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

NCT00221026 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2016-10-19

No results posted yet for this study

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

Interventions

DRUG

Methoxsalen +ECP

ECP + Uvadex given at weeks 1-12 weeks.

PROCEDURE

Extracorporeal Photopheresis

ECP given at weeks 1 through 12.

Sponsors & Collaborators

  • ICON plc

    collaborator INDUSTRY

  • Mallinckrodt

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2006-06-30
Completion
2006-06-30

Countries

  • United States
  • Austria
  • Belgium
  • Germany

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00221026 on ClinicalTrials.gov