Concentration-guided Dose Reduction Versus Standard Dosing in Tocilizumab-treated Rheumatoid Arthritis Patients: a Randomised, Multicenter, Non-inferiority Trial (TODORA)

TODORA

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.

2020-03-01

2024-12-01

2024-12-01

Recruiting

Early phase I

98

Inclusion Criteria: * Rheumatoid arthritis according to the American College of Rheumatology (ACR) 1987 or 2010 criteria; * Current use of subcutaneous tocilizumab 162 mg weekly, for at least the previous 6 months; * The treating rheumatologist is convinced of the benefit of tocilizumab continuation; * Written informed consent. Exclusion Criteria: * A scheduled surgery in the next 52 weeks or other pre-planned reasons for treatment discontinuation; * Changes in the treatment with glucocorticoids and DMARDs such as methotrexate in the past three months.

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2024-04-18