Efficacy and Safety of Rituximab Given at Fixed Dose (1000 mg on Days 1 and 15) Compared to the Standard Regimen in Adult's Immune Thrombocytopenia
- Conditions
- Primary Immune Thrombocytopenia
- Registration Number
- NCT01727232
- Lead Sponsor
- Henri Mondor University Hospital
- Brief Summary
The aim of this large French multicentric retrospective study was to compare the efficacy and safety of two (the standard and the Rheumatoid arthritis) rituximab regimens in adult's immune thrombocytopenia .
- Detailed Description
Every adult (age ≥ 18 years) seen in one of the 3 participating centre (dijon, Marseille, Mondor) over a 7-year period (2005-2012) with a definite diagnosis of primary ITP according to the American Society Hematology guidelines who received RTX regardless the regimen could be included.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 107
- Primary ITP
- Age > 18 years
- Secondary ITP
- Age < 18 years
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary end point of the study was to assess the response rate to treatment 1 year after the first rituximab infusion. one year A complete response (CR) was defined as a platelet count \>100 x 109/l and a response (R): by a platelet count \>30 x 109/l with a least a doubling of the baseline value without any rescue intervention within 8 weeks before assessment, and no response (NR) was defined as a platelet count lower than 30 x 109/
- Secondary Outcome Measures
Name Time Method The response rate 3months, and at the last follow-up after the first rituximab infusion. Variable associated with RTX response. 3 months, one year, last follow-up