Fixed-dose versus weight-based tocilizumab in rheumatoid arthritis that is calm or in remission
Compares fixed-dose tocilizumab with weight-based dosing in adults whose rheumatoid arthritis is quiet.
Plain-language title generated from the registry record
Registry title: Tdose Binding and Tocilizumab
Key facts
- Where
- Marseille and Nice, FranceSee the 2 sites
- Phase
- Phase 4
Where in France
- Hôpital Saint JosephMarseille, FranceNot yet recruiting
- Centre Hospitalier Universitaire de NiceNice, FranceNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Hospitalier Universitaire de Nice
- Trial code
- NCT07582185EU 2025-522319-41-00
- Record updated
- 12 May 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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: 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; Active neoplasia.