NCT00702611

Efficacy Study of Granulocytapheresis Plus Steroids vs Steroids Alone in Active Steroid Dependant Ulcerative Colitis

An Open Randomized Multicenter Clinical Investigation to Compare the Efficacy and Safety of Prednisone Plus Adacolumn® GMA Apheresis vs Prednisone Alone in the Treatment of Patients With Mild or Moderately Active Steroid Dependent Ulcerative Colitis

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of the addition of GMA apheresis to steroid conventional treatment for achieving and maintaining remission in Active steroid dependant Ulcerative Colitis patients

Detailed description

This is a multicenter randomized controlled trial which will compare the efficacy and safety of Adacolumn GMA apheresis plus oral steroids vs steroids alone in a strictly selected population of moderate to severe active steroid dependant Ulcerative Colitis patients.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DEVICE	Granulocyte Monocyte Apheresis (GMA-Apheresis)	GMA Apheresis will be performed in a once per week during seven weeks only in experimental arm. Each apheresis will last 60 minutes at a blood flow rate of 30 ml/min.

Timeline

• Start date: 2008-06-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2008-06-20
• Last updated: 2015-09-07

Locations

48 sites across 5 countries: Austria, Germany, Italy, Portugal, Spain