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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
1000 mg at day 1 and day 15
equivalent volume total
Henri Mondor University Hospital
Créteil, France
Overall response rate (complete and partial response) in both arms
Time frame: at 1 year
Comparison in both arms of the mean cumulative doses of prednisone
Time frame: at 1 year
Comparison in both arms of the number of transfusions of packed red blood cells in both arms
Time frame: at 1 year
Comparison in both arms of the number of days in hospital
Time frame: within the first year of follow-up
Comparison in both arms of the number of patients requiring a splenectomy and/or an immunosuppressor
Time frame: during the first 12 months of follow-up
Comparison in both arm of the mortality
Time frame: at 1 year
Comparison in both arm of overall response (CR + PR)
Time frame: at 2 years
Comparison of the incidence of serious side effects in both arms
Time frame: at 1 year
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