Rheumatoid Arthritis
Conditions
Keywords
remission, low disease activity, dose binding, health economics, Rheumatoid Arthritis
Brief summary
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.
Detailed description
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.
Interventions
DRUGExperimental: dose binding arm
TOCILIZUMAB administered at standardized, fixed-interval doses versus weight-based dosing
DRUGActive Comparator: traditionnal arm: Weight-based dosing
standart administration; weight-based dosing
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
2 dosage of TCZ are given to the patient in the study
Intervention model description
bicentric randomized study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* Active neoplasia * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease activity | month 3 | DAS28 (0 to 28) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cost | 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. |
Countries
France
Contacts
CONTACTChristian ROUX, Professor
PRINCIPAL_INVESTIGATORChristian ROUX, Doctor
Centre Hospitalier Universitaire de Nice
Outcome results
None listed