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

Who is this study for? Patients with rheumatoid arthritis
What treatments are being studied? Tocilizumab
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Reade Rheumatology Research Institute
RECRUITING
Amsterdam
Contact Information
Primary
Femke Hooijberg, MD
f.hooijberg@reade.nl
0031 20 2421633
Backup
Sadaf Atiqi, MD
s.atiqi@reade.nl
0031 20 2421641
Time Frame
Start Date: 2020-03-01
Estimated Completion Date: 2024-12
Participants
Target number of participants: 98
Treatments
Experimental: Intervention
Tocilizumab administered every 2 weeks
Active_comparator: Control
Tocilizumab administered every week
Active_comparator: Standard dose (screening < 15 mg/L)
Tocilizumab administered every week
Related Therapeutic Areas
Sponsors
Leads: Reade Rheumatology Research Institute
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development

This content was sourced from clinicaltrials.gov

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