Tdose Binding and Tocilizumab
- Sponsor
- Centre Hospitalier Universitaire de Nice
- Study ID
- NCT07582185
- Phase
- PHASE4
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Experimental: dose binding arm — DRUGTOCILIZUMAB administered at standardized, fixed-interval doses versus weight-based dosing
- Active Comparator: traditionnal arm: Weight-based dosing — DRUGstandart administration; weight-based dosing
Study Details
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.
Key Dates
- First listed
- May 12, 2026
- Start date
- Jun 1, 2026
- Status verified
- May 2026
- Primary completion
- Sep 30, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 122 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: dose binding armdose binding arm for tocilizumab
- Active Comparator: traditionnal armdose weight for tocilizumab
Primary Outcome Measure
disease activity [ Time Frame: month 3 ]
Central Contacts
- Christian ROUX, Professor0492035477
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