Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Rheumatoid Arthritis
Status:
Completed
Trial end date:
2006-11-01
Target enrollment:
Participant gender:
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.