Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Rheumatoid Arthritis (RA-1)
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|ClinicalTrials.gov Identifier: NCT00221000|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : October 19, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: Methoxsalen Procedure: Extracorporeal Photopheresis||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||August 2003|
|Actual Primary Completion Date :||October 2006|
|Actual Study Completion Date :||November 2006|
- ACR 20 [ Time Frame: week 24 and week 28 ]At least a 20% improvement of ACR 20 from baseline
- ACR 50 [ Time Frame: week 24 and week 28 ]Improvement of at least 50% from baseline on ACR 50
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00221000
Show 32 Study Locations
|Principal Investigator:||EDWARD KEYSTONE, MD||Rebecca MacDonald Centre for Arthritis|