Optimizing Tocilizumab Treatment for Rheumatoid Arthritis
Concentration-guided Dose Reduction Versus Standard Dosing in Tocilizumab-treated Rheumatoid Arthritis Patients: a Randomised, Multicenter, Non-inferiority Trial (TODORA)
This study is testing if people with rheumatoid arthritis can safely take their tocilizumab medication every two weeks instead of weekly without it affecting how well it works.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Reade Rheumatology Research Institute Academic / other |
| Drugs / interventions | tocilizumab, methotrexate |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT03895879 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether patients with rheumatoid arthritis (RA) who have high serum levels of tocilizumab can safely extend their dosing interval from weekly to every two weeks without losing clinical effectiveness. The study will involve a 52-week multicenter, randomized controlled design, where participants will be assigned to either continue their standard weekly dose or switch to the extended dosing schedule. The primary goal is to assess the impact on disease activity while potentially reducing medication costs and minimizing the risk of adverse effects associated with overtreatment.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with rheumatoid arthritis who have been on a stable dose of subcutaneous tocilizumab for at least six months.
Not a fit: Patients who are scheduled for surgery or have had recent changes in their glucocorticoid or DMARD treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized treatment plans for RA patients, reducing unnecessary medication costs and side effects.
How similar studies have performed: Previous studies have indicated that therapeutic drug monitoring can effectively optimize treatment regimens, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Amsterdam
- Reade Rheumatology Research Institute — Amsterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Gertjan Wolbink, MD, PhD — Reade Rheumatology Research Institute
- Study coordinator: Femke Hooijberg, MD
- Email: f.hooijberg@reade.nl
- Phone: 0031 20 2421633
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.