Plasmapheresis Before Rituximab in Cryoglobulinemia

Prevention of Rituximab Related Flare by Plasmapheresis in Cryoglobulinemic Vascularitis

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.

Study Overview

• Status: Unknown
• Conditions: Cryoglobulinemic Vasculitis

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • Uhmontpellier
    • Contact: Léa FORNERO, MD; Phone Number: 33 4 67 33 83 55; Email: l-fornero@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patient with cryoglobulinemic vasculitis requiring rituximab treatment

Description

Inclusion criteria:

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

Exclusion Criteria:

• Patient who reject the study protocol
• Patient < 18 years old

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison of frequency of occurrence of flare effects	comparison of frequency of occurrence of flare effects between patients who received plasmapheresis prior to rituximab compared to patients who did not.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluation of the severity of the flare effect	evaluation of the severity of the flare effect	1 day
impact of known risk factors	investigation of the impact of known risk factors for this effect	1 day
evaluation of the safety of plasmapheresis in this indication	evaluation of the safety of plasmapheresis in this indication	1 day
evaluation of the efficacy of plasmapheresis on biological parameters	evaluation of the efficacy of plasmapheresis on biological parameters	1 day

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 1999
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: December 30, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): December 31, 2020
• Last Update Submitted That Met QC Criteria: December 30, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Cryoglobulinemic vasculitis requiring rituximab therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Vasculitis
• Other Study ID Numbers: RECHMPL20_0683

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No