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Sponsored by: |
Therakos |
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Information provided by: | Therakos |
ClinicalTrials.gov Identifier: | NCT00221026 |
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 Procedure: Extracorporeal Photopheresis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients are considered to have failed treatment with these medications if they are refractory or intolerant to their use, regardless of prior or ongoing treatment with corticosteroids.
Refractoriness to immunosuppressant therapies and/or anti-TNF agents is defined as patients continuing to have active Crohn’s disease despite prior or current treatment with one or more of the following: AZA 2-3 mg/kg/day for 12 weeks; 6-MP 1.0-1.5 mg/kg/day for 12 weeks; MTX 25 mg/wk for 8 weeks; infliximab greater than or equal to 5 mg/kg for 4 weeks (at least one infusion); adalimumab greater than or equal to 40 mg subcutaneous (SC) for 4 weeks (at least two injections).
Intolerance to immunosuppressants and/or anti-TNF agents is defined as patients experiencing related side effects to one or more of the agents listed above that limit or proscribe their use (e.g. leukopenia, hepatitis, infusion reactions, or drug-induced lupus) at doses needed to adequately control the activity of their Crohn’s disease.
Exclusion Criteria:
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 | |
Medizinische Universitatsklinik Ulm | |
Ulm, 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 | |
Universitat St Josef | |
Bochum, Germany |
Study ID Numbers: | CD-2 |
Study First Received: | September 13, 2005 |
Last Updated: | January 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00221026 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Crohn's Disease Ileitis Gastrointestinal Diseases Enteritis Inflammatory Bowel Diseases Intestinal Diseases Ileal Diseases |
Immunosuppressive Agents Photosensitizing Agents Digestive System Diseases Radiation-Sensitizing Agents Methoxsalen Crohn Disease Gastroenteritis |
Ileitis Gastrointestinal Diseases Enteritis Physiological Effects of Drugs Inflammatory Bowel Diseases Intestinal Diseases Ileal Diseases Pharmacologic Actions |
Photosensitizing Agents Digestive System Diseases Radiation-Sensitizing Agents Methoxsalen Therapeutic Uses Crohn Disease Gastroenteritis Dermatologic Agents |