Non-inferiority study of TOCILIZUMAB in dose-banding versus dose-weight in rheumatoid arthritis with low activity or clinical remission

Conditions

rheumatoid arthritis

Brief summary

The non-inferiority of TOCILIZUMAB in dose-banding will be evaluated through the study of the changes in the DAS28 activity score. The change in this activity score between M0 and M3 will be calculated:

Detailed description

The cost of preparing the bags is estimated based on the preparation time, corresponding to the sum of the sterilization, production, and bag release times over the 3 months of the study in each of the 2 groups. The total cost over the 3 months of the study will then be divided by the number of infusions to be administered in order to obtain a cost per infusion in each group., 2. The pharmaceutical release time will be defined as the time in minutes between medical approval, determined by the production of the prescription, and approval for transport to the department. ..., The non-reallocation rate will be defined by the number of unused bags over the number of reallocated bags.

Related papers

No related papers found yet.

Interventions

DRUGRoActemra 20 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The non-inferiority of TOCILIZUMAB in dose-banding will be evaluated through the study of the changes in the DAS28 activity score. The change in this activity score between M0 and M3 will be calculated:	—

Secondary

Measure	Time frame
The cost of preparing the bags is estimated based on the preparation time, corresponding to the sum of the sterilization, production, and bag release times over the 3 months of the study in each of the 2 groups. The total cost over the 3 months of the study will then be divided by the number of infusions to be administered in order to obtain a cost per infusion in each group., 2. The pharmaceutical release time will be defined as the time in minutes between medical approval, determined by the production of the prescription, and approval for transport to the department. ..., The non-reallocation rate will be defined by the number of unused bags over the number of reallocated bags.	—

Measure

Time frame

The cost of preparing the bags is estimated based on the preparation time, corresponding to the sum of the sterilization, production, and bag release times over the 3 months of the study in each of the 2 groups. The total cost over the 3 months of the study will then be divided by the number of infusions to be administered in order to obtain a cost per infusion in each group., 2. The pharmaceutical release time will be defined as the time in minutes between medical approval, determined by the production of the prescription, and approval for transport to the department. ..., The non-reallocation rate will be defined by the number of unused bags over the number of reallocated bags.

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Outcome results

None listed