ID

44716

Description

ODM derived from http://clinicaltrials.gov/show/NCT01291810

Link

http://clinicaltrials.gov/show/NCT01291810

Keywords

Versions (3)
  1. 2/28/13 2/28/13 - Martin Dugas
  2. 4/19/14 4/19/14 - Julian Varghese
  3. 9/27/21 9/27/21 -
Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01291810 Crohn's Disease

German English

Eligibility

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

Inclusion Criteria

age 18 Years to 65 Years
Description

age 18 Years to 65 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Have had a diagnosis of Crohn's disease for at least 6 months.
Description

Have had a diagnosis of Crohn's disease for at least 6 months.

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0010346
SNOMED CT 2011_0131
34000006
MedDRA 14.1
10011401
ICD-10-CM Version 2010
K50.9
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
Moderate to severe active Crohn's disease defined as a Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450, and presence of colonic mucosal ulcerations in at least 2 segments, or ulcerations on ≥ 10% of the mucosal surface if only one segment is involved.
Description

Moderate to severe active Crohn's disease defined as a Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450, and presence of colonic mucosal ulcerations in at least 2 segments, or ulcerations on ≥ 10% of the mucosal surface if only one segment is involved.

Data type

boolean

Alias
UMLS CUI 2011AA
C1299393
SNOMED CT 2011_0131
371924009
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
C0451071
SNOMED CT 2011_0131
273364009
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0236053
SNOMED CT 2011_0131
95356008
MedDRA 14.1
10028124
UMLS CUI 2011AA
C0009368
SNOMED CT 2011_0131
71854001
LOINC Version 232
MTHU003023
UMLS CUI 2011AA
C0441635
SNOMED CT 2011_0131
264193005
Have developed secondary resistance to anti-TNFα therapy.
Description

Have developed secondary resistance to anti-TNFα therapy.

Data type

boolean

Alias
UMLS CUI 2011AA
C1511795
UMLS CUI 2011AA
C0175668
SNOMED CT 2011_0131
2603003
UMLS CUI 2011AA
C1514892
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0521124
SNOMED CT 2011_0131
65897001
UMLS CUI 2011AA
C1456820
SNOMED CT 2011_0131
39525005
LOINC Version 232
MTHU004497
Exclusion Criteria
Description

Exclusion Criteria

Primary non-response to a previously received treatment directed against TNFα Or Intolerance related to the primary pharmacological effect of anti-TNFα such as for instance, but not limited to, severe or opportunistic infections and demyelinating or autoimmune diseases.
Description

Primary non-response to a previously received treatment directed against TNFα Or Intolerance related to the primary pharmacological effect of anti-TNFα such as for instance, but not limited to, severe or opportunistic infections and demyelinating or autoimmune diseases.

Data type

boolean

Alias
UMLS CUI 2011AA
CL414904
UMLS CUI 2011AA
C0438286
SNOMED CT 2011_0131
266721009
MedDRA 14.1
10063670
UMLS CUI 2011AA
C0521124
SNOMED CT 2011_0131
65897001
UMLS CUI 2011AA
C1456820
SNOMED CT 2011_0131
39525005
LOINC Version 232
MTHU004497
UMLS CUI 2011AA
CL415164
HL7 V3 2006_05
OINT
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0029118
SNOMED CT 2011_0131
61274003
MedDRA 14.1
10030901
UMLS CUI 2011AA
C0011304
SNOMED CT 2011_0131
32693004
MedDRA 14.1
10012305
UMLS CUI 2011AA
C0004364
SNOMED CT 2011_0131
85828009
MedDRA 14.1
10061664
ICD-10-CM Version 2010
M30-M36
CTCAE 1105E
E11258
History of severe systemic bacterial, fungal, viral, or parasitic infections within the 3 months prior to screening; or the occurrence of any acute infection within 2 weeks of the first administration of study drug.
Description

History of severe systemic bacterial, fungal, viral, or parasitic infections within the 3 months prior to screening; or the occurrence of any acute infection within 2 weeks of the first administration of study drug.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0004623
SNOMED CT 2011_0131
87628006
MedDRA 14.1
10060945
ICD-10-CM Version 2010
A49.9
UMLS CUI 2011AA
C0026946
SNOMED CT 2011_0131
3218000
MedDRA 14.1
10017533
ICD-10-CM Version 2010
B35-B49
ICD-9-CM Version 2011
110-118.99
UMLS CUI 2011AA
C0042769
SNOMED CT 2011_0131
34014006
MedDRA 14.1
10047461
ICD-10-CM Version 2010
B34.9
UMLS CUI 2011AA
C0747256
SNOMED CT 2011_0131
17322007
MedDRA 14.1
10021857
UMLS CUI 2011AA
C0275518
SNOMED CT 2011_0131
63171007
Treatment with immunosuppressive or immunomodulatory drugs
Description

Treatment with immunosuppressive or immunomodulatory drugs

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0021081
SNOMED CT 2011_0131
372823004, 69431002
UMLS CUI 2011AA
C0005525
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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
age 18 Years to 65 Years
Item
age 18 Years to 65 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Have had a diagnosis of Crohn's disease for at least 6 months.
Item
Have had a diagnosis of Crohn's disease for at least 6 months.
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Moderate to severe active Crohn's disease defined as a Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450, and presence of colonic mucosal ulcerations in at least 2 segments, or ulcerations on ≥ 10% of the mucosal surface if only one segment is involved.
Item
Moderate to severe active Crohn's disease defined as a Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450, and presence of colonic mucosal ulcerations in at least 2 segments, or ulcerations on ≥ 10% of the mucosal surface if only one segment is involved.
boolean
C1299393 (UMLS CUI 2011AA)
371924009 (SNOMED CT 2011_0131)
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)
C0451071 (UMLS CUI 2011AA)
273364009 (SNOMED CT 2011_0131)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0236053 (UMLS CUI 2011AA)
95356008 (SNOMED CT 2011_0131)
10028124 (MedDRA 14.1)
C0009368 (UMLS CUI 2011AA)
71854001 (SNOMED CT 2011_0131)
MTHU003023 (LOINC Version 232)
C0441635 (UMLS CUI 2011AA)
264193005 (SNOMED CT 2011_0131)
Have developed secondary resistance to anti-TNFα therapy.
Item
Have developed secondary resistance to anti-TNFα therapy.
boolean
C1511795 (UMLS CUI 2011AA)
C0175668 (UMLS CUI 2011AA)
2603003 (SNOMED CT 2011_0131)
C1514892 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
C1456820 (UMLS CUI 2011AA)
39525005 (SNOMED CT 2011_0131)
MTHU004497 (LOINC Version 232)
Item Group
Exclusion Criteria
Primary non-response to a previously received treatment directed against TNFα Or Intolerance related to the primary pharmacological effect of anti-TNFα such as for instance, but not limited to, severe or opportunistic infections and demyelinating or autoimmune diseases.
Item
Primary non-response to a previously received treatment directed against TNFα Or Intolerance related to the primary pharmacological effect of anti-TNFα such as for instance, but not limited to, severe or opportunistic infections and demyelinating or autoimmune diseases.
boolean
CL414904 (UMLS CUI 2011AA)
C0438286 (UMLS CUI 2011AA)
266721009 (SNOMED CT 2011_0131)
10063670 (MedDRA 14.1)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
C1456820 (UMLS CUI 2011AA)
39525005 (SNOMED CT 2011_0131)
MTHU004497 (LOINC Version 232)
CL415164 (UMLS CUI 2011AA)
OINT (HL7 V3 2006_05)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0029118 (UMLS CUI 2011AA)
61274003 (SNOMED CT 2011_0131)
10030901 (MedDRA 14.1)
C0011304 (UMLS CUI 2011AA)
32693004 (SNOMED CT 2011_0131)
10012305 (MedDRA 14.1)
C0004364 (UMLS CUI 2011AA)
85828009 (SNOMED CT 2011_0131)
10061664 (MedDRA 14.1)
M30-M36 (ICD-10-CM Version 2010)
E11258 (CTCAE 1105E)
History of severe systemic bacterial, fungal, viral, or parasitic infections within the 3 months prior to screening; or the occurrence of any acute infection within 2 weeks of the first administration of study drug.
Item
History of severe systemic bacterial, fungal, viral, or parasitic infections within the 3 months prior to screening; or the occurrence of any acute infection within 2 weeks of the first administration of study drug.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0004623 (UMLS CUI 2011AA)
87628006 (SNOMED CT 2011_0131)
10060945 (MedDRA 14.1)
A49.9 (ICD-10-CM Version 2010)
C0026946 (UMLS CUI 2011AA)
3218000 (SNOMED CT 2011_0131)
10017533 (MedDRA 14.1)
B35-B49 (ICD-10-CM Version 2010)
110-118.99 (ICD-9-CM Version 2011)
C0042769 (UMLS CUI 2011AA)
34014006 (SNOMED CT 2011_0131)
10047461 (MedDRA 14.1)
B34.9 (ICD-10-CM Version 2010)
C0747256 (UMLS CUI 2011AA)
17322007 (SNOMED CT 2011_0131)
10021857 (MedDRA 14.1)
C0275518 (UMLS CUI 2011AA)
63171007 (SNOMED CT 2011_0131)
Treatment with immunosuppressive or immunomodulatory drugs
Item
Treatment with immunosuppressive or immunomodulatory drugs
boolean
C0039798 (UMLS CUI 2011AA)
C0021081 (UMLS CUI 2011AA)
372823004, 69431002 (SNOMED CT 2011_0131)
C0005525 (UMLS CUI 2011AA)
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