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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 April 2024 |
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Main ID: |
NCT03895879 |
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Date of registration:
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26/03/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Use of Tocilizumab Drug Levels to Optimize Treatment in RA
TODORA |
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Scientific title:
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Concentration-guided Dose Reduction Versus Standard Dosing in Tocilizumab-treated Rheumatoid Arthritis Patients: a Randomised, Multicenter, Non-inferiority Trial (TODORA) |
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Date of first enrolment:
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March 1, 2020 |
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Target sample size:
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98 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03895879 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Gertjan Wolbink, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Reade Rheumatology Research Institute |
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Name:
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Femke Hooijberg, MD |
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Address:
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Telephone:
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0031 20 2421633 |
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Email:
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f.hooijberg@reade.nl |
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Affiliation:
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Name:
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Femke Hooijberg, MD |
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Address:
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Telephone:
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0031 20 2421633 |
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Email:
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f.hooijberg@reade.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Tocilizumab
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Primary Outcome(s)
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DAS28-ESR
[Time Frame: 28 weeks]
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Secondary Outcome(s)
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Number and severity of adverse events
[Time Frame: 28 and 52 weeks]
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Clinical Disease Activity Index (CDAI)
[Time Frame: 28 and 52 weeks]
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Patient perspective towards therapeutic drug monitoring
[Time Frame: 52 weeks]
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DAS28-ESR
[Time Frame: 52 weeks]
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Direct medical costs of TDM
[Time Frame: 52 weeks]
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Health Assessment Questionnaire (HAQ)
[Time Frame: 28 and 52 weeks]
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Simple Disease Activity Index (SDAI)
[Time Frame: 28 and 52 weeks]
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Drug level
[Time Frame: 52 weeks]
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Number of flares
[Time Frame: 28 and 52 weeks]
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Secondary ID(s)
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NL68462.029.19
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TODORA
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2018-004605-57
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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