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NCT00221026 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Crohn's Disease
A Phase 2 study, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT00221026 is a Phase 2 study that has completed, run by Mallinckrodt. The registered enrollment target is 25 participants.
The verdict
NCT00221026, a Phase 2 study, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
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.
Interventions
- PROCEDURE Extracorporeal Photopheresis
- DRUG Methoxsalen +ECP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2004-12 |
| Est. Completion | 2006-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00221026
The ClinicalTrials.gov registry entry for NCT00221026 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mallinckrodt, which has 69 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Extracorporeal Photopheresis is the first listed.
NCT00221026 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00221026 about?
NCT00221026 is a clinical study titled "Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Crohn's Disease". 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)...
What is the current status of trial NCT00221026?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2004-12. Estimated completion is 2006-06.
What interventions are being tested in trial NCT00221026?
The interventions under investigation include: Extracorporeal Photopheresis (PROCEDURE), Methoxsalen +ECP (DRUG).
Who is sponsoring clinical trial NCT00221026?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
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