Rheumatoid Arthritis (RA)PROLOD-RANCT06933134
Prospective Validation of a Pharmacological Biomarker for Low-Dose Rituximab in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis (RA), run by University Hospital, Tours at 1 site in France.
Trial summary
Evaluation of the prediction of clinical response to rituximab at a dose of 1000 mg once using a pharmacological model including several pharmacokinetic and pharmacodynamic parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 23 Apr 2026to Nov 2028
- 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: Adult patients with a diagnosis of rheumatoid arthritis meeting ACR/EULAR 2010 criteria on standard-dose rituximab with a good clinical response.
Who may be able to join
- . Age ≥ 18 years
- Diagnosis of rheumatoid arthritis meeting ACR/EULAR 2010 criteria.
- Candidates for a Low Dose regimen: on standard dose rituximab and with a good clinical response according to the referring rheumatologist. No maximum duration of use of standard-dose rituximab has been defined.
- In the case of co-prescription of csDMARDs (Methotrexate, Leflunomide, Salazopyrine, Plaquenil), the dose must have been stable for 3 months.
- If corticosteroids are co-prescribed, the dose should be ≤ 10 mg/d and stable for 3 months.
Who cannot join
- Other associated targeted disease-modifying therapy
- Sjögren's syndrome or other associated inflammatory rheumatism
- Fibromyalgia or other pathology having an impact on the assessment of disease activity
- Any active haematological disease affecting lymphocytes (chronic lymphocytic leukaemia, Hodgkin's and non-Hodgkin's lymphomas, lymphoplasmacytic lymphoma, T lymphoma).
- Opposition to data processing
- No inclusion of persons covered by articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the Public Health Code (e.g. minors, protected adults, etc.).
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
University hospital
Tours, 37044
Simon BRUNET, 247475917 ext. +33, simon.brunet@chu-tours.fr
About this study
Evaluation of the prediction of clinical response to rituximab at a dose of 1000 mg once using a pharmacological model including several pharmacokinetic and pharmacodynamic parameters.
Read the detailed description
Rituximab is an anti-CD20 monoclonal antibody which is effective in RA. The dose indicated in the marketing authorisation is 1000 mg twice per cycle. However, rituximab is associated with adverse events, and more specifically the risk of infection, which seems to be dose-dependent. The dose of 1000 mg once a cycle has been evaluated and is non-inferior for maintenance treatment. Lower doses than 1000 mg once could also be sufficient, but there is a lack of predictive criteria to guide clinicians in their search for the minimal effective dose for a given patient.
In our center, a PK-PD model including several parameters (body surface area, serum IgG concentration, residual rituximab concentrations and CD4+ T-cell count) has enabled to quantify part of the concentration-effect relationship of rituximab in this indication and at standard dose (1000 mg twice at 15-day intervals). On the basis of this model, a model for predicting clinical response has been developed.with reliable prediction of clinical response.
The aim of this study is to apply this model to patients receiving low-dose rituximab (1000 mg once per cycle) and to evaluate the prediction of clinical response to low-dose rituximab using this model.
Correlation and coefficient of determination between DAS28-CRP observed 6 months after a second low-dose cycle and DAS-28 predicted by a PK-PD model taking into account gender, body surface area, IgG concentration, rituximab concentration and CD4 T-cell count.
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- pharmacological biomarker, rituximab, retreatment, low dose
- Medical subject headings
- Arthritis, Rheumatoid
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 |
|---|---|---|
| Patients group | The number of subjects required for our study was set at 30. It's a single-centre prospective non-interventional descriptive study. Patients will be followed every 3 months during 12 months. At inclusion, they will receive a first cycle of low-dose rituximab followed by a second cycle at 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed Disease Activity Score(DAS) 28-CRP
DAS28-CRP measured by the clinician 6 months after the second cycle of rituximab
Measured: 6 months after a second low-dose cycle
Calculated DAS28-CRP
DAS28-CRP calculated 6 months after the second cycle of rituximab by a PK-PD model, taking into account gender, body surface area in m2, IgG concentration, rituximab concentration and CD4+ T-cell count
Measured: 6 months after a second low-dose cycle
Secondary outcomes (5)
Prevalence observed DAS28-CRP
- Percentage of patients with a DAS28-CRP < 3.2 at 3 months and 6 months of the first and second cycle of low-dose rituximab
- Percentage of patients with a DAS28-CRP <2.6 at 3 months and 6 months of the first and second cycle of low-dose rituximab
Measured: 3 months and 6 months of the first and second cycle of low-dose rituximab
Description of events
Description of moderate and severe infectious events. Description of adverse events occurring during infusions
Measured: From enrolment to 12 months
prevalence calculated DAS28-CRP
- percentage of patients with a predicted DAS 28 CRP < 3.2 at 6 months of the second cycle of low-dose rituximab
- percentage of patients with a predicted DAS 28 CRP < 2.6 at 6 months of the second cycle of low-dose rituximab
Measured: 6 months of the second cycle of low-dose rituximab
CD4 T cell count
T cell count (< 500/mm3)
Measured: 6 months of a second cycle of low dose rituximab.
