ID

4276

Description

ODM derived from http://clinicaltrials.gov/show/NCT00739986

Link

http://clinicaltrials.gov/show/NCT00739986

Keywords

Versions (2)
  1. 12/6/13 12/6/13 - Martin Dugas
  2. 4/16/14 4/16/14 - Julian Varghese
Uploaded on

December 6, 2013

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00739986 Crohn's Disease

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Men and women at least 18 years of age.
Description

Men and women at least 18 years of age.

Data type

boolean

Alias
UMLS CUI 2011AA
C0025266
SNOMED CT 2011_0131
339947000
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
Baseline Crohn's Disease Activity Index (CDAI) 250-400.
Description

Baseline Crohn's Disease Activity Index (CDAI) 250-400.

Data type

boolean

Alias
UMLS CUI 2011AA
C1442488
UMLS CUI 2011AA
C0451071
SNOMED CT 2011_0131
273364009
Crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed by radiography and/or endoscopy.
Description

Crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed by radiography and/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
C0043299
SNOMED CT 2011_0131
363680008
ICD-9-CM Version 2011
87
UMLS CUI 2011AA
C0014245
SNOMED CT 2011_0131
423827005
MedDRA 14.1
10014805
LOINC Version 232
MTHU008659
Those of childbearing potential were to use a barrier method (diaphragm or condom) of contraception and continue doing so for at least 3 months after last study medication. It was recommended that two forms be used.
Description

Those of childbearing potential were to use a barrier method (diaphragm or condom) of contraception and continue doing so for at least 3 months after last study medication. It was recommended that two forms be used.

Data type

boolean

Alias
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0004764
SNOMED CT 2011_0131
225370004
UMLS CUI 2011AA
C0042241
SNOMED CT 2011_0131
20359006
UMLS CUI 2011AA
C0677582
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0025663
SNOMED CT 2011_0131
260686004
LOINC Version 232
MTHU024654
Patients receiving medications for CD were to be on each medication for at least 8 weeks prior to screening and on stable doses of each for at least 2 weeks prior to screening, with the following exceptions:
Description

Patients receiving medications for CD were to be on each medication for at least 8 weeks prior to screening and on stable doses of each for at least 2 weeks prior to screening, with the following exceptions:

Data type

boolean

Alias
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0010346
SNOMED CT 2011_0131
34000006
MedDRA 14.1
10011401
ICD-10-CM Version 2010
K50.9
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
those on methotrexate had to be on a stable dose for at least 4 weeks and not be receiving > 25 mg/wk
Description

those on methotrexate had to be on a stable dose for at least 4 weeks and not be receiving > 25 mg/wk

Data type

boolean

Alias
UMLS CUI 2011AA
C0025677
SNOMED CT 2011_0131
387381009
LOINC Version 232
MTHU005020
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
those on azathioprine or 6-mercaptopurine on a stable dose for at least 10 weeks
Description

those on azathioprine or 6-mercaptopurine on a stable dose for at least 10 weeks

Data type

boolean

Alias
UMLS CUI 2011AA
C0004482
SNOMED CT 2011_0131
372574004
LOINC Version 232
MTHU006794
UMLS CUI 2011AA
C0000618
SNOMED CT 2011_0131
386835005
LOINC Version 232
MTHU002562
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0205456
SNOMED CT 2011_0131
3445001
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
those on steroids had to have been on steroids for at least 2 weeks and on a stable dose for those 2 weeks. They were not to be receiving > 20 mg/day prednisone or equivalent
Description

those on steroids had to have been on steroids for at least 2 weeks and on a stable dose for those 2 weeks. They were not to be receiving > 20 mg/day prednisone or equivalent

Data type

boolean

Alias
UMLS CUI 2011AA
C0038317
SNOMED CT 2011_0131
116566001
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0032952
SNOMED CT 2011_0131
116602009
LOINC Version 232
MTHU003245
UMLS CUI 2011AA
CL415123
those on mesalazine had to have been on for at least 6 weeks and on a stable dose for at least 2 weeks
Description

those on mesalazine had to have been on for at least 6 weeks and on a stable dose for at least 2 weeks

Data type

boolean

Alias
UMLS CUI 2011AA
C0127615
SNOMED CT 2011_0131
387501005
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
those on antibiotics for CD had to have been on for at least 2 weeks and on a stable dose for those 2 weeks
Description

those on antibiotics for CD had to have been on for at least 2 weeks and on a stable dose for those 2 weeks

Data type

boolean

Alias
UMLS CUI 2011AA
C0003232
SNOMED CT 2011_0131
255631004
UMLS CUI 2011AA
C0010346
SNOMED CT 2011_0131
34000006
MedDRA 14.1
10011401
ICD-10-CM Version 2010
K50.9
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
Any CD medication which had been discontinued was to have been discontinued at least 4 weeks prior to screening, with the exception of infliximab, which was to have been discontinued at least 8 weeks prior to screening.
Description

Any CD medication which had been discontinued was to have been discontinued at least 4 weeks prior to screening, with the exception of infliximab, which was to have been discontinued at least 8 weeks prior to screening.

