rheuma rheumatoid arthritis
Conditions
Interventions
Patients with a concentration below 5 mg/L will continue the dose. Those
patients with a tocilizumab concentration above 5 mg/L are randomly assigned
(2:1) to dose reduction or to continuation of th
Sponsors
Amsterdam Rheumatology and immunology Center | Reade
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: RA according to the ACR 1987 or 2010 criteria; Current use of tocilizumab iv, with a consistent interval of 4 weeks for at least 24 weeks.
Exclusion criteria
Exclusion criteria: Scheduled surgery in the next 20 weeks or other preplanned reasons for treatment discontinuation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study outcome is the feasibility of the study logistics This will be evaluated according to the following endpoints: - Percentage of patients completing 20-weeks follow-up. We accept a drop out of 10%. - We only accept a few protocol deviations, when there are more than 3 protocol deviations, the protocol should be adjusted according to this deviations. - The opinion of approached and participating patients about the study protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study outcome is the feasibility of the dose reduction algorithme. The algorithm is feasible if 80% of the patients achieve serum concentration in the range of 4-6 mg/L and none of the patients has a drug concentration below 1 mg/L. If between 50% and 80% of the patients achieve the targeted range, the algorithm must be adjusted before implementation in further studies. When less than 50% of the patients achieve the targeted drug concentration range, a new algorithm must be designed. | — |
Countries
Netherlands
Outcome results
None listed