ID

43316

Description

ODM derived from http://clinicaltrials.gov/show/NCT01369342

Link

http://clinicaltrials.gov/show/NCT01369342

Keywords

Versions (2)
  1. 4/11/13 4/11/13 - Martin Dugas
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility NCT01369342 Crohn's Disease

German English

Eligibility

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

Inclusion Criteria

age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Have Crohn's disease of at least 3 months' duration with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, or endoscopy
Description

Have Crohn's disease of at least 3 months' duration with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, or endoscopy

Data type

boolean

Alias
UMLS CUI 2011AA
C0010346
SNOMED CT 2011_0131
34000006
MedDRA 14.1
10011401
ICD-10-CM Version 2010
K50.9
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0009319
SNOMED CT 2011_0131
64226004
MedDRA 14.1
10009887
ICD-10-CM Version 2010
K52.9
CTCAE 1105E
E10521
UMLS CUI 2011AA
C0020877
SNOMED CT 2011_0131
52457000
MedDRA 14.1
10021312
ICD-10-CM Version 2010
K52.9
UMLS CUI 2011AA
C0949272
MedDRA 14.1
10062647
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0043299
SNOMED CT 2011_0131
363680008
ICD-9-CM Version 2011
87
UMLS CUI 2011AA
C0344441
MedDRA 14.1
10062005
LOINC Version 232
MTHU010496
UMLS CUI 2011AA
C0014245
SNOMED CT 2011_0131
423827005
MedDRA 14.1
10014805
LOINC Version 232
MTHU008659
Have active Crohn's disease, defined as a baseline Crohn Disease Activity Index (CDAI) score of >= 220 and <= 450, with confirmation of active inflammation
Description

Have active Crohn's disease, defined as a baseline Crohn Disease Activity Index (CDAI) score of >= 220 and <= 450, with confirmation of active inflammation

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0010346
SNOMED CT 2011_0131
34000006
MedDRA 14.1
10011401
ICD-10-CM Version 2010
K50.9
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C1442488
UMLS CUI 2011AA
C0451071
SNOMED CT 2011_0131
273364009
UMLS CUI 2011AA
C0449820
SNOMED CT 2011_0131
246262008
LOINC Version 232
MTHU024701
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0021368
SNOMED CT 2011_0131
23583003
MedDRA 14.1
10061218
Has failed conventional therapy as demonstrated by having received corticosteroids and/or immunomodulators(ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Have a history of failure to respond to or tolerate an adequate course of corticosteroids and/or immunomodulators (ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Is corticosteroid dependent or has had a history of corticosteroid dependency AND Has not previously demonstrated failure of or intolerance to 1 or more TNF-antagonist therapies (ie, infliximab, adalimumab, or certolizumab pegol) per study criteria
Description

Has failed conventional therapy as demonstrated by having received corticosteroids and/or immunomodulators(ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Have a history of failure to respond to or tolerate an adequate course of corticosteroids and/or immunomodulators (ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Is corticosteroid dependent or has had a history of corticosteroid dependency AND Has not previously demonstrated failure of or intolerance to 1 or more TNF-antagonist therapies (ie, infliximab, adalimumab, or certolizumab pegol) per study criteria

Data type

boolean

Alias
UMLS CUI 2011AA
C0231175
UMLS CUI 2011AA
CL429695
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UMLS CUI 2011AA
C1527392
SNOMED CT 2011_0131
108940007
UMLS CUI 2011AA
C0004482
SNOMED CT 2011_0131
372574004
LOINC Version 232
MTHU006794
UMLS CUI 2011AA
C0025677
SNOMED CT 2011_0131
387381009
LOINC Version 232
MTHU005020
UMLS CUI 2011AA
C0000618
SNOMED CT 2011_0131
386835005
LOINC Version 232
MTHU002562
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0162643
MedDRA 14.1
10066901
UMLS CUI 2011AA
C1456820
SNOMED CT 2011_0131
39525005
LOINC Version 232
MTHU004497
UMLS CUI 2011AA
C0243076
UMLS CUI 2011AA
C0666743
SNOMED CT 2011_0131
386891004
LOINC Version 232
MTHU018219
UMLS CUI 2011AA
C1122087
SNOMED CT 2011_0131
407317001
UMLS CUI 2011AA
C1172157
SNOMED CT 2011_0131
430307008
Have screening laboratory test results within protocol-specified parameters
Description

