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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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4 April 2022 |
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Main ID: |
EUCTR2006-004784-58-DE |
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Date of registration:
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11/03/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of infliximab on inflammatory and fibrous lesions in patients with intestinal Crohn’s disease - ACTIF
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Scientific title:
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Effect of infliximab on inflammatory and fibrous lesions in patients with intestinal Crohn’s disease - ACTIF |
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Date of first enrolment:
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27/05/2008 |
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Target sample size:
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25 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-004784-58 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Belgium
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France
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Germany
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Inclusion criteria
-Elevated CRP (>10 mg/L) and strong Gd uptake on baseline MRI
-age 16 to 50 yrs.
-Ileal Crohn’s disease failing immunomodulators and/or steroids for at least 3 months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Exclusion criteria
-Significant prestenotic dilation of the ileum on baseline MRI
-Resection of more than 100 cm bowel
-Presence of abdominal abscess
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Crohn's disease
MedDRA version: 8.1
Level: LLT
Classification code 10011401
Term: Crohn's disease
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Intervention(s)
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Trade Name: remicade
Product Name: remicade
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277313
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 5-
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Primary Outcome(s)
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Main Objective: To study changes in the inflammatory and the fibrous component of ileal segments in patients with ileal Crohn’s disease treated with infliximab at wk 0,2,6 and q8 wks thereafter.
Primary endpoint:
Number of patients achieving a clinically significant change in MRI enteroclysis score of severity in Ileal Crohn’s Disease (MICD); defined as an improvement of at least 2 points and at least 50% on the inflammatory subscores. i.e. 4 to 2 or 5 to 2 or 8 to 4 (subscores defined in section 21), as measured with contrast enhanced MRI enteroclysis (procedures defined in the MRI study manual) at week 26 compared to baseline.
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Primary end point(s): Changes in bowel wall thickness and inflammation on contrast enhanced MRI enteroclysis at 2 weeks and 6 months compared to baseline.
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Secondary Objective: To study:
-Clinical efficacy of infliximab in patients with ileal inflammatory stenosis based on CDAI remission and CDAI response (drop of 100 points or more).
-Safety
-Quality of life
-predictors of response (CRP, Gd enhancement on MRI, duration of disease, con meds)
-2 year resection rates
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Secondary ID(s)
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2006-004784-58-BE
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MRI-0143
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 22/01/2008
Contact:
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