immunoglobulin G level
immunoglobulin G level (< 6 g/L)
Measured: 6 months of a second cycle of low dose rituximab.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start23 Apr 2026
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933134
- Sponsor's protocol ID
- DR230304 - PROLOD-RA
- Acronym
- PROLOD-RA
- Status last verified
- Apr 2026
- First submitted
- 25 Mar 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of a Pharmacological Biomarker for Low-Dose Rituximab in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06933134
- Acronym / sponsor ID
- PROLOD-RA / DR230304 - PROLOD-RA
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- pharmacological biomarker, rituximab, retreatment, low dose
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 18 Apr 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.
Evaluation of the prediction of clinical response to rituximab at a dose of 1000 mg once using a pharmacological model including several pharmacokinetic and pharmacodynamic parameters.
Detailed description
Rituximab is an anti-CD20 monoclonal antibody which is effective in RA. The dose indicated in the marketing authorisation is 1000 mg twice per cycle. However, rituximab is associated with adverse events, and more specifically the risk of infection, which seems to be dose-dependent. The dose of 1000 mg once a cycle has been evaluated and is non-inferior for maintenance treatment. Lower doses than 1000 mg once could also be sufficient, but there is a lack of predictive criteria to guide clinicians in their search for the minimal effective dose for a given patient.
In our center, a PK-PD model including several parameters (body surface area, serum IgG concentration, residual rituximab concentrations and CD4+ T-cell count) has enabled to quantify part of the concentration-effect relationship of rituximab in this indication and at standard dose (1000 mg twice at 15-day intervals). On the basis of this model, a model for predicting clinical response has been developed.with reliable prediction of clinical response.
The aim of this study is to apply this model to patients receiving low-dose rituximab (1000 mg once per cycle) and to evaluate the prediction of clinical response to low-dose rituximab using this model.
Correlation and coefficient of determination between DAS28-CRP observed 6 months after a second low-dose cycle and DAS-28 predicted by a PK-PD model taking into account gender, body surface area, IgG concentration, rituximab concentration and CD4 T-cell count.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients group | – | –The number of subjects required for our study was set at 30. It's a single-centre prospective non-interventional descriptive study. Patients will be followed every 3 months during 12 months. At inclusion, they will receive a first cycle of low-dose rituximab followed by a second cycle at 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a diagnosis of rheumatoid arthritis meeting ACR/EULAR 2010 criteria on standard-dose rituximab with a good clinical response.
Key inclusion criteria (5 listed)
- . Age ≥ 18 years
- Diagnosis of rheumatoid arthritis meeting ACR/EULAR 2010 criteria.
- Candidates for a Low Dose regimen: on standard dose rituximab and with a good clinical response according to the referring rheumatologist. No maximum duration of use of standard-dose rituximab has been defined.
- In the case of co-prescription of csDMARDs (Methotrexate, Leflunomide, Salazopyrine, Plaquenil), the dose must have been stable for 3 months.
- If corticosteroids are co-prescribed, the dose should be ≤ 10 mg/d and stable for 3 months.
Key exclusion criteria (6 listed)
- Other associated targeted disease-modifying therapy
- Sjögren's syndrome or other associated inflammatory rheumatism
- Fibromyalgia or other pathology having an impact on the assessment of disease activity
- Any active haematological disease affecting lymphocytes (chronic lymphocytic leukaemia, Hodgkin's and non-Hodgkin's lymphomas, lymphoplasmacytic lymphoma, T lymphoma).
- Opposition to data processing
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
Observed Disease Activity Score(DAS) 28-CRP
Time frame: 6 months after a second low-dose cycle
DAS28-CRP measured by the clinician 6 months after the second cycle of rituximab
Calculated DAS28-CRP
Time frame: 6 months after a second low-dose cycle
DAS28-CRP calculated 6 months after the second cycle of rituximab by a PK-PD model, taking into account gender, body surface area in m2, IgG concentration, rituximab concentration and CD4+ T-cell count
5 secondary outcomes
Prevalence observed DAS28-CRP
Time frame: 3 months and 6 months of the first and second cycle of low-dose rituximab
Description of events
Time frame: From enrolment to 12 months
prevalence calculated DAS28-CRP
Time frame: 6 months of the second cycle of low-dose rituximab
CD4 T cell count
Time frame: 6 months of a second cycle of low dose rituximab.
immunoglobulin G level
Time frame: 6 months of a second cycle of low dose rituximab.
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 30 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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 Rheumatoid Arthritis (RA), run by University Hospital, Tours 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 5 inclusion and 6 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 30 Apr 2026. 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 Simon BRUNET (247475917 ext. +33, simon.brunet@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observed Disease Activity Score(DAS) 28-CRP (time frame: 6 months after a second low-dose cycle). The study lists 2 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 30 Apr 2026.