Concentration-guided dose reduction versus standard dosing in tocilizumab-treated rheumatoid arthritis patients: a randomised, international, multicenter, non-inferiority trial (TODORA)
Recruiting
- Conditions
- Rheumatoid arthritis10003816
- Registration Number
- NL-OMON52409
- Lead Sponsor
- Jan van Breemen Instituut
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 88
Inclusion Criteria
- Rheumatoid arthritis according to the ACR 1897 or 2010 criteria;
- Current use of subcutaneous tocilizumab 162 mg weekly, for at least the last
6 months;
- The treating rheumatologist is convinced of the benefit of tocilizumab
continuation;
- No changes in the treatment with glucocorticoids and DMARDs such as
methotrexate in the past 3 months;
- Written informed consent.
Exclusion Criteria
A scheduled surgery in the next 12 months or other pre-planned reasons for
treatment discontinuation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of the study is to investigate the difference in mean<br /><br>time weighted Disease Activity Score in 28 joints (DAS28-ESR) after 28 weeks in<br /><br>patients with RA with serum trough concentrations higher than 15 mg/L who are<br /><br>randomly assigned to continuation of the standard dose or to increase dosing<br /><br>interval to every two weeks.</p><br>
- Secondary Outcome Measures
Name Time Method