An observational study in Granulomatosis, Wegener's and Microscopic Polyangiitis, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Terminated at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-16.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Observational
The aim of the investigators' study is to evaluate whether monitoring serum rituximab levels could be an interesting tool in the follow-up of ANCA-associated vasculitis patients.
All consecutive patients, hospitalized for a new diagnosis of ANCA-associated vasculitis or the relapse of a known ANCA-associated vasculitis, in which the decision to start an induction regimen with rituximab has been taken, will be included.
Serum rituximab levels (along with serum anti-rituximab antibodies levels) will be determined (at M+1 and M+3) and the correlation with clinical outcome at M+6 will be analyzed.
104 studies on the registry are indexed under Granulomatosis with Polyangiitis; 16 are open to participants now.
This study's enrollment of 28 is below the median of 100 across 32 observational studies indexed under Granulomatosis with Polyangiitis.
Browse Granulomatosis with Polyangiitis studies →Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Granulomatosis with polyangiitis or microscopic polyangiitis (according to Chapel Hill criterions), with or without detectable ANCA
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
a classical induction regimen with rituximab (decision taken before inclusion), implying an infusion of 375mg/m² per week, for 4 consecutive weeks (from week -3 until week 0) with blood specimen.
Other: blood specimen
blood specimen for serum rituximab level and serum anti-rituximab level at M1 and M3 after stop of induction rituximab treatment
serum rituximab levels
rituximab level comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score \> 0, 6 months after stop of induction regimen
Time frame: 1 month after stop of rituximab induction regimen
serum rituximab levels
rituximab level comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score \> 0 six months after stop of induction regimen
Time frame: 3 months after stop of rituximab induction regimen
serum rituximab levels
rituximab level comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score \> 0 six months after stop of induction regimen
Time frame: 6 months after stop of rituximab induction regimen
serum anti-rituximab antibodies
serum anti-rituximab antibodies level comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score \> 0 six months after stop of induction regimen
Time frame: 1 month after stop of rituximab induction regimen
serum anti-rituximab antibodies
serum anti-rituximab antibodies level comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score \> 0 six months after stop of induction regimen
Time frame: 3 months after stop of rituximab induction regimen
serum anti-rituximab antibodies
serum anti-rituximab antibodies level comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score \> 0 six months after stop of induction regimen
Time frame: 6 months after stop of rituximab induction regimen
Serum B lymphocytes (CD19+ cells) levels
Serum B lymphocytes (CD19+ cells) levels comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score \> 0 six months after stop of induction regimen
Time frame: 1 month after stop of rituximab induction regimen
Serum B lymphocytes (CD19+ cells) levels
Serum B lymphocytes (CD19+ cells) levels comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score \> 0 six months after stop of induction regimen
Time frame: 3 months after stop of rituximab induction regimen
Serum B lymphocytes (CD19+ cells) levels
Serum B lymphocytes (CD19+ cells) levels comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score \> 0 six months after stop of induction regimen
Time frame: 6 months after stop of rituximab induction regimen
patient number with adverse event
frequency and nature of rituximab-attributed adverse events
Time frame: from start of induction rituximab regimen until six monthes after stop of induction regimen
This study is terminated, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Granulomatosis with Polyangiitis →
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