Plasmapheresis Before Rituximab in Cryoglobulinemia
- Conditions
- Cryoglobulinemic Vasculitis
- Registration Number
- NCT04692363
- Lead Sponsor
- University Hospital, Montpellier
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
Not provided
- Patient who reject the study protocol
- Patient < 18 years old
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method evaluation of the severity of the flare effect 1 day evaluation of the severity of the flare effect
impact of known risk factors 1 day investigation of the impact of known risk factors for this effect
evaluation of the safety of plasmapheresis in this indication 1 day evaluation of the safety of plasmapheresis in this indication
evaluation of the efficacy of plasmapheresis on biological parameters 1 day evaluation of the efficacy of plasmapheresis on biological parameters
Trial Locations
- Locations (1)
Uhmontpellier
馃嚝馃嚪Montpellier, France