NCT01481142

Adacolumn in Refractory UC Patients Trial

Multicentre Investigation of the Efficacy and Safety of Adacolumn® GMA in Patients With Steroid-Dependent Active Ulcerative Colitis and Insufficient Response or Intolerance to Immunosuppressants and/or Biological Therapies

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Otsuka Pharmaceutical Europe Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objectives of the study are to observe and document the efficacy and safety of 5 or more Adacolumn treatments, administered once weekly over 5 or more weeks, in a specific subset of ulcerative colitis patients. The patient subset of interest is those with moderate/severe, steroid-dependent, active ulcerative colitis with insufficient response or intolerance to immunosuppressants and/or biological agents.

Conditions

• Ulcerative Colitis, Active Moderate

Interventions

Type	Name	Description
DEVICE	(GMA) Adsorptive Apheresis	Patients will be treated with once-weekly Adacolumn® apheresis over 5 consecutive weeks; treatment can be extended to up to 10 treatments administered once weekly over 10 weeks.

Timeline

• Start date: 2011-10-01
• Primary completion: 2015-05-01
• Completion: 2015-07-01
• First posted: 2011-11-29
• Last updated: 2015-10-19

Locations

1 site across 1 country: France