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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

Sponsor
Henri Mondor University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01727232
Collaborator
(none)
107
Enrollment
69
Duration (Months)

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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 :
    Jan 1, 2007
    Actual Primary Completion Date :
    Jun 1, 2012
    Actual Study Completion Date :
    Oct 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    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. [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. [3 months, one year, last follow-up]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Primary ITP

    • Age > 18 years

    Exclusion Criteria:

    • Secondary ITP

    • Age < 18 years

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Henri Mondor University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Mahévas Matthieu, MD, MD, Henri Mondor University Hospital
    ClinicalTrials.gov Identifier:
    NCT01727232
    Other Study ID Numbers:
    • Mondor-Rituxcompare
    First Posted:
    Nov 15, 2012
    Last Update Posted:
    Nov 15, 2012
    Last Verified:
    Nov 1, 2012
    Keywords provided by Dr Mahévas Matthieu, MD, MD, Henri Mondor University Hospital
    ITP
    Rituximab
    Efficacy
    Anti-CD20
    Regimen
    Additional relevant MeSH terms:
    Thrombocytopenia
    Purpura, Thrombocytopenic, Idiopathic

    Study Results

    No Results Posted as of Nov 15, 2012