Rheumatoid ArthritisPhase 4TCZNCT07582185
Tdose Binding and Tocilizumab
A Phase 4 study testing Experimental: dose binding arm and Active Comparator: traditionnal arm: Weight-based dosing in people with Rheumatoid Arthritis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The investigators aim to evaluate the non-inferiority of administering tocilizumab at a fixed dose versus a weight-based dose in patients with rheumatoid arthritis in remission or with low clinical activity, after 3 months of treatment, as part of a two-center randomized trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Experimental: dose binding arm and Active Comparator: traditionnal arm: Weight-based dosing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2026to 31 Dec 2026
- Phase
- Phase 4
- 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
Who may be able to join
- Diagnosis of rheumatoid arthritis according to ACR/EULAR criteria
- Rheumatoid Arthritis in low activity or remission according to DAS28
- Patient to receive a TOCILIZUMAB infusion 8mg/kg
- Patient with failure of treatment with cDMARDs or bDMARDs
- Concomitant treatment(s) for rheumatism allowed: stable doses for at least 3 months of cDMARDs, NSAIDs, analgesics, or corticosteroid therapy (< 10 mg/day of prednisone equivalent)
Who cannot join
- Active neoplasia
- Treatment with TOCILIZUMAB for an indication other than rheumatoid arthritis
- Treatment with TOCILIZUMAB at a dosage other than 8 mg/kg
- Diverticulitis or history of digestive perforation
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
CHU de Nice
Nice, France, 06000
Christian ROUX, Professor, 0492034702, roux.c2@chu-nice.fr
Damien ROCHE, Doctor
About this study
Official title: Non-inferiority Study of TOCILIZUMAB Administered at Standardized, Fixed-interval Doses Versus Weight-based Dosing in Patients With Low-activity or Clinically Remitted Rheumatoid Arthritis.
The investigators aim to evaluate the non-inferiority of administering tocilizumab at a fixed dose versus a weight-based dose in patients with rheumatoid arthritis in remission or with low clinical activity, after 3 months of treatment, as part of a two-center randomized trial.
Read the detailed description
The investigators aim to evaluate the non-inferiority of dose-banding versus weight-based dosing of tocilizumab in patients with rheumatoid arthritis in remission or with low clinical activity, at 3 months of treatment. The secondary objectives are: To evaluate the economic benefit of dose-banding on the production of bags in the pharmacy (cost of preparing the bags), To compare the time to pharmaceutical release between the two groups, To compare the rate of bag reallocation between the two groups. This is a multicenter, prospective, randomized study evaluating the non-inferiority of administering standard doses of TOCILIZUMAB versus weight-based doses in patients with rheumatoid arthritis in remission or with low clinical activity. The patient and the clinical evaluator will be blinded. The pharmacy team performing the preparation will be open-label.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Experimental: dose binding arm, Active Comparator: traditionnal arm: Weight-based dosing
- Keywords
- remission, low disease activity, dose binding, health economics, Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: dose binding armDrug
TOCILIZUMAB administered at standardized, fixed-interval doses versus weight-based dosing
Active Comparator: traditionnal arm: Weight-based dosingDrug
standart administration; weight-based dosing
| Study group | Role | What they receive |
|---|---|---|
| dose binding arm | Experimental | dose binding arm for tocilizumab Receives: Drug: Experimental: dose binding arm |
| traditionnal arm | Active comparator | dose weight for tocilizumab Receives: Drug: Active Comparator: traditionnal arm: Weight-based dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease activity
DAS28 (0 to 28)
Measured: month 3
Secondary outcomes (1)
cost
The cost of preparing the bags is estimated based on the preparation time, which is the sum of the time spent on sterilization, production, and bag distribution over the 3-month study period in each of the two groups. The total cost over the 3-month study period will then be divided by the number of infusions to be administered to calculate the cost per infusion in each group.
Measured: month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- bicentric randomized study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian ROUX, Doctor, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582185
- Sponsor's protocol ID
- 24-AOI-MED-01
- Other IDs
- 2025-522319-41-00, 2025
- Acronym
- TCZ
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 12 May 2026
- 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 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Study of TOCILIZUMAB Administered at Standardized, Fixed-interval Doses Versus Weight-based Dosing in Patients With Low-activity or Clinically Remitted Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT07582185
- Acronym / sponsor ID
- TCZ / 24-AOI-MED-01
- Conditions
- Rheumatoid Arthritis
- Keywords
- remission, low disease activity, dose binding, health economics, Rheumatoid Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 May 2026 (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 investigators aim to evaluate the non-inferiority of administering tocilizumab at a fixed dose versus a weight-based dose in patients with rheumatoid arthritis in remission or with low clinical activity, after 3 months of treatment, as part of a two-center randomized trial.
Detailed description
The investigators aim to evaluate the non-inferiority of dose-banding versus weight-based dosing of tocilizumab in patients with rheumatoid arthritis in remission or with low clinical activity, at 3 months of treatment. The secondary objectives are: To evaluate the economic benefit of dose-banding on the production of bags in the pharmacy (cost of preparing the bags), To compare the time to pharmaceutical release between the two groups, To compare the rate of bag reallocation between the two groups. This is a multicenter, prospective, randomized study evaluating the non-inferiority of administering standard doses of TOCILIZUMAB versus weight-based doses in patients with rheumatoid arthritis in remission or with low clinical activity. The patient and the clinical evaluator will be blinded. The pharmacy team performing the preparation will be open-label.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- bicentric randomized study
| Arm | Type | Receives |
|---|---|---|
| dose binding arm | Experimental | Drug: Experimental: dose binding armdose binding arm for tocilizumab |
| traditionnal arm | Active comparator | Drug: Active Comparator: traditionnal arm: Weight-based dosingdose weight for tocilizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of rheumatoid arthritis according to ACR/EULAR criteria
- Rheumatoid Arthritis in low activity or remission according to DAS28
- Patient to receive a TOCILIZUMAB infusion 8mg/kg
- Patient with failure of treatment with cDMARDs or bDMARDs
- Concomitant treatment(s) for rheumatism allowed: stable doses for at least 3 months of cDMARDs, NSAIDs, analgesics, or corticosteroid therapy (< 10 mg/day of prednisone equivalent)
Key exclusion criteria (4 listed)
- Active neoplasia
- Treatment with TOCILIZUMAB for an indication other than rheumatoid arthritis
- Treatment with TOCILIZUMAB at a dosage other than 8 mg/kg
- Diverticulitis or history of digestive perforation
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 |
|---|---|---|
| Experimental: dose binding armTOCILIZUMAB administered at standardized, fixed-interval doses versus weight-based dosing | Drug | dose binding arm |
| Active Comparator: traditionnal arm: Weight-based dosingstandart administration; weight-based dosing | Drug | traditionnal arm |
Primary outcome
disease activity
Time frame: month 3
DAS28 (0 to 28)
1 secondary outcome
cost
Time frame: month 3
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 12 May 2026.
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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.
Christian ROUX, Doctor principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Experimental: dose binding arm and Active Comparator: traditionnal arm: Weight-based dosing in people with Rheumatoid Arthritis, 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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 12 May 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Christian ROUX, Professor (0492035477, roux.c2@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease activity (time frame: month 3). 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 12 May 2026.