World Health Organization site
Skip Navigation Links

Main
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.
Register: EUCTR
Last refreshed on: 19 March 2012
Main ID:  EUCTR2006-004784-58-FR
Date of registration: 24/06/2008
Prospective Registration: Yes
Primary sponsor: CHRU de Lille
Public title: An open label, prospective, multicenter trial, on the effect of anti-TNF alpha Chimeric monoclonal antibody (Infliximab, Remicade) on the inflammatory and fibrous lesions in patients with intestinal Crohn's Disease.
Scientific title: An open label, prospective, multicenter trial, on the effect of anti-TNF alpha Chimeric monoclonal antibody (Infliximab, Remicade) on the inflammatory and fibrous lesions in patients with intestinal Crohn's Disease.
Date of first enrolment: 07/07/2008
Target sample size: 25
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-004784-58
Study type:  Interventional clinical trial of medicinal product
Study design:  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  
Phase: 
Countries of recruitment
Belgium France Germany United Kingdom
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria:
- Men and women = 18 and = 65 years of age,
- Are capable of understanding and signing an informed consent
- Are considered eligible according to the following tuberculosis (TB) screening criteria,
- The presence of active disease (CDAI > 220, CRP > 10 mg/L),
- ...


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) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Have a medical contraindication for MRI enteroclysis,
- Use more than 15 mg of oral steroids (prednisone or equivalent) within the 2 weeks prior to baseline MRI. IV use of steroids is not allowed within that same period,
- Have a severe prestenotic dilation of the ileum on screening MRI (severe dilation is defined as > 2 times the luminal diameter of the unaffected ileum),
- Have had bowel resection of > 100 cm,
- Person with no social insurance,
- Have presence of an abdominal abscess,
- Have MRI enteroclysis confirmed internal fistula,
- Be considered ineligible according to the tuberculosis criteria,
- Have non conform screening laboratory tests results,
- Active participation in another clinical trial or having been included in a clinical trial until 3 months before screening,
- ...


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Crohn's disease
Intervention(s)

Trade Name: Selective Immunosuppressive agents
Product Name: Remicade 100 mg
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: infliximab
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)
Main Objective: The primary objective of the study is to assess the intermediate effects of infliximab on the inflammatory components of the MRI enteroclysis score of severity in Ileal Crohn’s Disease (MICD, see 20.) in patients with Crohn’s disease.
Primary end point(s): The primary endpoint is the number of patients achieving a clinically significant change in MRI enteroclysis inflammatory sub-scores 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, as measured with contrast enhanced MRI enteroclysis at week 26 compared to baseline.
Secondary Objective: The major secondary objectives include:
1. The short term effects of infliximab on MICD
2. The effects of infliximab on the individual components of the MICD score and on the total score classifying the severity of inflammation and obstructive disease
3. The effect of infliximab on disease activity and quality of life from day 1 after the first infusion
4. Validation of the MRI enteroclysis scoring system
Secondary Outcome(s)
Secondary ID(s)
2006-004784-58-BE
MRI-0143 ACTIF
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history