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Plasmapheresis Before Rituximab in Cryoglobulinemia

Prevention of Rituximab Related Flare by Plasmapheresis in Cryoglobulinemic Vascularitis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04692363
Enrollment
120
Registered
2020-12-31
Start date
1999-01-01
Completion date
2021-12-31
Last updated
2020-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cryoglobulinemic Vasculitis

Keywords

Cryoglobulinemic vasculitis requiring rituximab therapy

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.

Interventions

None listed

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
comparison of frequency of occurrence of flare effects1 daycomparison of frequency of occurrence of flare effects between patients who received plasmapheresis prior to rituximab compared to patients who did not.

Secondary

MeasureTime frameDescription
evaluation of the severity of the flare effect1 dayevaluation of the severity of the flare effect
impact of known risk factors1 dayinvestigation of the impact of known risk factors for this effect
evaluation of the safety of plasmapheresis in this indication1 dayevaluation of the safety of plasmapheresis in this indication
evaluation of the efficacy of plasmapheresis on biological parameters1 dayevaluation of the efficacy of plasmapheresis on biological parameters

Countries

France

Contacts

Primary ContactCharles HERBAUX, assistant Professor
c-herbaux@chu-montpellier.fr4 67 33 83 64

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026