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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: Completed Phase 2 study, sponsored by Mallinckrodt.
NCT00221026 is a Phase 2 study that has completed, run by Mallinckrodt. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The CDAI is a questionaire giving the change of disease acitvity.This study wil llook or a decrease in CDAI score of at least 100.
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 |
What the finished NCT00221026 record still lists
NCT00221026 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Extracorporeal Photopheresis is the first listed.
NCT00221026 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00221026's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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