Clinical trial • Phase IV • Musculoskeletal

Tocilizumab for Rheumatoid arthritis

Phase IV trial of Tocilizumab for Rheumatoid arthritis.

Overview

Trial Therapeutic Area: Musculoskeletal
Trial Disease: Rheumatoid arthritis
Trial Stage: Phase IV
Drug Modality: Monoclonal antibody

Key dates

Initial CTIS Submission Date: 02-12-2025
First CTIS Authorization Date: 24-03-2026

Trial design

Comparator: RoActemra (tocilizumab) 20 mg/mL concentrate for solution for infusion — dose-weight arm receiving tocilizumab 8 mg/kg intravenous infusion (monthly / every 4 weeks). Test arm: RoActemra using dose-banding (standardised fixed dose bands vs weight-based dosing); exact dose bands not specified in source.-controlled Phase IV trial across 2 sites in France.

Comparator: Comparator: RoActemra (tocilizumab) 20 mg/mL concentrate for solution for infusion — dose-weight arm receiving tocilizumab 8 mg/kg intravenous infusion (monthly / every 4 weeks). Test arm: RoActemra using dose-banding (standardised fixed dose bands vs weight-based dosing); exact dose bands not specified in source.
Target Sample Size: 122
Trial Duration For Participant: 90

Eligibility

Recruits 122 Vulnerable individuals are excluded: "Vulnerable individuals: minors, adults under guardianship or curatorship". Informed consent is required (criterion: "Signing of the informed consent"). Minors are excluded; subject information and informed consent form documents are provided (documents: 'L1_SIS and ICF_TCZ' and 'L1_SIS and ICF partenaire enceinte_TCZ')..

Pregnancy Exclusion: 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.
Vulnerable Population: Vulnerable individuals are excluded: "Vulnerable individuals: minors, adults under guardianship or curatorship". Informed consent is required (criterion: "Signing of the informed consent"). Minors are excluded; subject information and informed consent form documents are provided (documents: 'L1_SIS and ICF_TCZ' and 'L1_SIS and ICF partenaire enceinte_TCZ').

Inclusion criteria

{"criterion_text":"- Age > 18 years\n- Diagnosis of rheumatoid arthritis according to ACR/EULAR criteria\n- Rheumatoid arthritis with low disease activity or remission according to DAS28 ...\n- Patient to receive a TOCILIZUMAB infusion at 8 mg/kg\n- Patient failing treatment with cDMARDs or bDMARDs\n- 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)\n- Signing of the informed consent\n- Affiliation to a social security scheme"}

Exclusion criteria

{"criterion_text":"- Active neoplasm\n- Treatment with TOCILIZUMAB for an indication other than rheumatoid arthritis\n- Treatment with TOCILIZUMAB at a dosage other than 8 mg/kg\n- Diverticulitis or history of digestive perforation\n- 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.\n- Active hepatitis B\n- Untreated latent tuberculosis\n- Severe or active infection (except for COVID-19)\n- Vulnerable individuals: minors, adults under guardianship or curatorship"}

Endpoints

Primary endpoints

{"endpoint_text":"- 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:","definition_or_measurement_approach":"Change in DAS28 activity score between M0 and M3 (the change in DAS28 between baseline [M0] and month 3 [M3] will be calculated)"}

Secondary endpoints

{"endpoint_text":"- 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.","definition_or_measurement_approach":"Cost per infusion over 3 months calculated from preparation time (sterilization + production + bag release) divided by number of infusions in each group"}
{"endpoint_text":"- 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. ...","definition_or_measurement_approach":"Pharmaceutical release time measured in minutes from medical approval (prescription production) to approval for transport to the department"}
{"endpoint_text":"- The non-reallocation rate will be defined by the number of unused bags over the number of reallocated bags.","definition_or_measurement_approach":"Non-reallocation rate = number of unused bags / number of reallocated bags"}

Recruitment

Planned Sample Size: 122
Recruitment Window Months: 14
Consent Approach: Informed consent must be signed by the participant (criterion: 'Signing of the informed consent'). Minors are excluded. Subject information and informed consent form documents are provided (documents: 'L1_SIS and ICF_TCZ' and 'L1_SIS and ICF partenaire enceinte_TCZ').

Geography

Total Number Of Sites: 2
Total Number Of Participants: 122

France

Earliest CTIS Part Ii Submission Date: 03-03-2026
Latest Decision Or Authorization Date: 24-03-2026
Processing Time Days: 21
Number Of Sites: 2
Number Of Participants: 122

Sites

Site Name: Hopital Saint Joseph
Department Name: Rhumatology
Principal Investigator Name: Damien Roche
Principal Investigator Email: droche@hopital-saint-joseph.fr
Contact Person Name: Damien Roche
Contact Person Email: droche@hopital-saint-joseph.fr

Site Name: Centre Hospitalier Universitaire De Nice
Department Name: Rhumatology
Principal Investigator Name: Christian Roux
Principal Investigator Email: roux.c@chu-nice.fr
Contact Person Name: Christian Roux
Contact Person Email: roux.c@chu-nice.fr

Sponsor

Primary sponsor

Full Name: Centre Hospitalier Universitaire De Nice
Organisation Type: Hospital/Clinic/Other health care facility
Country Of Registered Address: France

Investigational products

Investigational Product Name: RoActemra 20 mg/mL concentrate for solution for infusion
Active Substance: Tocilizumab
Modality: Monoclonal antibody
Routes Of Administration: Intravenous infusion
Route: Intravenous infusion
Authorisation Status: Authorised (marketing authorisation EU/1/08/492/001)
Starting Dose: 8 mg/kg
Dose Levels: Dose-banding (specific dose bands not specified in source)
Frequency: Every 4 weeks (monthly)
Maximum Dose: 840 mg (max daily); max total amount listed 2520 mg

Investigational Product Name: RoActemra 20 mg/mL concentrate for solution for infusion
Active Substance: Tocilizumab
Modality: Monoclonal antibody
Routes Of Administration: Intravenous infusion
Route: Intravenous infusion
Authorisation Status: Authorised (marketing authorisation EU/1/08/492/005)
Starting Dose: 8 mg/kg
Dose Levels: Weight-based dosing at 8 mg/kg (exact dose-banding not applicable for this arm)
Frequency: Every 4 weeks (monthly)
Maximum Dose: 840 mg (max daily); max total amount listed 2520 mg

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