NCT00162942

Study for the Treatment of Crohn's Disease With Adacolumn

A Randomized, Prospective, Double-Blinded, Placebo-Controlled (Sham-Controlled) Study to Evaluate the Safety and Effectiveness of the Adacolumn Apheresis System for the Treatment of Moderate to Severe Crohn's Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 235 (actual)
• Sponsor: Otsuka America Pharmaceutical · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of the Adacolumn Apheresis System as a treatment for the signs and symptoms of Crohn's disease.

Detailed description

Trial Features: * Medical device (Non-drug option) * Most patients can remain on current treatment regimen throughout the study Components of the Study: * Study length is 24 weeks, which includes a screening visit, ten treatment visits over nine weeks and 4 follow-up appointments * Physical exams, laboratory tests and disease assessments conducted at no charge to the patient * 2:1 Randomization (treatment:sham) * Open-Label extension offered to eligible patients

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DEVICE	Adacolumn	Ten apheresis sessions: One hour of Adacolumn Apheresis System procedure per visit. Patient had two procedures per week for the first two weeks followed by one apheresis session per weeks for two weeks (Weeks 1-4). then a week break occurs for rest followed by one apheresis session per week for 4 weeks (weeks 6-9).
DEVICE	Sham	Sham, ten apheresis sessions within 9 weeks

Timeline

• Start date: 2005-01-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2005-09-13
• Last updated: 2009-04-07
• Results posted: 2009-04-07

Locations

37 sites across 2 countries: United States, Canada