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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01727232
Recruitment Status : Completed
First Posted : November 15, 2012
Last Update Posted : November 15, 2012
Information provided by (Responsible Party):
Dr Mahévas Matthieu, MD, 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 .

Condition or disease
Primary 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.

Study Type : Observational
Actual Enrollment : 107 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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
Study Start Date : January 2007
Actual Primary Completion Date : June 2012
Actual Study Completion Date : October 2012

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

Primary Outcome Measures :
  1. 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/

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary ITP patients treated with standard or RA regimen were retrospectively included in the observationnal study.

Inclusion Criteria:

  • Primary ITP
  • Age > 18 years

Exclusion Criteria:

  • Secondary ITP
  • Age < 18 years

Responsible Party: Dr Mahévas Matthieu, MD, MD, Henri Mondor University Hospital Identifier: NCT01727232     History of Changes
Other Study ID Numbers: Mondor-Rituxcompare
First Posted: November 15, 2012    Key Record Dates
Last Update Posted: November 15, 2012
Last Verified: November 2012

Keywords provided by Dr Mahévas Matthieu, MD, Henri Mondor University Hospital:

Additional relevant MeSH terms:
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents