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| Sponsor: | Therakos |
|---|---|
| Collaborator: |
ICON |
| Information provided by: | Therakos |
| ClinicalTrials.gov Identifier: | NCT00221026 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Crohn's Disease |
Drug: Methoxsalen +ECP Procedure: Extracorporeal Photopheresis |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
| Enrollment: | 25 |
| Study Start Date: | December 2004 |
| Study Completion Date: | June 2006 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: drug
ECP + Uvadex given for 12 weeks.
|
Drug: Methoxsalen +ECP
ECP + Uvadex given at weeks 1-12 weeks.
Other Name: Uvadex
Procedure: Extracorporeal Photopheresis
ECP given at weeks 1 through 12.
Other Name: uvadex+ECP
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Maryland | |
| NIH | |
| Bethesda, Maryland, United States | |
| Metropolitian Gastroenterology Group | |
| Chevy Chase, Maryland, United States | |
| United States, New Jersey | |
| Morristown Memorial Hospital | |
| Morristown, New Jersey, United States | |
| United States, New York | |
| Mount Sinai Medical Center | |
| New York, New York, United States | |
| Austria | |
| General Hospital of Vienna | |
| Vienna, Austria | |
| Belgium | |
| Hospital Erasme/ULB | |
| Brussels, Belgium | |
| UZ Leuven | |
| Leuven, Belgium | |
| Germany | |
| Universitat St Josef | |
| Bochum, Germany | |
| Krankenhaus Duren gem.GmbH | |
| Duren, Germany | |
| Universitatsklinik Essen | |
| Essen, Germany | |
| Universitatsklinikum | |
| Jena, Germany | |
| Universitatsklinikum Mannheim | |
| Mannheim, Germany | |
| University Hospital Munich-Grosshadem | |
| Munich, Germany | |
| Klinikum Oldenberg | |
| Oldenburg, Germany | |
| Medizinische Universitatsklinik Ulm | |
| Ulm, Germany | |
| Study Director: | dennis parenti, MD | Therakos |
More Information
| Responsible Party: | Dr Dennis Parenti, Therakos |
| ClinicalTrials.gov Identifier: | NCT00221026 History of Changes |
| Obsolete Identifiers: | NCT00105261 |
| Other Study ID Numbers: | CD-2 |
| Study First Received: | September 13, 2005 |
| Last Updated: | June 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Immunosuppressive Agents Methoxsalen |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Photosensitizing Agents Radiation-Sensitizing Agents Dermatologic Agents Therapeutic Uses |