
UMLS CUI 2011AA
C1409616
An Expanded Disability Status Scale (EDSS) score of 0-5.0 inclusive at randomization.
Description

An Expanded Disability Status Scale (EDSS) score of 0-5.0 inclusive at randomization.

Data type

boolean

Alias
UMLS CUI 2011AA
C0451246
SNOMED CT 2011_0131
273554001
UMLS CUI 2011AA
C0034656
Neurologically stable with no evidence of relapse or corticosteroid treatment within 30 days prior to randomization.
Description

Neurologically stable with no evidence of relapse or corticosteroid treatment within 30 days prior to randomization.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205494
SNOMED CT 2011_0131
1199008
LOINC Version 232
MTHU031871
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0332125
SNOMED CT 2011_0131
41647002
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C0149783
SNOMED CT 2011_0131
297279009
MedDRA 14.1
10062117
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
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.
Description

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.

Data type

boolean

Alias
UMLS CUI 2011AA
C2733540
SNOMED CT 2011_0131
443390004
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0470187
SNOMED CT 2011_0131
103328004
UMLS CUI 2011AA
C0013227
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
UMLS CUI 2011AA
C1522154
UMLS CUI 2011AA
C0524785
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
A manifestation of another type of MS than RRMS
Description

A manifestation of another type of MS than RRMS

Data type

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0332307
SNOMED CT 2011_0131
410657003
LOINC Version 232
MTHU013727
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
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0751967
SNOMED CT 2011_0131
426373005
MedDRA 14.1
10063399
History of chronic disease of the immune system other than MS
Description

History of chronic disease of the immune system other than MS

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C1290894
SNOMED CT 2011_0131
128299006
UMLS CUI 2011AA
CL411789
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
Malignancies, diabetes, significant cardiovascular, pulmonary and hepatic diseases and conditions
Description

Malignancies, diabetes, significant cardiovascular, pulmonary and hepatic diseases and conditions

Data type

boolean

Alias
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
C0011849
SNOMED CT 2011_0131
191044006
UMLS CUI 2011AA
C0007222
SNOMED CT 2011_0131
105980002
MedDRA 14.1
10007649
ICD-9-CM Version 2011
429.2
UMLS CUI 2011AA
C0024115
SNOMED CT 2011_0131
19829001
MedDRA 14.1
10025082
ICD-10-CM Version 2010
J98.4
UMLS CUI 2011AA
C0023895
SNOMED CT 2011_0131
235856003
MedDRA 14.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
Active infections
Description

Active infections

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0021311
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
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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)
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
C2733540 (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)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
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