ID

43297

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT01194570

Link

http://clinicaltrials.gov/show/NCT01194570

Stichworte

Versionen (2)
  1. 19.03.13 19.03.13 - Martin Dugas
  2. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility NCT01194570 Multiple Sclerosis, Primary Progressive

Deutsch Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Beschreibung

Inclusion Criteria

age 18 Years to 55 Years
Beschreibung

age 18 Years to 55 Years

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Adult (person)
Beschreibung

Adult patients, 18-55 years of age

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0001675
SNOMED CT 2011_0131
133936004
Primary Progressive Multiple Sclerosis (according to revised McDonald criteria)
Beschreibung

Primary Progressive Multiple Sclerosis (according to revised McDonald criteria)

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0751964
SNOMED CT 2011_0131
428700003
MedDRA 14.1
10063401
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
CL414621
EDSS - Expanded disability status scale 3-6.5
Beschreibung

Expanded Disability Status Scale (EDSS) 3 to 6.5 points

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0451246
SNOMED CT 2011_0131
273554001
Disease duration from onset of MS symptoms < 15 years if EDSS > 5.0, < 10 years if EDSS >/= 5.0
Beschreibung

Disease duration from onset of MS symptoms < 15 years if EDSS > 5.0, < 10 years if EDSS >/= 5.0

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0872146
UMLS CUI 2011AA
C1711239
UMLS CUI 2011AA
C0332162
SNOMED CT 2011_0131
77374008
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
C1457887
LOINC Version 232
MTHU021540
ICD-9-CM Version 2011
780-789.99
Sexually active male and female patients of reproductive potential must use two methods of contraception throughout the study treatment phase and for 48 weeks after the last dose
Beschreibung

Sexually active male and female patients of reproductive potential must use two methods of contraception throughout the study treatment phase and for 48 weeks after the last dose

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0241028
SNOMED CT 2011_0131
228453005
MedDRA 14.1
10066098
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0035150
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0025663
SNOMED CT 2011_0131
260686004
LOINC Version 232
MTHU024654
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Exclusion Criteria
Beschreibung

Exclusion Criteria

History of relapsing remitting multiple sclerosis, secondary progressive, or progressive relapsing multiple sclerosis at screening
Beschreibung

History of relapsing remitting multiple sclerosis, secondary progressive, or progressive relapsing multiple sclerosis at screening

Datentyp

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0751967
SNOMED CT 2011_0131
426373005
MedDRA 14.1
10063399
UMLS CUI 2011AA
C0751965
SNOMED CT 2011_0131
425500002
MedDRA 14.1
10063400
UMLS CUI 2011AA
C0393666
SNOMED CT 2011_0131
230374002
MedDRA 14.1
10067063
UMLS CUI 2011AA
C1409616
Contraindications for Magnetic Resonance Imaging (MRI)
Beschreibung

Contraindications for Magnetic Resonance Imaging (MRI)

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C0024485
SNOMED CT 2011_0131
113091000
MedDRA 14.1
10028049
Known presence of other neurologic disorders
Beschreibung

Known presence of other neurologic disorders

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0027765
SNOMED CT 2011_0131
118940003
MedDRA 14.1
10029202
ICD-10-CM Version 2010
G98.8
ICD-9-CM Version 2011
349.9
Known active infection or history of or presence of recurrent or chronic infection
Beschreibung

Known active infection or history of or presence of recurrent or chronic infection

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0239998
MedDRA 14.1
10067860
History of cancer, including solid tumors and hematological malignancies (except for basal cell, in situ squamous cell carcinomas of the skin and in situ carcinoma of the cervix that have been excised and resolved)
Beschreibung

History of cancer, including solid tumors and hematological malignancies (except for basal cell, in situ squamous cell carcinomas of the skin and in situ carcinoma of the cervix that have been excised and resolved)

Datentyp

boolean

Alias
UMLS CUI 2011AA
C2735088
LOINC Version 232
MTHU034770
UMLS CUI 2011AA
C0280100
MedDRA 14.1
10065252
UMLS CUI 2011AA
C0376545
SNOMED CT 2011_0131
129154003
MedDRA 14.1
10066476
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0007117
SNOMED CT 2011_0131
1338007, 254701007
MedDRA 14.1
10004146
UMLS CUI 2011AA
C0334245
SNOMED CT 2011_0131
59529006
MedDRA 14.1
10022782
UMLS CUI 2011AA
C0851140
SNOMED CT 2011_0131
92564006
MedDRA 14.1
10061809
ICD-10-CM Version 2010
D06.9
ICD-9-CM Version 2011
233.1
UMLS CUI 2011AA
C0728940
SNOMED CT 2011_0131
65801008
UMLS CUI 2011AA
C1514893
Previous treatment with B-cell targeted therapies (e.g. rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
Beschreibung

