Granulomatosis, Wegener'sMONITUXNCT02474888
Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis
An observational study of Granulomatosis, Wegener's and Microscopic Polyangiitis, run by Centre Hospitalier Universitaire de Saint Etienne at 4 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Granulomatosis, Wegener's, Microscopic Polyangiitis
- What is being tested?
- blood specimen
- Type of treatment
- Injection or infusion
- How many people
- 28 participants
- Where
- 4 sitesFrance
- Study dates
- 15 Sep 2015to 12 Jun 2020
- 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: Granulomatosis with polyangiitis or microscopic polyangiitis (according to Chapel Hill criterions), with or without detectable ANCA
Who may be able to join
- Age > 18 years
- Granulomatosis with polyangiitis or microscopic polyangiitis (according to Chapel Hill criterions), with or without detectable ANCA
- Decision taken to start an induction regimen with rituximab
- Informed and having signed the study consent form
- If of child-bearing potential, female patients will have use an effective method of contraception during RTX (rituximab) treatment and in the 12 months following RTX treatment stop
- no-breast-feeding during RTX treatment and in the 12 months following RTX treatment stop
Who cannot join
- Other primary or secondary systemic vasculitis
- Incapacity or refusal to sign the informed consent form
- Incapacity or refusal to adhere to treatment or perform the follow-up examinations required by the study
- Allergy, documented hypersensitivity or contraindication to the medications used in the present study (corticosteroids, rituximab)
- severe active infection
- Patient with severe heart failure (stage NYHA IV) or any other unstable heart disease Pregnancy, except for cases where the expected benefit oj treatment seems to surpass the potential risks
- Patients with active hepatitis B
- Any live vaccine within four weeks prior to the first infusion of RTX
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hôpital Edouard Herriot
Lyon, 69003
Hôpital de la Croix Rousse
Lyon, 69317
CH Lyon Sud
Pierre-Bénite, 69495
CHU Saint-Etienne
Saint-Etienne, 42055
About this study
Official title: Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis : a Predictive Factor of Clinical Outcome? (MONITUX)
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.
- Being tested
- blood specimen
- Medical subject headings
- Granulomatosis with Polyangiitis, Microscopic Polyangiitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood specimenOther
blood specimen for serum rituximab level and serum anti-rituximab level at M1 and M3 after stop of induction rituximab treatment
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | 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. Receives: Other: blood specimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month after stop of rituximab induction regimen
Secondary outcomes (9)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months after stop of rituximab induction regimen
patient number with adverse event
frequency and nature of rituximab-attributed adverse events
Measured: from start of induction rituximab regimen until six monthes after stop of induction regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study start15 Sep 2015
- Primary completion12 Jun 2020
- Study completion12 Jun 2020
Why it stopped: failure of recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Granulomatosis, Wegener'sStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Theradiag
- Responsible party
- Sponsor
- Investigators
- Pascal CATHEBRAS, PHD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474888
- Sponsor's protocol ID
- 1508058
- Other IDs
- 2015-001807-29, 2015
- Acronym
- MONITUX
- Status last verified
- Nov 2020
- First submitted
- 10 Jun 2015
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis : a Predictive Factor of Clinical Outcome? (MONITUX)
- ClinicalTrials.gov ID
- NCT02474888
- Acronym / sponsor ID
- MONITUX / 1508058
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: failure of recruit
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Theradiag
- Study start
- 15 Sep 2015 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 18 Jun 2015 (estimated)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab | – | Other: blood specimena 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Granulomatosis with polyangiitis or microscopic polyangiitis (according to Chapel Hill criterions), with or without detectable ANCA
Key inclusion criteria (6 listed)
- Age > 18 years
- Granulomatosis with polyangiitis or microscopic polyangiitis (according to Chapel Hill criterions), with or without detectable ANCA
- Decision taken to start an induction regimen with rituximab
- Informed and having signed the study consent form
- If of child-bearing potential, female patients will have use an effective method of contraception during RTX (rituximab) treatment and in the 12 months following RTX treatment stop
Key exclusion criteria (8 listed)
- Other primary or secondary systemic vasculitis
- Incapacity or refusal to sign the informed consent form
- Incapacity or refusal to adhere to treatment or perform the follow-up examinations required by the study
- Allergy, documented hypersensitivity or contraindication to the medications used in the present study (corticosteroids, rituximab)
- severe active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood specimenblood specimen for serum rituximab level and serum anti-rituximab level at M1 and M3 after stop of induction rituximab treatment | Other | Rituximab |
Primary outcome
serum rituximab levels
Time frame: 1 month after stop of rituximab induction regimen
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
9 secondary outcomes
serum rituximab levels
Time frame: 3 months after stop of rituximab induction regimen
serum rituximab levels
Time frame: 6 months after stop of rituximab induction regimen
serum anti-rituximab antibodies
Time frame: 1 month after stop of rituximab induction regimen
serum anti-rituximab antibodies
Time frame: 3 months after stop of rituximab induction regimen
serum anti-rituximab antibodies
Time frame: 6 months after stop of rituximab induction regimen
Serum B lymphocytes (CD19+ cells) levels
Time frame: 1 month after stop of rituximab induction regimen
Serum B lymphocytes (CD19+ cells) levels
Time frame: 3 months after stop of rituximab induction regimen
Serum B lymphocytes (CD19+ cells) levels
Time frame: 6 months after stop of rituximab induction regimen
patient number with adverse event
Time frame: from start of induction rituximab regimen until six monthes after stop of induction regimen
Results and safety
The study was stopped early (reason given: failure of recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
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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.
Pascal CATHEBRAS, PHD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Granulomatosis, Wegener's and Microscopic Polyangiitis, run by Centre Hospitalier Universitaire de Saint Etienne at 4 sites 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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study was stopped early (reason given: failure of recruit). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum rituximab levels (time frame: 1 month after stop of rituximab induction regimen). 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 16 Nov 2020.