Autoimmune CytopeniaNCT07037732
Circulating B-cell, Drug and Anti-drug Antibodies Monitoring in Patients Treated With Rituximab for Autoimmune Disorders
An observational study of Autoimmune Cytopenia and Connective Tissue Disorder, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The MONIRITUX study aimed to evaluate whether monitoring (i) circulating B-cell reconstitution or (ii) serum rituximab levels could help identify relapse of autoimmune diseases in patients treated with rituximab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Cytopenia, Connective Tissue Disorder, Systemic Vasculitis
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2025to 1 Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patient who undergo rituximab treatment according to routine care and having one of the following disorder: * primary immune thrombocytopenia * primary autoimmune hemolytic anemia * systmic lupus erythematous * systemic sclerosis * rheumatoid arthritis * inflammatory myopathy * ANCA associated vasculitis * Cryoglobulinemic vasculitis
Who may be able to join
- Patient who undergo rituximab treatment according to routine care and having one of the following disorder:
- primary immune thrombocytopenia
- primary autoimmune hemolytic anemia
- systmic lupus erythematous
- systemic sclerosis
- rheumatoid arthritis
Show all 9Show fewer
- inflammatory myopathy
- ANCA associated vasculitis
- Cryoglobulinemic vasculitis
Who cannot join
- Patients undergoing multiple immunosuppressive drugs because of refractory disease or concomitant hemopathy or malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu de Nice
Nice, Alpes Maritimes, 06000
MICHAEL LEVRAUT, 04.92.03.54.44 ext. + 33, levraut.m@chu-nice.fr
: levraut.m@chu-nice.fr Levraut, 04.92.03.54.44 ext. +33, levraut.m@chu-nice.fr
About this study
Official title: Circulating B-cell, Drug and Anti-drug Antibodies Monitoring in Patients Treated With Rituximab for Autoimmune Disorders : the MONIRITUX Study
The MONIRITUX study aimed to evaluate whether monitoring (i) circulating B-cell reconstitution or (ii) serum rituximab levels could help identify relapse of autoimmune diseases in patients treated with rituximab. Retrospective data suggest that B-cell reconstitution or the appearance of anti-drug antibodies are associated with rituximab's failure to prevent relapses (i.e. rheumatoid arthritis, systemic lupus erythematosus, autoimmune cytopenia...). According to the routine care provided by our institution, patients undergoing rituximab therapy are monitored every three months during the first year after treatment induction and every six months thereafter. At each clinical visit, a blood test is performed to quantify total gammaglobulins, IgG and CD19+ cells (along with other tests depending on the disease). This study will use the remaining blood in the tubes from routine care to quantify CD27+ and CD38+ B cells, as well as serum rituximab and anti-rituximab antibodies, during the first year of follow-up. The primary outcome will be to identify risk factors for clinical relapse according to circulating B-cell or rituximab status.
- Medical subject headings
- Connective Tissue Diseases, Systemic Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Autoimmune cytopenia (immune thrombocytopenia or hemolytic anemia) | Blood CD19+, CD27+, and CD38+ B-cell reconstitution, circulanting rituximab level or the presence of circulating anti-rituximab antibodies will be compared in patients experiencing clinical relapse and those who will remain stable over time. | |
| Connective tissu disorder (SLE, myopathie, RA…) | Blood CD19+, CD27+, and CD38+ B-cell reconstitution, circulanting rituximab level or the presence of circulating anti-rituximab antibodies will be compared in patients experiencing clinical relapse and those who will remain stable over time. | |
| Systemic vasculitis (ANCA, essential cryoglobulinemia) | Blood CD19+, CD27+, and CD38+ B-cell reconstitution, circulanting rituximab level or the presence of circulating anti-rituximab antibodies will be compared in patients experiencing clinical relapse and those who will remain stable over time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients with (Immune Thrombocytopenia) ITP
Hematologic relapse described as a drop in platelet count below 20 G/L following a remission phase of at least 3 months with platelet count greater than 50 G/L.
Measured: At each consultation during 5 years
Patients with AIHA Autoimmune Hemolytic Anemia.
Hematologic relapse described as a drop in hemoglobin level below 10 g/dL (with a lost of at least 2 g/dL from baseline) in association with hemolysis after e remission of at least 3 months
Measured: At each consultation during 5 years
Patients with inflammatory myopathy
Clinical relase defined as a confirmed muscular (myalgia associated with at least one from the following : increase CK levels, new or worsening electromyography, new or worsening muscle inflammation on MRI), joint or pulmonary new symptoms related to myositis
Measured: At each consultation during 5 years
Patients with systemic lupus erythematous :
Clinical relapse defined as an increase by 4 points in the SLEDAI (systemic lupus erythematous disease activity index) score
Measured: At each consultation during 5 years
Patients with systemic vasculitis
Clinical relapse defined as an increase by 1 points in the Birmingham vasculitis (BVAS) score
Measured: At each consultation during 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Jun 2025
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune CytopeniaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037732
- Sponsor's protocol ID
- 25Immuno01
- Status last verified
- May 2025
- First submitted
- 23 May 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating B-cell, Drug and Anti-drug Antibodies Monitoring in Patients Treated With Rituximab for Autoimmune Disorders : the MONIRITUX Study
- ClinicalTrials.gov ID
- NCT07037732
- Acronym / sponsor ID
- 25Immuno01
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 25 Jun 2025 (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.
