Plasmapheresis Before Rituximab in Cryoglobulinemia

Cryoglobulinemic Vasculitis Clinical Trial

Official title:

Prevention of Rituximab Related Flare by Plasmapheresis in Cryoglobulinemic Vascularitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04692363
• Other study ID #: RECHMPL20_0683
• Status: Recruiting
• Start date: January 1, 1999
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2020
• Source: University Hospital, Montpellier
• Contact: Charles HERBAUX, assistant Professor
• Phone: 4 67 33 83 64
• Email: c-herbaux[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• cryoglobulinemic vasculitis requiring rituximab treatment

• Patient =18 years old

Exclusion Criteria:

• Patient who reject the study protocol

• Patient < 18 years old

Related Conditions & MeSH terms

• Cryoglobulinemic Vasculitis
• Vasculitis

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	evaluation of the severity of the flare effect	evaluation of the severity of the flare effect	1 day
Secondary	impact of known risk factors	investigation of the impact of known risk factors for this effect	1 day
Secondary	evaluation of the safety of plasmapheresis in this indication	evaluation of the safety of plasmapheresis in this indication	1 day
Secondary	evaluation of the efficacy of plasmapheresis on biological parameters	evaluation of the efficacy of plasmapheresis on biological parameters	1 day