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NCT00221000 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Rheumatoid Arthritis
A Phase 2 study, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 2
- Development phase
- 86
- Enrollment target
NCT00221000 is a Phase 2 study that has completed, run by Mallinckrodt. The registered enrollment target is 86 participants.
The verdict
NCT00221000, a Phase 2 study, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 86 participants
- Enrollment target
Study Summary
Rheumatoid arthritis (RA) is a systemic autoimmune inflammatory disorder that can cause substantial pain and joint tenderness, significant joint damage, and serious disability. The treatment goals are minimization of the signs and symptoms of the disease, and the reduction of irreversible joint damage. As the understanding of the pathophysiological mechanisms underlying RA is elucidated, the opportunity to target specific inflammatory processes with new therapies has improved. Rheumatoid arthritis is a T cell-mediated autoimmune disease and there are various therapies, including newer experimental therapies, which target either the activation of T cells or the neutralization of their effector mechanisms. These newer therapies have shown benefit in human and animal models of RA. Extracorporeal photoimmune therapy (ECP) has been shown to be safe and effective in the palliative treatment of the skin manifestations of cutaneous T cell lymphoma. Experimental studies have also demonstrated activity of ECP treatment in several T cell mediated diseases including graft versus-host disease, rejection after organ transplantation, and selected autoimmune diseases. This study will evaluate a cell-based therapy (ECP) in patients who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs) and biological agents to determine if ECP treatment can reduce the signs and symptoms of RA in this refractory patient population.
Interventions
- PROCEDURE Extracorporeal Photopheresis
- DRUG Methoxsalen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2003-08 |
| Est. Completion | 2006-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00221000
The ClinicalTrials.gov registry entry for NCT00221000 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 86 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.
NCT00221000 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00221000 about?
NCT00221000 is a clinical study titled "Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Rheumatoid Arthritis". Rheumatoid arthritis (RA) is a systemic autoimmune inflammatory disorder that can cause substantial pain and joint tenderness, significant joint damage, and serious disability. The treatment goals are minimization of the signs and symptoms of the disease, and the reduction of irreversible joint dama...
What is the current status of trial NCT00221000?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 86 participants. The study started on 2003-08. Estimated completion is 2006-11.
What interventions are being tested in trial NCT00221000?
The interventions under investigation include: Extracorporeal Photopheresis (PROCEDURE), Methoxsalen (DRUG).
Who is sponsoring clinical trial NCT00221000?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
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