Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
122
Countries
1
Sites
2
rheumatoid arthritis
The non-inferiority of TOCILIZUMAB in dose-banding will be evaluated through the study of the changes in the DAS28 activity score. The change in this activity score between M0 and M3 will be calculated
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Nice
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Decision date (initial)
- 2026-03-24
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
The non-inferiority of TOCILIZUMAB in dose-banding will be evaluated through the study of the changes in the DAS28 activity score. The change in this activity score between M0 and M3 will be calculated
Secondary objectives 3
- Assess the economic benefit of dose-banding on the production of bags within pharmaceutical technology (cost of preparing the bags)
- Compare the pharmaceutical release time between the two groups
- Compare the rate of non-reassignment of the bags between the two groups
Conditions and MedDRA coding
rheumatoid arthritis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | LLT | 10003268 | Arthritis rheumatoid | 10028395 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Age > 18 years
- Diagnosis of rheumatoid arthritis according to ACR/EULAR criteria
- Rheumatoid arthritis with low disease activity or remission according to DAS28 ...
- Patient to receive a TOCILIZUMAB infusion at 8 mg/kg
- Patient failing treatment with cDMARDs or bDMARDs
- Allowed concomitant treatment(s) for rheumatism: stable doses for at least 3 months of cDMARDs, NSAIDs, analgesics, or corticosteroids (< 10 mg/day of prednisone equivalent)
- Signing of the informed consent
- Affiliation to a social security scheme
Exclusion criteria 9
- Active neoplasm
- 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
- Ongoing pregnancy. A blood pregnancy test will be performed for women of childbearing age. The results will be communicated to the patient by a doctor of her choice.
- Active hepatitis B
- Untreated latent tuberculosis
- Severe or active infection (except for COVID-19)
- Vulnerable individuals: minors, adults under guardianship or curatorship
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The non-inferiority of TOCILIZUMAB in dose-banding will be evaluated through the study of the changes in the DAS28 activity score. The change in this activity score between M0 and M3 will be calculated:
Secondary endpoints 3
- The cost of preparing the bags is estimated based on the preparation time, corresponding to the sum of the sterilization, production, and bag release times over the 3 months of the study in each of the 2 groups. The total cost over the 3 months of the study will then be divided by the number of infusions to be administered in order to obtain a cost per infusion in each group.
- 2. The pharmaceutical release time will be defined as the time in minutes between medical approval, determined by the production of the prescription, and approval for transport to the department. ...
- The non-reallocation rate will be defined by the number of unused bags over the number of reallocated bags.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
RoActemra 20 mg/mL concentrate for solution for infusion
PRD2154620 · Product
- Active substance
- Tocilizumab
- Substance synonyms
- RO4877533, BIIB800, ATLIZUMAB, TOCILIZUMABUM
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 840 mg milligram(s)
- Max total dose
- 2520 mg milligram(s)
- Max treatment duration
- 90 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AC07 — -
- Marketing authorisation
- EU/1/08/492/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
RoActemra 20 mg/mL concentrate for solution for infusion
PRD2154624 · Product
- Active substance
- Tocilizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 840 mg milligram(s)
- Max total dose
- 2520 mg milligram(s)
- Max treatment duration
- 90 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AC07 — -
- Marketing authorisation
- EU/1/08/492/005
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Nice
- Sponsor organisation
- Centre Hospitalier Universitaire De Nice
- Address
- 4 Avenue Reine Victoria
- City
- Nice
- Postcode
- 06000
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Nice
- Contact name
- Pr ROUX Christian
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nice
- Contact name
- Pr Christian ROUX
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 122 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 - Protocole 2025-522319-41-00 | 0.2 |
| Recruitment arrangements (for publication) | K2_Recruitmentarrangement | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF partenaire enceinte_TCZ | 0.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_TCZ | 0.2 |
| Summary of Product Characteristics (SmPC) (for publication) | G2 roactemra | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_roactemra | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis2025-522319-41-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-02 | France | Acceptable 2026-03-19
|
2026-03-24 |