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
C0013227
UMLS CUI 2011AA
C1444662
SNOMED CT 2011_0131
410546004
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C0666743
SNOMED CT 2011_0131
386891004
LOINC Version 232
MTHU018219
UMLS CUI 2011AA
C0205454
SNOMED CT 2011_0131
7319005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
The screening laboratory tests were to meet the following criteria:
Description

The screening laboratory tests were to meet the following criteria:

Data type

boolean

Alias
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C0022885
SNOMED CT 2011_0131
15220000
MedDRA 14.1
10059938
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
CL414621
Hgb >= 8.5 g/dL (5.3 mmol/L) WBC 3.5-20 x 109/L Neutrophils >= 1.5 x 109/L Platelets >= 100 x 109/L ALT (SGPT) <1.5 x the upper limit of normal range Alkaline phosphatase <2.5 x the upper limit of normal range Bilirubin <25 mmol/L (1.5 mg/dl) Creatinine <110 mol/L (1.2 mg/dl)
Description

Hgb >= 8.5 g/dL (5.3 mmol/L) WBC 3.5-20 x 109/L Neutrophils >= 1.5 x 109/L Platelets >= 100 x 109/L ALT (SGPT) <1.5 x the upper limit of normal range Alkaline phosphatase <2.5 x the upper limit of normal range Bilirubin <25 mmol/L (1.5 mg/dl) Creatinine <110 mol/L (1.2 mg/dl)

Data type

boolean

Alias
UMLS CUI 2011AA
C0518015
MedDRA 14.1
10018876
UMLS CUI 2011AA
C0023508
SNOMED CT 2011_0131
767002
MedDRA 14.1
10047939
UMLS CUI 2011AA
C0200633
SNOMED CT 2011_0131
30630007
MedDRA 14.1
10029363
UMLS CUI 2011AA
C1287267
SNOMED CT 2011_0131
365632008
LOINC Version 232
777-3
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C0002059
SNOMED CT 2011_0131
57056007
LOINC Version 232
MTHU005195
UMLS CUI 2011AA
C0011221
SNOMED CT 2011_0131
79706000
LOINC Version 232
1975-2
UMLS CUI 2011AA
C0010294
SNOMED CT 2011_0131
15373003
MedDRA 14.1
10011358
LOINC Version 232
38483-4
Patients were to be able to adhere to the study visit schedule and/or protocol requirements.
Description

Patients were to be able to adhere to the study visit schedule and/or protocol requirements.

Data type

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1554196
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C0086960
UMLS CUI 2011AA
C1709747
Patients were to be able to give informed consent and the consent was to be obtained prior to any study specific screening procedures.
Description

Patients were to be able to give informed consent and the consent was to be obtained prior to any study specific screening procedures.

Data type

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0184704
SNOMED CT 2011_0131
55149002
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0220908
SNOMED CT 2011_0131
20135006
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Treatment with any other experimental therapeutics within the last 4 weeks before enrolment.
Description

Treatment with any other experimental therapeutics within the last 4 weeks before enrolment.

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1516879
History of tuberculosis, either clinically or as evidenced by a positive chest x-ray (exclusion criterion #8) or PPD.
Description

History of tuberculosis, either clinically or as evidenced by a positive chest x-ray (exclusion criterion #8) or PPD.

Data type

boolean

Alias
UMLS CUI 2011AA
C0375796
ICD-10-CM Version 2010
Z86.11
ICD-9-CM Version 2011
V12.01
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
CL415097
UMLS CUI 2011AA
C0039985
SNOMED CT 2011_0131
399208008
MedDRA 14.1
10008498
UMLS CUI 2011AA
C0034131
SNOMED CT 2011_0131
108731003
Patients who had received anti-TNF therapy, such as infliximab, within 8 weeks of screening for this study. Patients who had received anti-TNF therapy >8 weeks prior to screening were eligible.
Description

Patients who had received anti-TNF therapy, such as infliximab, within 8 weeks of screening for this study. Patients who had received anti-TNF therapy >8 weeks prior to screening were eligible.

Data type

boolean

Alias
UMLS CUI 2011AA
C0281481
UMLS CUI 2011AA
C0666743
SNOMED CT 2011_0131
386891004
LOINC Version 232
MTHU018219
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0205454
SNOMED CT 2011_0131
7319005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C1409616
Patients with any ostomy, extensive bowel resection (e.g., > 100cm of small bowel, proctocolectomy or colectomy with ileorectal anastomosis). Segmental colectomy was permitted.
Description

Patients with any ostomy, extensive bowel resection (e.g., > 100cm of small bowel, proctocolectomy or colectomy with ileorectal anastomosis). Segmental colectomy was permitted.

Data type

boolean

Alias
UMLS CUI 2011AA
C0029473
SNOMED CT 2011_0131
75506009
UMLS CUI 2011AA
C0205231
SNOMED CT 2011_0131
41118005
UMLS CUI 2011AA
C0741614
MedDRA 14.1
10067878
UMLS CUI 2011AA
C0192601
SNOMED CT 2011_0131
107938000
MedDRA 14.1
10041105
UMLS CUI 2011AA
C0400076
SNOMED CT 2011_0131
174059005
MedDRA 14.1
10059848
UMLS CUI 2011AA
C0009274
SNOMED CT 2011_0131
23968004
MedDRA 14.1
10061778
UMLS CUI 2011AA
C0192754
SNOMED CT 2011_0131
81714000
MedDRA 14.1
10021320
UMLS CUI 2011AA
C0521104
SNOMED CT 2011_0131
75554001
UMLS CUI 2011AA
C0149750
SNOMED CT 2011_0131
43075005
MedDRA 14.1
10009878
Patients immediately in need of surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage.
Description

Patients immediately in need of surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage.

Data type

boolean

Alias
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0038895
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0017181
SNOMED CT 2011_0131
74474003
MedDRA 14.1
10017955
ICD-10-CM Version 2010
K92.2
ICD-9-CM Version 2011
578
UMLS CUI 2011AA
C0031154
SNOMED CT 2011_0131
48661000
MedDRA 14.1
10034674
ICD-10-CM Version 2010
K65
ICD-9-CM Version 2011
567.9
UMLS CUI 2011AA
C0021843
SNOMED CT 2011_0131
81060008
MedDRA 14.1
10022687
ICD-10-CM Version 2010
K56.60
ICD-9-CM Version 2011
560.9
UMLS CUI 2011AA
C0243001
SNOMED CT 2011_0131
75100008
MedDRA 14.1
10059621
UMLS CUI 2011AA
C0238334
SNOMED CT 2011_0131
69643006
MedDRA 14.1
10048984
ICD-10-CM Version 2010
K85
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0543467
SNOMED CT 2011_0131
83578000
MedDRA 14.1
10051332
LOINC Version 232
MTHU000079
UMLS CUI 2011AA
C0013103
SNOMED CT 2011_0131
122462000
Patients with known severe fixed symptomatic stenosis of the small or large intestine.
Description

Patients with known severe fixed symptomatic stenosis of the small or large intestine.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0151924
MedDRA 14.1
10062263
CTCAE 1105E
E11032
UMLS CUI 2011AA
C1261287
UMLS CUI 2011AA
C0021851
SNOMED CT 2011_0131
14742008
Evidence at the time of enrolment of bowel obstruction or history within the preceding six months as confirmed by radiography, endoscopy, or surgery.
Description

Evidence at the time of enrolment of bowel obstruction or history within the preceding six months as confirmed by radiography, endoscopy, or surgery.

Data type

boolean

Alias
UMLS CUI 2011AA
C0439547
SNOMED CT 2011_0131
272105005
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0021843
SNOMED CT 2011_0131
81060008
MedDRA 14.1
10022687
ICD-10-CM Version 2010
K56.60
ICD-9-CM Version 2011
560.9
UMLS CUI 2011AA
C0043299
SNOMED CT 2011_0131
363680008
ICD-9-CM Version 2011
87
UMLS CUI 2011AA
C0014245
SNOMED CT 2011_0131
423827005
MedDRA 14.1
10014805
LOINC Version 232
MTHU008659
UMLS CUI 2011AA
C0038895
Patients with a clinically significant abnormality or granulomata or any other evidence of primary tuberculosis infection on chest X-ray
Description

Patients with a clinically significant abnormality or granulomata or any other evidence of primary tuberculosis infection on chest X-ray

Data type

boolean

Alias
UMLS CUI 2011AA
C1704258
UMLS CUI 2011AA
C0018188
SNOMED CT 2011_0131
45647009
MedDRA 14.1
10018691
UMLS CUI 2011AA
CL414904
UMLS CUI 2011AA
C0041296
SNOMED CT 2011_0131
56717001
MedDRA 14.1
10044755
LOINC Version 232
MTHU020835
ICD-10-CM Version 2010
A15-A19
ICD-9-CM Version 2011
010-018.99
UMLS CUI 2011AA
C0021311
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0039985
SNOMED CT 2011_0131
399208008
MedDRA 14.1
10008498
Patients with current signs or symptoms of clinically significant hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease.
Description

Patients with current signs or symptoms of clinically significant hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0018939
SNOMED CT 2011_0131
191124002
MedDRA 14.1
10061590
ICD-10-CM Version 2010
D75.9
ICD-9-CM Version 2011
289.9
UMLS CUI 2011AA
C0014130
SNOMED CT 2011_0131
362969004
MedDRA 14.1
10014695
LOINC Version 232
MTHU021570
ICD-10-CM Version 2010
E34.9
ICD-9-CM Version 2011
259.9
UMLS CUI 2011AA
C0024115
SNOMED CT 2011_0131
19829001
MedDRA 14.1
10025082
ICD-10-CM Version 2010
J98.4
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
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
UMLS CUI 2011AA
C0234387
SNOMED CT 2011_0131
56681004
MedDRA 14.1
10054938
Patients with previous diagnosis of, or known, malignancies.
Description

Patients with previous diagnosis of, or known, malignancies.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332132
SNOMED CT 2011_0131
48318009
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
Patients with serious infections, such as hepatitis, HIV, pneumonia or pyelonephritis, within 3 months prior to screening.
Description

Patients with serious infections, such as hepatitis, HIV, pneumonia or pyelonephritis, within 3 months prior to screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205404
SNOMED CT 2011_0131
42745003
UMLS CUI 2011AA
C0021311
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0019158
SNOMED CT 2011_0131
29001004
MedDRA 14.1
10019717
UMLS CUI 2011AA
C0019682
SNOMED CT 2011_0131
19030005
UMLS CUI 2011AA
C0032285
SNOMED CT 2011_0131
233604007
MedDRA 14.1
10035664
LOINC Version 232
MTHU020831
ICD-10-CM Version 2010
J18.9
CTCAE 1105E
E13502
UMLS CUI 2011AA
C0034186
SNOMED CT 2011_0131
45816000
MedDRA 14.1
10037596
ICD-10-CM Version 2010
N16
ICD-9-CM Version 2011
590.80
CTCAE 1105E
E11431
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
History of opportunistic infections such as herpes zoster within 2 months prior to screening, evidence of active CMV, active Pneumocystis carinii, drug resistant atypical mycobacterium.
Description

History of opportunistic infections such as herpes zoster within 2 months prior to screening, evidence of active CMV, active Pneumocystis carinii, drug resistant atypical mycobacterium.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0029118
SNOMED CT 2011_0131
61274003
MedDRA 14.1
10030901
UMLS CUI 2011AA
C0019360
SNOMED CT 2011_0131
4740000
MedDRA 14.1
10019974
ICD-10-CM Version 2010
B02
ICD-9-CM Version 2011
53
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0010825
SNOMED CT 2011_0131
407444007
MedDRA 14.1
10009701
LOINC Version 232
MTHU033986
UMLS CUI 2011AA
C0032276
UMLS CUI 2011AA
C0013203
SNOMED CT 2011_0131
31438003
MedDRA 14.1
10059866
UMLS CUI 2011AA
C0026912
SNOMED CT 2011_0131
243368001
Patients with stool examination positive for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin.
Description

Patients with stool examination positive for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin.

Data type

boolean

Alias
UMLS CUI 2011AA
C0015733
SNOMED CT 2011_0131
39477002
LOINC Version 232
MTHU001007
UMLS CUI 2011AA
C0582103
SNOMED CT 2011_0131
225886003
UMLS CUI 2011AA
CL415097
UMLS CUI 2011AA
C0021853
SNOMED CT 2011_0131
261093006, 113276009
LOINC Version 232
MTHU003050, MTHU002653
UMLS CUI 2011AA
C0450254
SNOMED CT 2011_0131
264418008
UMLS CUI 2011AA
C0029974
SNOMED CT 2011_0131
73153001, 308796009, 263828003
LOINC Version 232
MTHU009318
UMLS CUI 2011AA
C0030498
SNOMED CT 2011_0131
37763007
LOINC Version 232
MTHU007791
UMLS CUI 2011AA
C0314765
SNOMED CT 2011_0131
12671002
Women who were pregnant or breast-feeding.
Description

Women who were pregnant or breast-feeding.

Data type

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
A psychiatric, addictive, or any disorder that compromises ability to give truly informed consent for participation in this study.
Description

A psychiatric, addictive, or any disorder that compromises ability to give truly informed consent for participation in this study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0004936
SNOMED CT 2011_0131
74732009
MedDRA 14.1
10037174
ICD-10-CM Version 2010
F99
ICD-9-CM Version 2011
290-319.99
UMLS CUI 2011AA
C0085281
SNOMED CT 2011_0131
32709003
MedDRA 14.1
10001125
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0221099
SNOMED CT 2011_0131
260379002
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0184704
SNOMED CT 2011_0131
55149002
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
Patients who had received CNI-1493 in the past.
Description

Patients who had received CNI-1493 in the past.

Data type

boolean

Alias
UMLS CUI 2011AA
C0384938
UMLS CUI 2011AA
C1273865
SNOMED CT 2011_0131
394829006
More than three doses of NSAIDs, including aspirin and COX-2 inhibitors, within the two weeks prior to start of study medication
Description

More than three doses of NSAIDs, including aspirin and COX-2 inhibitors, within the two weeks prior to start of study medication

Data type

boolean

Alias
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0003211
SNOMED CT 2011_0131
16403005, 372665008
UMLS CUI 2011AA
C0004057
SNOMED CT 2011_0131
7947003
UMLS CUI 2011AA
C1257954
SNOMED CT 2011_0131
387050005
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2348558
UMLS CUI 2011AA
C0013227
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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 at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Men and women at least 18 years of age.
Item
Men and women at least 18 years of age.
boolean
C0025266 (UMLS CUI 2011AA)
339947000 (SNOMED CT 2011_0131)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
Baseline Crohn's Disease Activity Index (CDAI) 250-400.
Item
Baseline Crohn's Disease Activity Index (CDAI) 250-400.
boolean
C1442488 (UMLS CUI 2011AA)
C0451071 (UMLS CUI 2011AA)
273364009 (SNOMED CT 2011_0131)
Crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed by radiography and/or endoscopy.
Item
Crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed by radiography and/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)
C0043299 (UMLS CUI 2011AA)
363680008 (SNOMED CT 2011_0131)
87 (ICD-9-CM Version 2011)
C0014245 (UMLS CUI 2011AA)
423827005 (SNOMED CT 2011_0131)
10014805 (MedDRA 14.1)
MTHU008659 (LOINC Version 232)
Those of childbearing potential were to use a barrier method (diaphragm or condom) of contraception and continue doing so for at least 3 months after last study medication. It was recommended that two forms be used.
Item
Those of childbearing potential were to use a barrier method (diaphragm or condom) of contraception and continue doing so for at least 3 months after last study medication. It was recommended that two forms be used.
boolean
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0004764 (UMLS CUI 2011AA)
225370004 (SNOMED CT 2011_0131)
C0042241 (UMLS CUI 2011AA)
20359006 (SNOMED CT 2011_0131)
C0677582 (UMLS CUI 2011AA)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0025663 (UMLS CUI 2011AA)
260686004 (SNOMED CT 2011_0131)
MTHU024654 (LOINC Version 232)
Patients receiving medications for CD were to be on each medication for at least 8 weeks prior to screening and on stable doses of each for at least 2 weeks prior to screening, with the following exceptions:
Item
Patients receiving medications for CD were to be on each medication for at least 8 weeks prior to screening and on stable doses of each for at least 2 weeks prior to screening, with the following exceptions:
boolean
C0013227 (UMLS CUI 2011AA)
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
those on methotrexate had to be on a stable dose for at least 4 weeks and not be receiving > 25 mg/wk
Item
those on methotrexate had to be on a stable dose for at least 4 weeks and not be receiving > 25 mg/wk
boolean
C0025677 (UMLS CUI 2011AA)
387381009 (SNOMED CT 2011_0131)
MTHU005020 (LOINC Version 232)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
those on azathioprine or 6-mercaptopurine on a stable dose for at least 10 weeks
Item
those on azathioprine or 6-mercaptopurine on a stable dose for at least 10 weeks
boolean
C0004482 (UMLS CUI 2011AA)
372574004 (SNOMED CT 2011_0131)
MTHU006794 (LOINC Version 232)
C0000618 (UMLS CUI 2011AA)
386835005 (SNOMED CT 2011_0131)
MTHU002562 (LOINC Version 232)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205456 (UMLS CUI 2011AA)
3445001 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
those on steroids had to have been on steroids for at least 2 weeks and on a stable dose for those 2 weeks. They were not to be receiving > 20 mg/day prednisone or equivalent
Item
those on steroids had to have been on steroids for at least 2 weeks and on a stable dose for those 2 weeks. They were not to be receiving > 20 mg/day prednisone or equivalent
boolean
C0038317 (UMLS CUI 2011AA)
116566001 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0032952 (UMLS CUI 2011AA)
116602009 (SNOMED CT 2011_0131)
MTHU003245 (LOINC Version 232)
CL415123 (UMLS CUI 2011AA)
those on mesalazine had to have been on for at least 6 weeks and on a stable dose for at least 2 weeks
Item
those on mesalazine had to have been on for at least 6 weeks and on a stable dose for at least 2 weeks
boolean
C0127615 (UMLS CUI 2011AA)
387501005 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
those on antibiotics for CD had to have been on for at least 2 weeks and on a stable dose for those 2 weeks
Item
those on antibiotics for CD had to have been on for at least 2 weeks and on a stable dose for those 2 weeks
boolean
C0003232 (UMLS CUI 2011AA)
255631004 (SNOMED CT 2011_0131)
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
Any CD medication which had been discontinued was to have been discontinued at least 4 weeks prior to screening, with the exception of infliximab, which was to have been discontinued at least 8 weeks prior to screening.
Item
Any CD medication which had been discontinued was to have been discontinued at least 4 weeks prior to screening, with the exception of infliximab, which was to have been discontinued at least 8 weeks prior to screening.
boolean
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
C0013227 (UMLS CUI 2011AA)
C1444662 (UMLS CUI 2011AA)
410546004 (SNOMED CT 2011_0131)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C0666743 (UMLS CUI 2011AA)
386891004 (SNOMED CT 2011_0131)
MTHU018219 (LOINC Version 232)
C0205454 (UMLS CUI 2011AA)
7319005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
The screening laboratory tests were to meet the following criteria:
Item
The screening laboratory tests were to meet the following criteria:
boolean
C1409616 (UMLS CUI 2011AA)
C0022885 (UMLS CUI 2011AA)
15220000 (SNOMED CT 2011_0131)
10059938 (MedDRA 14.1)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
Hgb >= 8.5 g/dL (5.3 mmol/L) WBC 3.5-20 x 109/L Neutrophils >= 1.5 x 109/L Platelets >= 100 x 109/L ALT (SGPT) <1.5 x the upper limit of normal range Alkaline phosphatase <2.5 x the upper limit of normal range Bilirubin <25 mmol/L (1.5 mg/dl) Creatinine <110 mol/L (1.2 mg/dl)
Item
Hgb >= 8.5 g/dL (5.3 mmol/L) WBC 3.5-20 x 109/L Neutrophils >= 1.5 x 109/L Platelets >= 100 x 109/L ALT (SGPT) <1.5 x the upper limit of normal range Alkaline phosphatase <2.5 x the upper limit of normal range Bilirubin <25 mmol/L (1.5 mg/dl) Creatinine <110 mol/L (1.2 mg/dl)
boolean
C0518015 (UMLS CUI 2011AA)
10018876 (MedDRA 14.1)
C0023508 (UMLS CUI 2011AA)
767002 (SNOMED CT 2011_0131)
10047939 (MedDRA 14.1)
C0200633 (UMLS CUI 2011AA)
30630007 (SNOMED CT 2011_0131)
10029363 (MedDRA 14.1)
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
C0002059 (UMLS CUI 2011AA)
57056007 (SNOMED CT 2011_0131)
MTHU005195 (LOINC Version 232)
C0011221 (UMLS CUI 2011AA)
79706000 (SNOMED CT 2011_0131)
1975-2 (LOINC Version 232)
C0010294 (UMLS CUI 2011AA)
15373003 (SNOMED CT 2011_0131)
10011358 (MedDRA 14.1)
38483-4 (LOINC Version 232)
Patients were to be able to adhere to the study visit schedule and/or protocol requirements.
Item
Patients were to be able to adhere to the study visit schedule and/or protocol requirements.
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0086960 (UMLS CUI 2011AA)
C1709747 (UMLS CUI 2011AA)
Patients were to be able to give informed consent and the consent was to be obtained prior to any study specific screening procedures.
Item
Patients were to be able to give informed consent and the consent was to be obtained prior to any study specific screening procedures.
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0184704 (UMLS CUI 2011AA)
55149002 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0220908 (UMLS CUI 2011AA)
20135006 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Treatment with any other experimental therapeutics within the last 4 weeks before enrolment.
Item
Treatment with any other experimental therapeutics within the last 4 weeks before enrolment.
boolean
C0039798 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
History of tuberculosis, either clinically or as evidenced by a positive chest x-ray (exclusion criterion #8) or PPD.
Item
History of tuberculosis, either clinically or as evidenced by a positive chest x-ray (exclusion criterion #8) or PPD.
boolean
C0375796 (UMLS CUI 2011AA)
Z86.11 (ICD-10-CM Version 2010)
V12.01 (ICD-9-CM Version 2011)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
CL415097 (UMLS CUI 2011AA)
C0039985 (UMLS CUI 2011AA)
399208008 (SNOMED CT 2011_0131)
10008498 (MedDRA 14.1)
C0034131 (UMLS CUI 2011AA)
108731003 (SNOMED CT 2011_0131)
Patients who had received anti-TNF therapy, such as infliximab, within 8 weeks of screening for this study. Patients who had received anti-TNF therapy >8 weeks prior to screening were eligible.
Item
Patients who had received anti-TNF therapy, such as infliximab, within 8 weeks of screening for this study. Patients who had received anti-TNF therapy >8 weeks prior to screening were eligible.
boolean
C0281481 (UMLS CUI 2011AA)
C0666743 (UMLS CUI 2011AA)
386891004 (SNOMED CT 2011_0131)
MTHU018219 (LOINC Version 232)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205454 (UMLS CUI 2011AA)
7319005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C1409616 (UMLS CUI 2011AA)
Patients with any ostomy, extensive bowel resection (e.g., > 100cm of small bowel, proctocolectomy or colectomy with ileorectal anastomosis). Segmental colectomy was permitted.
Item
Patients with any ostomy, extensive bowel resection (e.g., > 100cm of small bowel, proctocolectomy or colectomy with ileorectal anastomosis). Segmental colectomy was permitted.
boolean
C0029473 (UMLS CUI 2011AA)
75506009 (SNOMED CT 2011_0131)
C0205231 (UMLS CUI 2011AA)
41118005 (SNOMED CT 2011_0131)
C0741614 (UMLS CUI 2011AA)
10067878 (MedDRA 14.1)
C0192601 (UMLS CUI 2011AA)
107938000 (SNOMED CT 2011_0131)
10041105 (MedDRA 14.1)
C0400076 (UMLS CUI 2011AA)
174059005 (SNOMED CT 2011_0131)
10059848 (MedDRA 14.1)
C0009274 (UMLS CUI 2011AA)
23968004 (SNOMED CT 2011_0131)
10061778 (MedDRA 14.1)
C0192754 (UMLS CUI 2011AA)
81714000 (SNOMED CT 2011_0131)
10021320 (MedDRA 14.1)
C0521104 (UMLS CUI 2011AA)
75554001 (SNOMED CT 2011_0131)
C0149750 (UMLS CUI 2011AA)
43075005 (SNOMED CT 2011_0131)
10009878 (MedDRA 14.1)
Patients immediately in need of surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage.
Item
Patients immediately in need of surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage.
boolean
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0038895 (UMLS CUI 2011AA)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0017181 (UMLS CUI 2011AA)
74474003 (SNOMED CT 2011_0131)
10017955 (MedDRA 14.1)
K92.2 (ICD-10-CM Version 2010)
578 (ICD-9-CM Version 2011)
C0031154 (UMLS CUI 2011AA)
48661000 (SNOMED CT 2011_0131)
10034674 (MedDRA 14.1)
K65 (ICD-10-CM Version 2010)
567.9 (ICD-9-CM Version 2011)
C0021843 (UMLS CUI 2011AA)
81060008 (SNOMED CT 2011_0131)
10022687 (MedDRA 14.1)
K56.60 (ICD-10-CM Version 2010)
560.9 (ICD-9-CM Version 2011)
C0243001 (UMLS CUI 2011AA)
75100008 (SNOMED CT 2011_0131)
10059621 (MedDRA 14.1)
C0238334 (UMLS CUI 2011AA)
69643006 (SNOMED CT 2011_0131)
10048984 (MedDRA 14.1)
K85 (ICD-10-CM Version 2010)
C1514873 (UMLS CUI 2011AA)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C0013103 (UMLS CUI 2011AA)
122462000 (SNOMED CT 2011_0131)
Patients with known severe fixed symptomatic stenosis of the small or large intestine.
Item
Patients with known severe fixed symptomatic stenosis of the small or large intestine.
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0151924 (UMLS CUI 2011AA)
10062263 (MedDRA 14.1)
E11032 (CTCAE 1105E)
C1261287 (UMLS CUI 2011AA)
C0021851 (UMLS CUI 2011AA)
14742008 (SNOMED CT 2011_0131)
Evidence at the time of enrolment of bowel obstruction or history within the preceding six months as confirmed by radiography, endoscopy, or surgery.
Item
Evidence at the time of enrolment of bowel obstruction or history within the preceding six months as confirmed by radiography, endoscopy, or surgery.
boolean
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0021843 (UMLS CUI 2011AA)
81060008 (SNOMED CT 2011_0131)
10022687 (MedDRA 14.1)
K56.60 (ICD-10-CM Version 2010)
560.9 (ICD-9-CM Version 2011)
C0043299 (UMLS CUI 2011AA)
363680008 (SNOMED CT 2011_0131)
87 (ICD-9-CM Version 2011)
C0014245 (UMLS CUI 2011AA)
423827005 (SNOMED CT 2011_0131)
10014805 (MedDRA 14.1)
MTHU008659 (LOINC Version 232)
C0038895 (UMLS CUI 2011AA)
Patients with a clinically significant abnormality or granulomata or any other evidence of primary tuberculosis infection on chest X-ray
Item
Patients with a clinically significant abnormality or granulomata or any other evidence of primary tuberculosis infection on chest X-ray
boolean
C1704258 (UMLS CUI 2011AA)
C0018188 (UMLS CUI 2011AA)
45647009 (SNOMED CT 2011_0131)
10018691 (MedDRA 14.1)
CL414904 (UMLS CUI 2011AA)
C0041296 (UMLS CUI 2011AA)
56717001 (SNOMED CT 2011_0131)
10044755 (MedDRA 14.1)
MTHU020835 (LOINC Version 232)
A15-A19 (ICD-10-CM Version 2010)
010-018.99 (ICD-9-CM Version 2011)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0039985 (UMLS CUI 2011AA)
399208008 (SNOMED CT 2011_0131)
10008498 (MedDRA 14.1)
Patients with current signs or symptoms of clinically significant hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease.
Item
Patients with current signs or symptoms of clinically significant hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease.
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0018939 (UMLS CUI 2011AA)
191124002 (SNOMED CT 2011_0131)
10061590 (MedDRA 14.1)
D75.9 (ICD-10-CM Version 2010)
289.9 (ICD-9-CM Version 2011)
C0014130 (UMLS CUI 2011AA)
362969004 (SNOMED CT 2011_0131)
10014695 (MedDRA 14.1)
MTHU021570 (LOINC Version 232)
E34.9 (ICD-10-CM Version 2010)
259.9 (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)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
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)
C0234387 (UMLS CUI 2011AA)
56681004 (SNOMED CT 2011_0131)
10054938 (MedDRA 14.1)
Patients with previous diagnosis of, or known, malignancies.
Item
Patients with previous diagnosis of, or known, malignancies.
boolean
C0332132 (UMLS CUI 2011AA)
48318009 (SNOMED CT 2011_0131)
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
Patients with serious infections, such as hepatitis, HIV, pneumonia or pyelonephritis, within 3 months prior to screening.
Item
Patients with serious infections, such as hepatitis, HIV, pneumonia or pyelonephritis, within 3 months prior to screening.
boolean
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0019158 (UMLS CUI 2011AA)
29001004 (SNOMED CT 2011_0131)
10019717 (MedDRA 14.1)
C0019682 (UMLS CUI 2011AA)
19030005 (SNOMED CT 2011_0131)
C0032285 (UMLS CUI 2011AA)
233604007 (SNOMED CT 2011_0131)
10035664 (MedDRA 14.1)
MTHU020831 (LOINC Version 232)
J18.9 (ICD-10-CM Version 2010)
E13502 (CTCAE 1105E)
C0034186 (UMLS CUI 2011AA)
45816000 (SNOMED CT 2011_0131)
10037596 (MedDRA 14.1)
N16 (ICD-10-CM Version 2010)
590.80 (ICD-9-CM Version 2011)
E11431 (CTCAE 1105E)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
History of opportunistic infections such as herpes zoster within 2 months prior to screening, evidence of active CMV, active Pneumocystis carinii, drug resistant atypical mycobacterium.
Item
History of opportunistic infections such as herpes zoster within 2 months prior to screening, evidence of active CMV, active Pneumocystis carinii, drug resistant atypical mycobacterium.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0029118 (UMLS CUI 2011AA)
61274003 (SNOMED CT 2011_0131)
10030901 (MedDRA 14.1)
C0019360 (UMLS CUI 2011AA)
4740000 (SNOMED CT 2011_0131)
10019974 (MedDRA 14.1)
B02 (ICD-10-CM Version 2010)
53 (ICD-9-CM Version 2011)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0010825 (UMLS CUI 2011AA)
407444007 (SNOMED CT 2011_0131)
10009701 (MedDRA 14.1)
MTHU033986 (LOINC Version 232)
C0032276 (UMLS CUI 2011AA)
C0013203 (UMLS CUI 2011AA)
31438003 (SNOMED CT 2011_0131)
10059866 (MedDRA 14.1)
C0026912 (UMLS CUI 2011AA)
243368001 (SNOMED CT 2011_0131)
Patients with stool examination positive for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin.
Item
Patients with stool examination positive for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin.
boolean
C0015733 (UMLS CUI 2011AA)
39477002 (SNOMED CT 2011_0131)
MTHU001007 (LOINC Version 232)
C0582103 (UMLS CUI 2011AA)
225886003 (SNOMED CT 2011_0131)
CL415097 (UMLS CUI 2011AA)
C0021853 (UMLS CUI 2011AA)
261093006, 113276009 (SNOMED CT 2011_0131)
MTHU003050, MTHU002653 (LOINC Version 232)
C0450254 (UMLS CUI 2011AA)
264418008 (SNOMED CT 2011_0131)
C0029974 (UMLS CUI 2011AA)
73153001, 308796009, 263828003 (SNOMED CT 2011_0131)
MTHU009318 (LOINC Version 232)
C0030498 (UMLS CUI 2011AA)
37763007 (SNOMED CT 2011_0131)
MTHU007791 (LOINC Version 232)
C0314765 (UMLS CUI 2011AA)
12671002 (SNOMED CT 2011_0131)
Women who were pregnant or breast-feeding.
Item
Women who were pregnant or breast-feeding.
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
A psychiatric, addictive, or any disorder that compromises ability to give truly informed consent for participation in this study.
Item
A psychiatric, addictive, or any disorder that compromises ability to give truly informed consent for participation in this study.
boolean
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0085281 (UMLS CUI 2011AA)
32709003 (SNOMED CT 2011_0131)
10001125 (MedDRA 14.1)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0184704 (UMLS CUI 2011AA)
55149002 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
Patients who had received CNI-1493 in the past.
Item
Patients who had received CNI-1493 in the past.
boolean
C0384938 (UMLS CUI 2011AA)
C1273865 (UMLS CUI 2011AA)
394829006 (SNOMED CT 2011_0131)
More than three doses of NSAIDs, including aspirin and COX-2 inhibitors, within the two weeks prior to start of study medication
Item
More than three doses of NSAIDs, including aspirin and COX-2 inhibitors, within the two weeks prior to start of study medication
boolean
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0003211 (UMLS CUI 2011AA)
16403005, 372665008 (SNOMED CT 2011_0131)
C0004057 (UMLS CUI 2011AA)
7947003 (SNOMED CT 2011_0131)
C1257954 (UMLS CUI 2011AA)
387050005 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
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