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

NCT ID: NCT01727232

Last Updated: 2012-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2012-10-31

Brief Summary

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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

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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.

Conditions

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Primary Immune Thrombocytopenia

Keywords

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ITP Rituximab Efficacy Anti-CD20 Regimen

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Standard regimen

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

No interventions assigned to this group

Rheumatoid arthritis regimen

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Primary ITP
* Age \> 18 years

Exclusion Criteria

* Secondary ITP
* Age \< 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henri Mondor University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr Mahévas Matthieu, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Mondor-Rituxcompare

Identifier Type: -

Identifier Source: org_study_id