99Tc labled Inliximab for evaluation of inflammatory activity in patients with inflammtory bowel disease (IBD)
Phase 1
- Conditions
- Inflammatory bowel diseaseCrohn´s diseaseUlcerative colitis
- Registration Number
- EUCTR2007-000842-11-AT
- Lead Sponsor
- Medical University of Graz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
active inflammatory bowel disease
age over 18 years
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
immune deficiency, allergy to infliximab, malignancy, severe infections, pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Comparison of szintigraphy using 99Tc labled infliximab for evaulation of inflammatory activity in patients with IBD inflammation seen by routine endoscopy ;Secondary Objective: ;Primary end point(s): Comparison of szintigraphy using 99Tc labled infliximab for evaulation of inflammatory activity and localisation in patients with active IBD. Results will be compared to inflammation seen by routine endoscopy.
- Secondary Outcome Measures
Name Time Method