Study for the Treatment of Crohn's Disease With Adacolumn

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00162942
Study type	Interventional
Source	Otsuka America Pharmaceutical
Contact
Status	Completed
Phase	Phase 3
Start date	January 2005
Completion date	December 2007

View Details

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