ID

42960

Description

see http://clinicaltrials.gov/ct2/show/study/NCT00048295 ISIS 2302 is an antisense oligonucleotide drug that reduces the production of a specific protein called intercellular adhesion molecule (ICAM-1), a substance that plays a significant role in the increase of inflammation. People with Crohn’s disease have been shown to over-produce ICAM-1 in their gut tissues. Alicaforsen works by blocking ICAM-1 messenger RNA, the “instruction” molecule that is required for the production of ICAM-1 protein. This trial will examine effects of alicaforsen delivered by 2-hour intravenous infusion over a four-week period, compared to a placebo. Patients may remain on stable background 5-ASA, antibiotic, or immunosuppressive drugs, and prednisone (or equivalent) at </= 30 mg per day.

Link

http://clinicaltrials.gov/ct2/show/study/NCT00048295

Keywords

  1. 11/14/11 11/14/11 -
  2. 11/14/11 11/14/11 -
  3. 3/22/14 3/22/14 - Martin Dugas
  4. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility NCT00048295 Crohns Disease

Eligibility NCT00048295

  1. StudyEvent: Eligibility
    1. Eligibility NCT00048295
Inclusion
Description

Inclusion

Age at least 12 years
Description

Age

Data type

integer

Measurement units
  • [years]
Alias
UMLS CUI-1
C0001779
[years]
Weight at least 36 kg
Description

Weight

Data type

boolean

Alias
UMLS CUI-1
C0005910
CDAI score of 220 - 400
Description

CDAI score

Data type

boolean

Alias
UMLS CUI-1
C0451071
Documentation of Crohns disease activity by endoscopy, biopsy or imaging in the last 2 years
Description

Active Crohns disease

Data type

boolean

Alias
UMLS CUI-1
C0010346
No TNF-alpha inhibitor treatment for three months prior to first study drug infusion
Description

No TNF-alpha inhibitor

Data type

boolean

Alias
UMLS CUI-1
C1518422
UMLS CUI-2
C1456820
UMLS CUI-3
C0021469
Exclusion
Description

Exclusion

Known severe, fixed, symptomatic stenosis of the small or large intestine with significant dilation
Description

Severe intestinal stenosis

Data type

boolean

Alias
UMLS CUI-1
C0521587
Extensive external fistulization (> 3 external fistulae which are expressible with gentle compression); colostomy or ileostomy
Description

External fistulization

Data type

boolean

Alias
UMLS CUI-1
C0016169
Active infection, including infectious colitis, or infection with HIV, Hepatitis B or Hepatitis C
Description

Infection

Data type

boolean

Alias
UMLS CUI-1
C0009450
Malignancy within 3 years or poorly controlled medical illness
Description

Malignancy

Data type

boolean

Alias
UMLS CUI-1
C0006826
Requires intravenous heparin therapy or with a history of a bleeding problem
Description

Bleeding problem

Data type

boolean

Alias
UMLS CUI-1
C1458140

Similar models

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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