Previous treatment with B-cell targeted therapies (e.g. rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0004561
SNOMED CT 2011_0131
112130006
LOINC Version 232
MTHU002435
UMLS CUI 2011AA
CL421608
UMLS CUI 2011AA
C0732355
SNOMED CT 2011_0131
386919002
UMLS CUI 2011AA
C1882138
UMLS CUI 2011AA
C2351058
UMLS CUI 2011AA
C1723401
SNOMED CT 2011_0131
449043000
UMLS CUI 2011AA
C1832027
SNOMED CT 2011_0131
444609007
Any previous treatment with lymphocyte trafficking blockers, with alemtuzumab, anti-CD4, cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation
Beschreibung

Any previous treatment with lymphocyte trafficking blockers, with alemtuzumab, anti-CD4, cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0024264
SNOMED CT 2011_0131
56972008
MedDRA 14.1
10025263
LOINC Version 232
MTHU004645
UMLS CUI 2011AA
C0599896
UMLS CUI 2011AA
C0243077
UMLS CUI 2011AA
C0383429
SNOMED CT 2011_0131
391864003
UMLS CUI 2011AA
C0003250
SNOMED CT 2011_0131
49616005
UMLS CUI 2011AA
C0521124
SNOMED CT 2011_0131
65897001
UMLS CUI 2011AA
C1332714
UMLS CUI 2011AA
C0092801
SNOMED CT 2011_0131
386916009
UMLS CUI 2011AA
C0010583
SNOMED CT 2011_0131
387420009
LOINC Version 232
MTHU029970
UMLS CUI 2011AA
C0026259
SNOMED CT 2011_0131
386913001
UMLS CUI 2011AA
C0004482
SNOMED CT 2011_0131
372574004
LOINC Version 232
MTHU006794
UMLS CUI 2011AA
C0209368
SNOMED CT 2011_0131
386976000
UMLS CUI 2011AA
C0010592
SNOMED CT 2011_0131
387467008
LOINC Version 232
MTHU005140
UMLS CUI 2011AA
C0025677
SNOMED CT 2011_0131
387381009
LOINC Version 232
MTHU005020
UMLS CUI 2011AA
C0043162
SNOMED CT 2011_0131
47479005
UMLS CUI 2011AA
C0005961
SNOMED CT 2011_0131
23719005
MedDRA 14.1
10061730
ICD-9-CM Version 2011
41.00
Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
Beschreibung

Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0243087
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UMLS CUI 2011AA
C0021081
SNOMED CT 2011_0131
372823004, 69431002
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion Criteria
age 18 Years to 55 Years
Item
age 18 Years to 55 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Adult patients, 18-55 years of age
Item
Adult (person)
boolean
C0001675 (UMLS CUI 2011AA)
133936004 (SNOMED CT 2011_0131)
Primary Progressive Multiple Sclerosis (according to revised McDonald criteria)
Item
Primary Progressive Multiple Sclerosis (according to revised McDonald criteria)
boolean
C0751964 (UMLS CUI 2011AA)
428700003 (SNOMED CT 2011_0131)
10063401 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
Expanded Disability Status Scale (EDSS) 3 to 6.5 points
Item
EDSS - Expanded disability status scale 3-6.5
boolean
C0451246 (UMLS CUI 2011AA)
273554001 (SNOMED CT 2011_0131)
Disease duration from onset of MS symptoms < 15 years if EDSS > 5.0, < 10 years if EDSS >/= 5.0
Item
Disease duration from onset of MS symptoms < 15 years if EDSS > 5.0, < 10 years if EDSS >/= 5.0
boolean
C0872146 (UMLS CUI 2011AA)
C1711239 (UMLS CUI 2011AA)
C0332162 (UMLS CUI 2011AA)
77374008 (SNOMED CT 2011_0131)
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)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
Sexually active male and female patients of reproductive potential must use two methods of contraception throughout the study treatment phase and for 48 weeks after the last dose
Item
Sexually active male and female patients of reproductive potential must use two methods of contraception throughout the study treatment phase and for 48 weeks after the last dose
boolean
C0241028 (UMLS CUI 2011AA)
228453005 (SNOMED CT 2011_0131)
10066098 (MedDRA 14.1)
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0035150 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0025663 (UMLS CUI 2011AA)
260686004 (SNOMED CT 2011_0131)
MTHU024654 (LOINC Version 232)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Item Group
Exclusion Criteria
History of relapsing remitting multiple sclerosis, secondary progressive, or progressive relapsing multiple sclerosis at screening
Item
History of relapsing remitting multiple sclerosis, secondary progressive, or progressive relapsing multiple sclerosis at screening
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0751967 (UMLS CUI 2011AA)
426373005 (SNOMED CT 2011_0131)
10063399 (MedDRA 14.1)
C0751965 (UMLS CUI 2011AA)
425500002 (SNOMED CT 2011_0131)
10063400 (MedDRA 14.1)
C0393666 (UMLS CUI 2011AA)
230374002 (SNOMED CT 2011_0131)
10067063 (MedDRA 14.1)
C1409616 (UMLS CUI 2011AA)
Contraindications for Magnetic Resonance Imaging (MRI)
Item
Contraindications for Magnetic Resonance Imaging (MRI)
boolean
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0024485 (UMLS CUI 2011AA)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
Known presence of other neurologic disorders
Item
Known presence of other neurologic disorders
boolean
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0027765 (UMLS CUI 2011AA)
118940003 (SNOMED CT 2011_0131)
10029202 (MedDRA 14.1)
G98.8 (ICD-10-CM Version 2010)
349.9 (ICD-9-CM Version 2011)
Known active infection or history of or presence of recurrent or chronic infection
Item
Known active infection or history of or presence of recurrent or chronic infection
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0239998 (UMLS CUI 2011AA)
10067860 (MedDRA 14.1)
History of cancer, including solid tumors and hematological malignancies (except for basal cell, in situ squamous cell carcinomas of the skin and in situ carcinoma of the cervix that have been excised and resolved)
Item
History of cancer, including solid tumors and hematological malignancies (except for basal cell, in situ squamous cell carcinomas of the skin and in situ carcinoma of the cervix that have been excised and resolved)
boolean
C2735088 (UMLS CUI 2011AA)
MTHU034770 (LOINC Version 232)
C0280100 (UMLS CUI 2011AA)
10065252 (MedDRA 14.1)
C0376545 (UMLS CUI 2011AA)
129154003 (SNOMED CT 2011_0131)
10066476 (MedDRA 14.1)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0007117 (UMLS CUI 2011AA)
1338007, 254701007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0334245 (UMLS CUI 2011AA)
59529006 (SNOMED CT 2011_0131)
10022782 (MedDRA 14.1)
C0851140 (UMLS CUI 2011AA)
92564006 (SNOMED CT 2011_0131)
10061809 (MedDRA 14.1)
D06.9 (ICD-10-CM Version 2010)
233.1 (ICD-9-CM Version 2011)
C0728940 (UMLS CUI 2011AA)
65801008 (SNOMED CT 2011_0131)
C1514893 (UMLS CUI 2011AA)
Previous treatment with B-cell targeted therapies (e.g. rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
Item
Previous treatment with B-cell targeted therapies (e.g. rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
boolean
C1514463 (UMLS CUI 2011AA)
C0004561 (UMLS CUI 2011AA)
112130006 (SNOMED CT 2011_0131)
MTHU002435 (LOINC Version 232)
CL421608 (UMLS CUI 2011AA)
C0732355 (UMLS CUI 2011AA)
386919002 (SNOMED CT 2011_0131)
C1882138 (UMLS CUI 2011AA)
C2351058 (UMLS CUI 2011AA)
C1723401 (UMLS CUI 2011AA)
449043000 (SNOMED CT 2011_0131)
C1832027 (UMLS CUI 2011AA)
444609007 (SNOMED CT 2011_0131)
Any previous treatment with lymphocyte trafficking blockers, with alemtuzumab, anti-CD4, cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation
Item
Any previous treatment with lymphocyte trafficking blockers, with alemtuzumab, anti-CD4, cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation
boolean
C1514463 (UMLS CUI 2011AA)
C0024264 (UMLS CUI 2011AA)
56972008 (SNOMED CT 2011_0131)
10025263 (MedDRA 14.1)
MTHU004645 (LOINC Version 232)
C0599896 (UMLS CUI 2011AA)
C0243077 (UMLS CUI 2011AA)
C0383429 (UMLS CUI 2011AA)
391864003 (SNOMED CT 2011_0131)
C0003250 (UMLS CUI 2011AA)
49616005 (SNOMED CT 2011_0131)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
C1332714 (UMLS CUI 2011AA)
C0092801 (UMLS CUI 2011AA)
386916009 (SNOMED CT 2011_0131)
C0010583 (UMLS CUI 2011AA)
387420009 (SNOMED CT 2011_0131)
MTHU029970 (LOINC Version 232)
C0026259 (UMLS CUI 2011AA)
386913001 (SNOMED CT 2011_0131)
C0004482 (UMLS CUI 2011AA)
372574004 (SNOMED CT 2011_0131)
MTHU006794 (LOINC Version 232)
C0209368 (UMLS CUI 2011AA)
386976000 (SNOMED CT 2011_0131)
C0010592 (UMLS CUI 2011AA)
387467008 (SNOMED CT 2011_0131)
MTHU005140 (LOINC Version 232)
C0025677 (UMLS CUI 2011AA)
387381009 (SNOMED CT 2011_0131)
MTHU005020 (LOINC Version 232)
C0043162 (UMLS CUI 2011AA)
47479005 (SNOMED CT 2011_0131)
C0005961 (UMLS CUI 2011AA)
23719005 (SNOMED CT 2011_0131)
10061730 (MedDRA 14.1)
41.00 (ICD-9-CM Version 2011)
Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
Item
Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
boolean
C0243087 (UMLS CUI 2011AA)
C1514873 (UMLS CUI 2011AA)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0021081 (UMLS CUI 2011AA)
372823004, 69431002 (SNOMED CT 2011_0131)
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