Tdose Binding and Tocilizumab
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental: dose binding arm, Active Comparator: traditionnal arm: Weight-based dosing.
- Who it may be relevant to
- Registry conditions: Rheumatoid Arthritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- Drug Experimental: dose binding arm
TOCILIZUMAB administered at standardized, fixed-interval doses versus weight-based dosing - Drug Active Comparator: traditionnal arm: Weight-based dosing
standart administration; weight-based dosing
Primary outcome measures
- disease activity [Time frame: month 3]
Secondary outcome measures (1)
- cost [Time frame: month 3]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- CHU de Nice — Nice
Identifiers
NCT: NCT07582185 · 24-AOI-MED-01 · 2025-522319-41-00