Use of Tocilizumab Drug Levels to Optimize Treatment in RA
Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
Summary
Tocilizumab concentrations above 1 mg/L are likely to be sufficient for normalizing
C-reactive protein (CRP) production in patients with rheumatoid arthritis (RA). In practice,
however, a large variability in the concentrations of tocilizumab is found, and a large
proportion of patients treated with tocilizumab subcutaneously (sc) have concentrations far
above 1 mg/L. These patients can probably lower their doses without losing clinical response.
A 52 weeks non-inferiority, multicenter, randomized controlled study will be performed to
investigate whether patients with RA with serum trough concentrations of tocilizumab higher
than 15 mg/L can increase their dosing interval to every two weeks without losing clinical
response. Patients with relatively high trough concentrations will be randomly assigned to
continuation of the standard dose or to increase dosing interval to every two weeks. The main
objective is to investigate the difference in mean time weighted Disease Activity Score in 28
joints, including erythrocyte sedimentation rate (DAS28-ESR) between the two groups after 28
weeks. It is expected that patients with relatively high trough concentrations can safely
increase their dosing interval without losing response.
Phase:
Phase 4
Details
Lead Sponsor:
Reade Rheumatology Research Institute
Collaborators:
Tel-Aviv Sourasky Medical Center ZonMw: The Netherlands Organisation for Health Research and Development