Urticaria Clinical Trial
Official title:
Phase I/II Open Label Evaluation of the Safety and Efficacy of Rituximab in Patients With Chronic Urticaria (The Rituximab Urticaria Study - "RUSTY")
This study is being done to find out if a drug called Rituxan (Rituximab) is safe and effective in treating people with chronic urticaria (hives) with persistent symptoms in spite of taking antihistamines.
Rituximab (Rituxan®) is a recombinant chimeric monoclonal antibody that binds to a molecule
(CD20) that is present on the surface of B lymphocytes. The product is approved for the
treatment of non-Hodgkin's lymphoma and has been investigated for the treatment of a number
of autoimmune diseases including rheumatoid arthritis (Edwards 2004) and lupus (Looney 2004,
Leandro 2002). As in most rheumatoid arthritis studies, the medication will be administered
in this study as a series of two intravenous infusions given 2 weeks apart.
Many cases of chronic urticaria (hives) are though to be driven by an autoimmune mechanism
(Kaplan 2002, Grattan 2002). It is our hypothesis that by interfering with the autoimmune
process, potentially by decreasing the levels of autoantibodies or by interfering with other
mechanisms that cause basophil and mast cell activation, improvments in signs and symptoms
will be seen.
Given the effectiveness demonstrated for Rituximab in other autoimmune conditions, we will
conduct a pilot open label investigation of 15 patients with chronic urticaria to determine
the safety and effectiveness of Rituximab in this disease. All patients will receive the
medication; there will be no placebo group in this study. Rituximab is not currently
indicated for the treatment of this condition however.
We will evaluate the safety of the Rituximab in 15 patients with urticaria as well as
studies of antibody levels and cellular function. We will also evaluate clinical outcomes
such as itch score, sleep disturbance, and quality of life. After receivng the Rituximab
treatment, we will begin to taper antihistamines and other medications used to control
urticaria symptoms.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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