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

November 12, 2012 updated by: Dr Mahévas Matthieu, MD, Henri Mondor University Hospital
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 .

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary ITP patients treated with standard or RA regimen were retrospectively included in the observationnal study.

Description

Inclusion Criteria:

  • Primary ITP
  • Age > 18 years

Exclusion Criteria:

  • Secondary ITP
  • Age < 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Standard regimen
Patients received the standard regimen (i.e 4 weekly infusions of 375 mg/m2)of rituximab
Rheumatoid arthritis regimen
Patients received the RA regimen (i.e two infusions of 1000 mg, 2 weeks apart) of rituximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary end point of the study was to assess the response rate to treatment 1 year after the first rituximab infusion.
Time Frame: 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/
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
The response rate 3months, and at the last follow-up after the first rituximab infusion. Variable associated with RTX response.
Time Frame: 3 months, one year, last follow-up
3 months, one year, last follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henri Mondor University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

November 12, 2012

First Submitted That Met QC Criteria

November 12, 2012

First Posted (Estimate)

November 15, 2012

Study Record Updates

Last Update Posted (Estimate)

November 15, 2012

Last Update Submitted That Met QC Criteria

November 12, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mondor-Rituxcompare

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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