Cryoglobulinemic VasculitisNCT04692363
Plasmapheresis Before Rituximab in Cryoglobulinemia
An observational study of Cryoglobulinemic Vasculitis, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cryoglobulinemic Vasculitis
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 1999to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient with cryoglobulinemic vasculitis requiring rituximab treatment
Who may be able to join
- cryoglobulinemic vasculitis requiring rituximab treatment
- Patient ≥18 years old
Who cannot join
- Patient who reject the study protocol
- Patient < 18 years old
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
Léa FORNERO, MD, 4 67 33 83 55 ext. 33, l-fornero@chu-montpellier.fr
About this study
Official title: 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.
- Conditions
- Cryoglobulinemic Vasculitis
- Keywords
- Cryoglobulinemic vasculitis requiring rituximab therapy
- Medical subject headings
- Cryoglobulinemia, Familial Mixed
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (4)
evaluation of the severity of the flare effect
evaluation of the severity of the flare effect
Measured: 1 day
impact of known risk factors
investigation of the impact of known risk factors for this effect
Measured: 1 day
evaluation of the safety of plasmapheresis in this indication
evaluation of the safety of plasmapheresis in this indication
Measured: 1 day
evaluation of the efficacy of plasmapheresis on biological parameters
evaluation of the efficacy of plasmapheresis on biological parameters
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start1 Jan 1999
- Primary completion1 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryoglobulinemic VasculitisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles HERBAUX, assistant Professor, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692363
- Sponsor's protocol ID
- RECHMPL20_0683
- Status last verified
- Dec 2020
- First submitted
- 30 Dec 2020
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Rituximab Related Flare by Plasmapheresis in Cryoglobulinemic Vascularitis
- ClinicalTrials.gov ID
- NCT04692363
- Acronym / sponsor ID
- RECHMPL20_0683
- Conditions
- Cryoglobulinemic Vasculitis
- Keywords
- Cryoglobulinemic vasculitis requiring rituximab therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 1999 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient with cryoglobulinemic vasculitis requiring rituximab treatment
Key inclusion criteria (2 listed)
- cryoglobulinemic vasculitis requiring rituximab treatment
- Patient ≥18 years old
Key exclusion criteria (2 listed)
- Patient who reject the study protocol
- Patient < 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
comparison of frequency of occurrence of flare effects
Time frame: 1 day
comparison of frequency of occurrence of flare effects between patients who received plasmapheresis prior to rituximab compared to patients who did not.
4 secondary outcomes
evaluation of the severity of the flare effect
Time frame: 1 day
impact of known risk factors
Time frame: 1 day
evaluation of the safety of plasmapheresis in this indication
Time frame: 1 day
evaluation of the efficacy of plasmapheresis on biological parameters
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles HERBAUX, assistant Professor study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cryoglobulinemic Vasculitis, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charles HERBAUX, assistant Professor (4 67 33 83 64 ext. 33, c-herbaux@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of frequency of occurrence of flare effects (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2020.