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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.
Register: EUCTR
Last refreshed on: 21 August 2017
Main ID:  EUCTR2006-004784-58-GB
Date of registration: 30/04/2009
Prospective Registration: Yes
Primary sponsor: University of Leuven Hospitals
Public title: An Open Label, Prospective, Multi-Center Trial on the Effect of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) on Inflammatory and Fibrous Lesions in Patients with Intestinal Crohn's Diesease. ACTIF Trial. - Effect of Infliximab on MRI lesions in Crohn's - ACTIF study
Scientific title: An Open Label, Prospective, Multi-Center Trial on the Effect of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) on Inflammatory and Fibrous Lesions in Patients with Intestinal Crohn's Diesease. ACTIF Trial. - Effect of Infliximab on MRI lesions in Crohn's - ACTIF study
Date of first enrolment: 03/06/2009
Target sample size: 25
Recruitment status: Not Recruiting
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: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:  
Phase:  Human pharmacology (Phase I): Therapeutic exploratory (Phase II): Therapeutic confirmatory - (Phase III): Therapeutic use (Phase IV): yes
Countries of recruitment
Belgium France Germany United Kingdom
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
Inclusion criteria:
To be eligible for the trial, patients must meet all of the following inclusion criteria:
1) Men and women = 18 and = 65 years of age,
2) Are capable of understanding and signing an informed consent
3) Are considered eligible according to the following tuberculosis (TB) screening criteria:
a) Have no history of latent or active TB prior to screening
b) Have no signs or symptoms suggestive of active TB upon medical history or physical examination
c) Have had no recent close contact with a person with active TB
d) Have a chest radiograph (both posterior-anterior and lateral views), taken within 3 months prior to the first administration of infliximab and read by a qualified radiologist, with no evidence of current active TB or old inactive TB.
4) The presence of active disease:
a) CDAI > 220
b) CRP > 5 mg/L (see amendment to protocol)
5) Strong Gadolinium (Gd) uptake on baseline contrast enhanced MRI enteroclysis (see MRI manual)
6) Ileal wall thickening of > 4 mm on baseline contrast enhanced MRI enteroclysis
7) Men and women of childbearing potential must use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilization) for the duration of the study and should continue such precautions for 6 months after receiving the last medication

Exclusion Criteria:
Patients who meet any of the following criteria may not be enrolled in the study:
1) Have a medical contraindication for MRI enteroclysis (eg metal implants, including metal prosthetic heart valve(s), implantable devices, including a cardiac pacemaker and severe claustrophobia)
2) 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
3) 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)
4) Have had bowel resection of > 100 cm
5) Have presence of an abdominal abscess
6) Have MRI enteroclysis confirmed internal fistula
7) Be considered ineligible according to the TB eligibility assessment, screening, and early detection of reactivation rules defined in Section on: Tuberculosis Eligibility Assessment, Screening, and Early Detection of Reactivation Rules (refer to sections 5.9 and 18).
8) Have Screening laboratory test results as follows:
a) White blood cells (WBCs) < 3.0 x 109 cells/L
b) Platelets < 100 X 109 cells/L
c) Serum creatinine > 132 µmol/L (> 1,5 mg/dL)
d) Serum transaminase levels exceeding 2 times the upper limit of normal for the site laboratory
9) Have had any previous treatment with monoclonal antibodies or antibody fragments
10) Have a history of receiving human/murine recombinant products or a known allergy to murine products
11) Have documentation of seropositivity for human immunodeficiency virus (HIV)
12) Have a positive test for hepatitis B surface antigen or hepatitis C
13) History of alcohol or substance abuse in the 6 months prior to the study
14) Have a known history of serious infections (eg, hepatitis, pneumonia, or pyelonephritis) in the previous 3 months
15) Have a known history of a demyelinating disease, such as multiple sclerosis
16) Have or have had an opportunistic infection (eg, herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria othe

Exclusion criteria:
Ssee E3
Significant prestenotic dilatation of the ileum on baseline MRI scan
Previous resection of more than 100cm bowel
Presence of abdominal abscess


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Crohn's disease
MedDRA version: 8.1 Level: LLT Classification code 10011401 Term: Crohn's disease
Intervention(s)

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-

Primary Outcome(s)
Main Objective: The prinicipal aim of this study is to investigate the effect of infliximab on the transmural Inflammatory component and the fibrous lesions in the distal small bowel in patients with Crohn’s disease, based on serial MRI. This is a diagnostic, observational trial.

The primary endpoint of this study is the number of patients achieving a clinically significant change in MRI enteroclysis inflammatory sub-scores of severity in Ileal Crohn’s Disease (MICD); this is 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 19), as measured with contrast enhanced MRI enteroclysis at week 26 compared to baseline
Primary end point(s): The primary endpoint is the 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, as measured with contrast enhanced MRI enteroclysis at week 26 compared to baseline
Secondary Objective: Secondary endpoints include:
1) Changes in the overall MICD score at week 2 and week 26 compared to baseline
2) Changes in the individual MICD inflammatory subscores (wall thickening, contrast enhancement and extramural involvement) at week 2 and week 26 compared to baseline.
3) Changes in the individual MICD criteria for obstructive disease (intrastenotic luminal diameter and prestenotic dilation) at week 2 and week 26 compared to baseline.
4) Number of patients reaching CDAI remission (< 150) or CDAI response criteria (a drop of 100 points) at every visit (except week 30).
5) Correlation between the MICD total score and CDAI at baseline, week 2 and 26
6) Correlation between different MICD inflammatory subscores and CDAI at baseline, week 2 and 26
7) Correlation between the different MICD criteria for obstructive disease and CDAI at baseline, week 2 and 26
8) Changes in disease activity as measured with CDAI and Harvey Bradshaw questionnaire at every visit (except week 30).
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Secondary Outcome(s)
Secondary ID(s)
2006-004784-58-BE
GA08/8725
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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