Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221000
Status:
COMPLETED
Last Update Posted:
2016-10-19
First Post:
2005-09-13
Brief Title:
Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Rheumatoid Arthritis
Sponsor:
Mallinckrodt
Organization:
Mallinckrodt
Study Overview
Official Title:
A Phase II Multicenter Randomized Double-blind Sham Pheresis-controlled Study of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Rheumatoid Arthritis in Patients Who Have an Inadequate Response to Disease Modifying Antirheumatic Drugs and Biological Agents
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RA-1
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None