NCT00221026

Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Crohn's Disease

A Multicenter, Open-Label, Study of Extracorporeal Photoimmune Therapy With UVADEX in the Treatment of Patients With Moderately Active Crohn's Disease Who Are Refractory or Intolerant to Immunosuppressants and/or Anti-TNF Agents

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

his study will explore the safety and activity of ECP treatment with UVADEX in inducing a clinical response (i.e., a CDAI decrease greater than or equal to 100 from baseline and/or a CDAI \< 150) over a 12-week period in moderately active Crohn's disease (CDAI greater than or equal to 220 to \< 450) patients who are refractory or intolerant to immunosuppressants and/or anti-TNF agents. This study will also assess response to continued treatment during a 12-week Extension Period in patients who have a clinical response at Week 12 of the Treatment Period and elect to participate in the Extension Period.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Methoxsalen +ECP	ECP + Uvadex given at weeks 1-12 weeks.
PROCEDURE	Extracorporeal Photopheresis	ECP given at weeks 1 through 12.

Timeline

• Start date: 2004-12-01
• Primary completion: 2006-06-01
• Completion: 2006-06-01
• First posted: 2005-09-22
• Last updated: 2016-10-19

Locations

15 sites across 4 countries: United States, Austria, Belgium, Germany