NCT00366925

CESA 5.10 Investigation to Compare the Efficacy and Safety of the Adacolumn® Apheresis Device in Patients With Active Ulcerative Colitis

Randomized Controlled Multicenter Investigation to Compare the Efficacy and Safety of Adacolumn® Granulocytes, Monocytes/Macrophage Apheresis Device, 5 Versus 10 Treatments, in Patients With Active Ulcerative Colitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: Otsuka Frankfurt Research Institute GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

The purpose of this study is to compare the safety and efficacy of 5 Adacolumn® treatments over 5 weeks to 10 treatments (two Adacolumn® apheresis treatments during the first 2 weeks, followed by 6 weeks with one Adacolumn® apheresis treatment) in patients with active ulcerative colitis.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DEVICE	Adacolumn®

Timeline

• Start date: 2006-04-01
• Primary completion: 2008-02-01
• Completion: 2008-07-01
• First posted: 2006-08-22
• Last updated: 2009-04-28

Locations

1 site across 1 country: Germany