NCT04692363

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
22 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

December 31, 2020

Status Verified

December 1, 2020

Enrollment Period

22.9 years

First QC Date

December 30, 2020

Last Update Submit

December 30, 2020

Conditions

Cryoglobulinemic Vasculitis

Keywords

Cryoglobulinemic vasculitis requiring rituximab therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • evaluation of the severity of the flare effect

    1 day

  • impact of known risk factors

    1 day

  • evaluation of the safety of plasmapheresis in this indication

    1 day

  • evaluation of the efficacy of plasmapheresis on biological parameters

    1 day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patient with cryoglobulinemic vasculitis requiring rituximab treatment

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Cryoglobulinemia, Familial Mixed

Study Officials

  • Charles HERBAUX, assistant Professor

    University Hospital, Montpellier

    STUDY DIRECTOR

Central Study Contacts

Charles HERBAUX, assistant Professor

CONTACT

4 67 33 83 64c-herbaux@chu-montpellier.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2020

First Posted

December 31, 2020

Study Start

January 1, 1999

Primary Completion

December 1, 2021

Study Completion

December 31, 2021

Last Updated

December 31, 2020

Record last verified: 2020-12

Locations

FR(1)