A Phase 4 interventional study of Experimental: dose binding arm and Active Comparator: traditionnal arm: Weight-based dosing in Rheumatoid Arthritis, sponsored by Centre Hospitalier Universitaire de Nice. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Centre Hospitalier Universitaire de Nice · Phase 4, Interventional, and Treatment
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.
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.
2,888 studies on the registry are indexed under Arthritis, Rheumatoid; 390 are open to participants now.
This study's planned enrollment of 122 is above the median of 94 across 1,984 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.
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Exclusion Criteria:
dose binding arm for tocilizumab
Drug: Experimental: dose binding arm
dose weight for tocilizumab
Drug: Active Comparator: traditionnal arm: Weight-based dosing
TOCILIZUMAB administered at standardized, fixed-interval doses versus weight-based dosing
standart administration; weight-based dosing
disease activity
DAS28 (0 to 28)
Time frame: month 3
cost
The cost of preparing the bags is estimated based on the preparation time, which is the sum of the time spent on sterilization, production, and bag distribution over the 3-month study period in each of the two groups. The total cost over the 3-month study period will then be divided by the number of infusions to be administered to calculate the cost per infusion in each group.
Time frame: month 3
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nice