Warm Autoimmune Hemolytic Anemia Clinical Trial
Official title:
Rituximab in Adult's Warm Auto-Immune Hemolytic Anemia : a Phase III, Double-bind, Randomised Placebo-controlled Trial
The hypothesis based on retrospective data is that, the rate of overall response-rate (PR + CR) at 1 year will be much higher in the rituximab arm (80%) than in the placebo arm (20%).Thirty four patients (17 in each arm) will be include (amendment n°6 - 15/10/2013) over a 3 year period (amendment n°3 - 11/12/2012).
The primary aim of the study is to assess the efficacy (overall response rate at 1 year) of
rituximab (an anti-CD20 monoclonal antibody) in AIHA due to warm autoantibody when
administered at the initial phase of the disease. All eligible patents with a newly diagnosed
AIHA (within 6 weeks after diagnosis) will be treated by corticosteroids at standard dose
(prednisone 1 mg/kg/day) and will be randomized into 2 arms: Rituximab or placebo 1000 mg on
days 1 and 15 in a 1/1 ratio. As soon as at least a partial remission (PR) of AIHA will be
achieved, the daily dose of prednisone will be tapered following the rules provided by the
protocol.
The hypothesis based on retrospective data is that, the rate of overall response-rate (PR +
CR) at 1 year will be much higher in the rituximab arm (80%) than in the placebo arm
(20%).Thirty four patients (17 in each arm) will be include (amendment n°6 - 15/10/2013) over
a 3 year period (amendment n°3 - 11/12/2012).
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