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Plasmapheresis Before Rituximab in Cryoglobulinemia

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Recruiting
CT.gov ID
NCT04692363
Collaborator
(none)
120
Enrollment
1
Location
276
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Initial worsening following initiation of rituximab therapy in patients with cryoglobulinemic vasculitis was described in 3.6% of cases. This worsening is often a serious condition, with high levels of mortality.

The objective of our study is to evaluate the efficacy of preventive plasmapheresis prior to the introduction of rituximab performed in Montpellier France since 2013 by assessing the frequency and severity of this flare effect in these patients compared to those reported in the literature.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Prevention of Rituximab Related Flare by Plasmapheresis in Cryoglobulinemic Vascularitis
    Actual Study Start Date :
    Jan 1, 1999
    Anticipated Primary Completion Date :
    Dec 1, 2021
    Anticipated Study Completion Date :
    Dec 31, 2021

    Outcome Measures

    Primary Outcome Measures

    1. comparison of frequency of occurrence of flare effects [1 day]

      comparison of frequency of occurrence of flare effects between patients who received plasmapheresis prior to rituximab compared to patients who did not.

    Secondary Outcome Measures

    1. evaluation of the severity of the flare effect [1 day]

      evaluation of the severity of the flare effect

    2. impact of known risk factors [1 day]

      investigation of the impact of known risk factors for this effect

    3. evaluation of the safety of plasmapheresis in this indication [1 day]

      evaluation of the safety of plasmapheresis in this indication

    4. evaluation of the efficacy of plasmapheresis on biological parameters [1 day]

      evaluation of the efficacy of plasmapheresis on biological parameters

    Eligibility Criteria

    Criteria

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

    • cryoglobulinemic vasculitis requiring rituximab treatment

    • Patient ≥18 years old

    Exclusion Criteria:

    • Patient who reject the study protocol

    • Patient < 18 years old

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uhmontpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Study Director: Charles HERBAUX, assistant Professor, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT04692363
    Other Study ID Numbers:
    • RECHMPL20_0683
    First Posted:
    Dec 31, 2020
    Last Update Posted:
    Dec 31, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    Cryoglobulinemic vasculitis requiring rituximab therapy
    Additional relevant MeSH terms:
    Vasculitis

    Study Results

    No Results Posted as of Dec 31, 2020