The MONIRITUX study aimed to evaluate whether monitoring (i) circulating B-cell reconstitution or (ii) serum rituximab levels could help identify relapse of autoimmune diseases in patients treated with rituximab. Retrospective data suggest that B-cell reconstitution or the appearance of anti-drug antibodies are associated with rituximab's failure to prevent relapses (i.e. rheumatoid arthritis, systemic lupus erythematosus, autoimmune cytopenia...). According to the routine care provided by our institution, patients undergoing rituximab therapy are monitored every three months during the first year after treatment induction and every six months thereafter. At each clinical visit, a blood test is performed to quantify total gammaglobulins, IgG and CD19+ cells (along with other tests depending on the disease). This study will use the remaining blood in the tubes from routine care to quantify CD27+ and CD38+ B cells, as well as serum rituximab and anti-rituximab antibodies, during the first year of follow-up. The primary outcome will be to identify risk factors for clinical relapse according to circulating B-cell or rituximab status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Autoimmune cytopenia (immune thrombocytopenia or hemolytic anemia) | – | –Blood CD19+, CD27+, and CD38+ B-cell reconstitution, circulanting rituximab level or the presence of circulating anti-rituximab antibodies will be compared in patients experiencing clinical relapse and those who will remain stable over time. |
| Connective tissu disorder (SLE, myopathie, RA…) | – | –Blood CD19+, CD27+, and CD38+ B-cell reconstitution, circulanting rituximab level or the presence of circulating anti-rituximab antibodies will be compared in patients experiencing clinical relapse and those who will remain stable over time. |
| Systemic vasculitis (ANCA, essential cryoglobulinemia) | – | –Blood CD19+, CD27+, and CD38+ B-cell reconstitution, circulanting rituximab level or the presence of circulating anti-rituximab antibodies will be compared in patients experiencing clinical relapse and those who will remain stable over time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who undergo rituximab treatment according to routine care and having one of the following disorder: * primary immune thrombocytopenia * primary autoimmune hemolytic anemia * systmic lupus erythematous * systemic sclerosis * rheumatoid arthritis * inflammatory myopathy * ANCA associated vasculitis * Cryoglobulinemic vasculitis
Key inclusion criteria (9 listed)
- Patient who undergo rituximab treatment according to routine care and having one of the following disorder:
- primary immune thrombocytopenia
- primary autoimmune hemolytic anemia
- systmic lupus erythematous
- systemic sclerosis
Key exclusion criteria (1 listed)
- Patients undergoing multiple immunosuppressive drugs because of refractory disease or concomitant hemopathy or malignancy
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
Patients with (Immune Thrombocytopenia) ITP
Time frame: At each consultation during 5 years
Hematologic relapse described as a drop in platelet count below 20 G/L following a remission phase of at least 3 months with platelet count greater than 50 G/L.
Patients with AIHA Autoimmune Hemolytic Anemia.
Time frame: At each consultation during 5 years
Hematologic relapse described as a drop in hemoglobin level below 10 g/dL (with a lost of at least 2 g/dL from baseline) in association with hemolysis after e remission of at least 3 months
Patients with inflammatory myopathy
Time frame: At each consultation during 5 years
Clinical relase defined as a confirmed muscular (myalgia associated with at least one from the following : increase CK levels, new or worsening electromyography, new or worsening muscle inflammation on MRI), joint or pulmonary new symptoms related to myositis
Patients with systemic lupus erythematous :
Time frame: At each consultation during 5 years
Clinical relapse defined as an increase by 4 points in the SLEDAI (systemic lupus erythematous disease activity index) score
Patients with systemic vasculitis
Time frame: At each consultation during 5 years
Clinical relapse defined as an increase by 1 points in the Birmingham vasculitis (BVAS) score
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
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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.
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 Autoimmune Cytopenia and Connective Tissue Disorder, run by Centre Hospitalier Universitaire de Nice 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 9 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 25 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MICHAEL Levraut (04.92.03.54.44 ext. + 33, levraut.m@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients with (Immune Thrombocytopenia) ITP (time frame: At each consultation during 5 years). The study lists 5 primary outcomes in all. 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 25 Jun 2025.