Have screening laboratory test results within protocol-specified parameters

Data type

boolean

Alias
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C0587081
SNOMED CT 2011_0131
118246004
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C2348563
UMLS CUI 2011AA
C0205369
SNOMED CT 2011_0131
69658003
UMLS CUI 2011AA
C0449381
SNOMED CT 2011_0131
252116004
Exclusion Criteria
Description

Exclusion Criteria

Patients who have had any kind of bowel resection within 6 months
Description

Patients who have had any kind of bowel resection within 6 months

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
CL407060
UMLS CUI 2011AA
C1706124
UMLS CUI 2011AA
C0741614
MedDRA 14.1
10067878
Are pregnant or planning pregnancy (both men and women) while enrolled in the study or for 20 weeks after receiving study agent
Description

Are pregnant or planning pregnancy (both men and women) while enrolled in the study or for 20 weeks after receiving study agent

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0032992
SNOMED CT 2011_0131
169565003
UMLS CUI 2011AA
C0025266
SNOMED CT 2011_0131
339947000
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
Patients who have received infliximab, adalimumab or certolizumab pegol < = 8 weeks before the first administration of study drug
Description

Patients who have received infliximab, adalimumab or certolizumab pegol < = 8 weeks before the first administration of study drug

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0666743
SNOMED CT 2011_0131
386891004
LOINC Version 232
MTHU018219
UMLS CUI 2011AA
C1122087
SNOMED CT 2011_0131
407317001
UMLS CUI 2011AA
C1172157
SNOMED CT 2011_0131
430307008
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1533734
SNOMED CT 2011_0131
416118004
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
Patients with certain complications of Crohn's disease that would make it hard to assess response to study drug
Description

Patients with certain complications of Crohn's disease that would make it hard to assess response to study drug

Data type

boolean

Alias
UMLS CUI 2011AA
C0009566
SNOMED CT 2011_0131
116223007
LOINC Version 232
MTHU008883
UMLS CUI 2011AA
C0010346
SNOMED CT 2011_0131
34000006
MedDRA 14.1
10011401
ICD-10-CM Version 2010
K50.9
UMLS CUI 2011AA
C1299586
SNOMED CT 2011_0131
52925006
UMLS CUI 2011AA
C1516048
UMLS CUI 2011AA
C0871261
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
Patients with a history of or ongoing chronic or recurrent infectious disease
Description

Patients with a history of or ongoing chronic or recurrent infectious disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0151317
SNOMED CT 2011_0131
177010002
UMLS CUI 2011AA
CL429630
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
40733004
MedDRA 14.1
10021881
LOINC Version 232
MTHU034915
ICD-9-CM Version 2011
136.9
Patients who have previously received a biologic agent targeting IL-12 or IL-23, including but not limited to ustekinumab (CNTO 1275) or briakinumab (ABT-874)
Description

Patients who have previously received a biologic agent targeting IL-12 or IL-23, including but not limited to ustekinumab (CNTO 1275) or briakinumab (ABT-874)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0005515
UMLS CUI 2011AA
C1521840
UMLS CUI 2011AA
C0123759
SNOMED CT 2011_0131
6411000
LOINC Version 232
MTHU003527
UMLS CUI 2011AA
C0963088
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C1608841
SNOMED CT 2011_0131
443644001
UMLS CUI 2011AA
C2744325
Back to the top of the page

Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Have Crohn's disease of at least 3 months' duration with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, or endoscopy
Item
Have Crohn's disease of at least 3 months' duration with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, or endoscopy
boolean
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0009319 (UMLS CUI 2011AA)
64226004 (SNOMED CT 2011_0131)
10009887 (MedDRA 14.1)
K52.9 (ICD-10-CM Version 2010)
E10521 (CTCAE 1105E)
C0020877 (UMLS CUI 2011AA)
52457000 (SNOMED CT 2011_0131)
10021312 (MedDRA 14.1)
K52.9 (ICD-10-CM Version 2010)
C0949272 (UMLS CUI 2011AA)
10062647 (MedDRA 14.1)
C0750484 (UMLS CUI 2011AA)
C0043299 (UMLS CUI 2011AA)
363680008 (SNOMED CT 2011_0131)
87 (ICD-9-CM Version 2011)
C0344441 (UMLS CUI 2011AA)
10062005 (MedDRA 14.1)
MTHU010496 (LOINC Version 232)
C0014245 (UMLS CUI 2011AA)
423827005 (SNOMED CT 2011_0131)
10014805 (MedDRA 14.1)
MTHU008659 (LOINC Version 232)
Have active Crohn's disease, defined as a baseline Crohn Disease Activity Index (CDAI) score of >= 220 and <= 450, with confirmation of active inflammation
Item
Have active Crohn's disease, defined as a baseline Crohn Disease Activity Index (CDAI) score of >= 220 and <= 450, with confirmation of active inflammation
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
C1704788 (UMLS CUI 2011AA)
C1442488 (UMLS CUI 2011AA)
C0451071 (UMLS CUI 2011AA)
273364009 (SNOMED CT 2011_0131)
C0449820 (UMLS CUI 2011AA)
246262008 (SNOMED CT 2011_0131)
MTHU024701 (LOINC Version 232)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0021368 (UMLS CUI 2011AA)
23583003 (SNOMED CT 2011_0131)
10061218 (MedDRA 14.1)
Has failed conventional therapy as demonstrated by having received corticosteroids and/or immunomodulators(ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Have a history of failure to respond to or tolerate an adequate course of corticosteroids and/or immunomodulators (ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Is corticosteroid dependent or has had a history of corticosteroid dependency AND Has not previously demonstrated failure of or intolerance to 1 or more TNF-antagonist therapies (ie, infliximab, adalimumab, or certolizumab pegol) per study criteria
Item
Has failed conventional therapy as demonstrated by having received corticosteroids and/or immunomodulators(ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Have a history of failure to respond to or tolerate an adequate course of corticosteroids and/or immunomodulators (ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Is corticosteroid dependent or has had a history of corticosteroid dependency AND Has not previously demonstrated failure of or intolerance to 1 or more TNF-antagonist therapies (ie, infliximab, adalimumab, or certolizumab pegol) per study criteria
boolean
C0231175 (UMLS CUI 2011AA)
CL429695 (UMLS CUI 2011AA)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C1527392 (UMLS CUI 2011AA)
108940007 (SNOMED CT 2011_0131)
C0004482 (UMLS CUI 2011AA)
372574004 (SNOMED CT 2011_0131)
MTHU006794 (LOINC Version 232)
C0025677 (UMLS CUI 2011AA)
387381009 (SNOMED CT 2011_0131)
MTHU005020 (LOINC Version 232)
C0000618 (UMLS CUI 2011AA)
386835005 (SNOMED CT 2011_0131)
MTHU002562 (LOINC Version 232)
C1518422 (UMLS CUI 2011AA)
C0162643 (UMLS CUI 2011AA)
10066901 (MedDRA 14.1)
C1456820 (UMLS CUI 2011AA)
39525005 (SNOMED CT 2011_0131)
MTHU004497 (LOINC Version 232)
C0243076 (UMLS CUI 2011AA)
C0666743 (UMLS CUI 2011AA)
386891004 (SNOMED CT 2011_0131)
MTHU018219 (LOINC Version 232)
C1122087 (UMLS CUI 2011AA)
407317001 (SNOMED CT 2011_0131)
