CHU de Nice
Nice, France, 06000
Location contact
Christian ROUX, Professor
CONTACT
Damien ROCHE, Doctor
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07582185
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 4
Nice, France, 06000
Christian ROUX, Professor
CONTACT
Damien ROCHE, Doctor
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TOCILIZUMAB administered at standardized, fixed-interval doses versus weight-based dosing
standart administration; weight-based dosing
Time frame: month 3
DAS28 (0 to 28)
Time frame: month 3
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.
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire de Nice
Other
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.
Acronym: TCZ
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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