Safety and Tolerability of FITC-Adalimumab Administration During Confocal Laser Endomicroscopy of the Gut

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

January 31, 2011

Primary Completion Date

April 30, 2012

Study Completion Date

April 30, 2012

Conditions
Crohn's Disease
Interventions
DRUG

FITC-Adalimumab

The study product FITC-Adalimumab will be topically applied via a spray catheter to the intestinal mucosa of Crohn's disease patients during endomicroscopy of the gut. One mL of the diluted study product will be applied each time to overall four selected intestinal areas at a concentration of 20 μg/mL respectively (equivalent to 20 μg of FITC-Adalimumab per area). Total amount applied will be 80 μg FITC-Adalimumab per patient.

Trial Locations (1)

91054

Medizinische Klinik I, University Hospital Erlangen, Erlangen

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Abbott

INDUSTRY

lead

University of Erlangen-Nürnberg Medical School

OTHER