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

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

Sponsors

Lead Sponsor: Henri Mondor University Hospital

Source 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.

Overall Status Completed
Start Date January 2007
Completion Date October 2012
Primary Completion Date June 2012
Study Type Observational
Primary Outcome
Measure Time Frame
The primary end point of the study was to assess the response rate to treatment 1 year after the first rituximab infusion. one year
Secondary Outcome
Measure Time Frame
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
Enrollment 107
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- Primary ITP

- Age > 18 years

Exclusion Criteria:

- Secondary ITP

- Age < 18 years

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Verification Date

November 2012

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Henri Mondor University Hospital

Investigator Full Name: Dr Mahévas Matthieu, MD

Investigator Title: MD

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Standard regimen

Description: Patients received the standard regimen (i.e 4 weekly infusions of 375 mg/m2)of rituximab

Label: Rheumatoid arthritis regimen

Description: Patients received the RA regimen (i.e two infusions of 1000 mg, 2 weeks apart) of rituximab

Study Design Info

Observational Model: Cohort

Time Perspective: Retrospective

Source: ClinicalTrials.gov