C1172157 (UMLS CUI 2011AA)
430307008 (SNOMED CT 2011_0131)
Have screening laboratory test results within protocol-specified parameters
Item
Have screening laboratory test results within protocol-specified parameters
boolean
C1409616 (UMLS CUI 2011AA)
C0587081 (UMLS CUI 2011AA)
118246004 (SNOMED CT 2011_0131)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C2348563 (UMLS CUI 2011AA)
C0205369 (UMLS CUI 2011AA)
69658003 (SNOMED CT 2011_0131)
C0449381 (UMLS CUI 2011AA)
252116004 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
Patients who have had any kind of bowel resection within 6 months
Item
Patients who have had any kind of bowel resection within 6 months
boolean
C1514756 (UMLS CUI 2011AA)
CL407060 (UMLS CUI 2011AA)
C1706124 (UMLS CUI 2011AA)
C0741614 (UMLS CUI 2011AA)
10067878 (MedDRA 14.1)
Are pregnant or planning pregnancy (both men and women) while enrolled in the study or for 20 weeks after receiving study agent
Item
Are pregnant or planning pregnancy (both men and women) while enrolled in the study or for 20 weeks after receiving study agent
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0032992 (UMLS CUI 2011AA)
169565003 (SNOMED CT 2011_0131)
C0025266 (UMLS CUI 2011AA)
339947000 (SNOMED CT 2011_0131)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
Patients who have received infliximab, adalimumab or certolizumab pegol < = 8 weeks before the first administration of study drug
Item
Patients who have received infliximab, adalimumab or certolizumab pegol < = 8 weeks before the first administration of study drug
boolean
C1514756 (UMLS CUI 2011AA)
C0666743 (UMLS CUI 2011AA)
386891004 (SNOMED CT 2011_0131)
MTHU018219 (LOINC Version 232)
C1122087 (UMLS CUI 2011AA)
407317001 (SNOMED CT 2011_0131)
C1172157 (UMLS CUI 2011AA)
430307008 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1533734 (UMLS CUI 2011AA)
416118004 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
Patients with certain complications of Crohn's disease that would make it hard to assess response to study drug
Item
Patients with certain complications of Crohn's disease that would make it hard to assess response to study drug
boolean
C0009566 (UMLS CUI 2011AA)
116223007 (SNOMED CT 2011_0131)
MTHU008883 (LOINC Version 232)
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
C1299586 (UMLS CUI 2011AA)
52925006 (SNOMED CT 2011_0131)
C1516048 (UMLS CUI 2011AA)
C0871261 (UMLS CUI 2011AA)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
Patients with a history of or ongoing chronic or recurrent infectious disease
Item
Patients with a history of or ongoing chronic or recurrent infectious disease
boolean
C0151317 (UMLS CUI 2011AA)
177010002 (SNOMED CT 2011_0131)
CL429630 (UMLS CUI 2011AA)
C0009450 (UMLS CUI 2011AA)
40733004 (SNOMED CT 2011_0131)
10021881 (MedDRA 14.1)
MTHU034915 (LOINC Version 232)
136.9 (ICD-9-CM Version 2011)
Patients who have previously received a biologic agent targeting IL-12 or IL-23, including but not limited to ustekinumab (CNTO 1275) or briakinumab (ABT-874)
Item
Patients who have previously received a biologic agent targeting IL-12 or IL-23, including but not limited to ustekinumab (CNTO 1275) or briakinumab (ABT-874)
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C0005515 (UMLS CUI 2011AA)
C1521840 (UMLS CUI 2011AA)
C0123759 (UMLS CUI 2011AA)
6411000 (SNOMED CT 2011_0131)
MTHU003527 (LOINC Version 232)
C0963088 (UMLS CUI 2011AA)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C1608841 (UMLS CUI 2011AA)
443644001 (SNOMED CT 2011_0131)
C2744325 (UMLS CUI 2011AA)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial