Eligibility NCT00048295

  1. StudyEvent: Eligibility
    1. Eligibility NCT00048295
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion
Age
Item
Age at least 12 years
integer
C0001779 (UMLS CUI-1)
Weight
Item
Weight at least 36 kg
boolean
C0005910 (UMLS CUI-1)
CDAI score
Item
CDAI score of 220 - 400
boolean
C0451071 (UMLS CUI-1)
Active Crohns disease
Item
Documentation of Crohns disease activity by endoscopy, biopsy or imaging in the last 2 years
boolean
C0010346 (UMLS CUI-1)
No TNF-alpha inhibitor
Item
No TNF-alpha inhibitor treatment for three months prior to first study drug infusion
boolean
C1518422 (UMLS CUI-1)
C1456820 (UMLS CUI-2)
C0021469 (UMLS CUI-3)
Item Group
Exclusion
Severe intestinal stenosis
Item
Known severe, fixed, symptomatic stenosis of the small or large intestine with significant dilation
boolean
C0521587 (UMLS CUI-1)
External fistulization
Item
Extensive external fistulization (> 3 external fistulae which are expressible with gentle compression); colostomy or ileostomy
boolean
C0016169 (UMLS CUI-1)
Infection
Item
Active infection, including infectious colitis, or infection with HIV, Hepatitis B or Hepatitis C
boolean
C0009450 (UMLS CUI-1)
Malignancy
Item
Malignancy within 3 years or poorly controlled medical illness
boolean
C0006826 (UMLS CUI-1)
Bleeding problem
Item
Requires intravenous heparin therapy or with a history of a bleeding problem
boolean
C1458140 (UMLS CUI-1)

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