Femme et Homme
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Extrait
The objective of this study is to explore the safety and activity of ECP treatment with UVADEX in inducing a clinical response (i.e., a CDAI decrease ≥ 100 from baseline and/or a CDAI < 150) over a 12-week period in moderately active Crohn’s disease (CDAI ≥ 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. Objective of the Substudy: The substudy will examine the immunomodulatory effects of ECP treatment of peripheral blood with UVADEX on prognostic indicators and markers of disease predisposition, biomarkers of ECP efficacy or action, and indicators of disease status.
Critère d'inclusion
- Patients with Moderately Active Crohn’s Disease Who Are Refractory or Intolerant to Immunosuppressants and/or Anti-TNF Agents