Crohn’s disease MedDRA version: 17.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
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: 1702
Sponsors
First Department of Medicine, University of Szeged
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;Secondary Objective: Compare the radiopharmaceutical measurements with serum infliximab and anti infliximab antibody levels, and also with laboratory, fecal and clinical activity markers.;Primary end point(s): Assessment of the accumulation of 99mTc-infliximab in the gut mucosa of infliximab-treated patients with Crohn's disease.;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. | — |
Countries
Hungary
Outcome results
None listed