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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: 28 August 2014
Main ID:  EUCTR2013-005629-21-HU
Date of registration: 11/06/2014
Prospective Registration: Yes
Primary sponsor: First Department of Medicine, University of Szeged
Public title: Diagnostic use of 99mTecnetium labeled infliximab in Crohn’s disease
Scientific title: Diagnostic use of 99mTecnetium labeled infliximab in Crohn’s disease
Date of first enrolment: 14/08/2014
Target sample size:
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-005629-21
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: no Open: yes 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
Hungary
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
18-75 years of age. Ileal, colonic or ileocolonic Crohn's disease. Infliximab therapy due to active, refractory Crohn’s disease. Excluded pregnancy.
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:
Known allergy or intolerance to one of the medicaments or their ingredients utilized in the study .
Pregnancy and breast feeding. Concomitant severe infections. TB.
Sepsis. Abscess. Opportunistic infections. Moderate or severe heart failure (NYHA III/IV). Malignant diseases. Mental impairment, addicitve or other disorders leading to the patients inability to understand the scope and possible consequences of a participation in the clinical trial.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Crohn’s disease
MedDRA version: 17.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Intervention(s)

Trade Name: Remicade
Product Name: Infliximab (Remicade): 100 mg of lyophilized infliximab
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)
Main Objective: After labeling infliximab with 99mTecnetium the main obejctive of this study is to assess the distribution of 99mTc-infliximab in the gut mucosa of Crohn’s disease patients treated regularly with infliximab.
Primary end point(s): Assessment of the accumulation of 99mTc-infliximab in the gut mucosa of infliximab-treated patients with Crohn's disease.
Secondary Objective: Compare the radiopharmaceutical measurements with serum infliximab and anti infliximab antibody levels, and also with laboratory, fecal and clinical activity markers.
Timepoint(s) of evaluation of this end point: Diagnosis is carried out in the 6th, 20th and 168th hour after treatment with 99m technecium labelled infliximab.
Secondary Outcome(s)
Secondary ID(s)
abbreviated title
Tech-infliximab2014/1
Source(s) of Monetary Support
First Department of Medicine, University of Szeged
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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