To evaluate the feasibility of the study after 20 weeks of follow-up, which includes the evaluation of the dose-reduction algorithm in tocilizumab-treated patients with RA.
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
A wide range of serum trough concentrations is observed in tocilizumab-treated
rheumatoid arthritis (RA) patients, while 1 mg/L tocilizumab is sufficient to
block systemic interleukin 6 receptor. Substantial proportion of patients have
higher serum tocilizumab concentrations and are likely to be overexposed. We
expect that patients can at least reduce the dose aiming for a concentration of
5 mg/L without reducing efficacy.
Study objective
To evaluate the feasibility of the study after 20 weeks of follow-up, which
includes the evaluation of the dose-reduction algorithm in tocilizumab-treated
patients with RA.
Study design
Double-blind randomised controlled pilot study with a follow up of 20 weeks.
Intervention
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 the standard care tocilizumab
dose. In the intervention group, the precise dose-reduction is calculated per
patient in order to achieve a tocilizumab concentration of 5 mg/L (range 4-6
mg/L).
Study burden and risks
Dose-reduction will lead to lower drug costs and possibly to reduce the risk of
adverse events. Since we lower the tocilizumab concentration in a proportion of
the patients, risk of a exacerbation of the disease exists. In this case,
patients will receive their original dose. Previous studies showed that
disease activity is controlled adequately after returning to the standard dose.
However, our algorithm is designed to reach concentrations of 5 mg/L (range 4-6
mg/L) and studies showed that 1 mg/L of tocilizumab is sufficient to maintain
clinical effect. The expected burden of this study is low, since study visits
are planned at the time of infusion and therefore do not take extra time. The
additional burden consists of an extra blood sample taken every visit and the
fingerprick that is performed once at home.
Dr. Jan van Breemenstraat 2
Amsterdam 1056 AB
NL
Dr. Jan van Breemenstraat 2
Amsterdam 1056 AB
NL
Listed location countries
Age
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
Scheduled surgery in the next 20 weeks or other preplanned reasons for treatment discontinuation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63658.048.17 |