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Plasmapheresis Before Rituximab in Cryoglobulinemia

NCT ID: NCT04692363

Last Updated: 2020-12-31

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

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-01-01

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cryoglobulinemic Vasculitis

Keywords

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Cryoglobulinemic vasculitis requiring rituximab therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* cryoglobulinemic vasculitis requiring rituximab treatment
* Patient ≥18 years old

Exclusion Criteria

* Patient who reject the study protocol
* Patient \< 18 years old
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles HERBAUX, assistant Professor

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

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Uhmontpellier

Montpellier, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Charles HERBAUX, assistant Professor

Role: CONTACT

Phone: 4 67 33 83 64

Email: [email protected]

Facility Contacts

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Léa FORNERO, MD

Role: primary

Other Identifiers

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RECHMPL20_0683

Identifier Type: -

Identifier Source: org_study_id