Diagnostic use of 99mTecnetium labeled infliximab in Crohn’s disease

• Conditions: Crohn’s disease; MedDRA version: 17.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2013-005629-21-HU
• Lead Sponsor: First Department of Medicine, University of Szeged

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-11
• Last Update Posted: 28 August 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified