Rheumatoid ArthritisPhase 4TODORANCT03895879
Use of Tocilizumab Drug Levels to Optimize Treatment in RA
A Phase 4 study testing Tocilizumab in people with Rheumatoid Arthritis, run by Reade Rheumatology Research Institute at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Tocilizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2020to Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Reade Rheumatology Research Institute
Amsterdam, 1056 AB
Femke Hooijberg, MD, 0031 20 2421633, f.hooijberg@reade.nl
About this study
Official title: Concentration-guided Dose Reduction Versus Standard Dosing in Tocilizumab-treated Rheumatoid Arthritis Patients: a Randomised, Multicenter, Non-inferiority Trial (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.
Read the detailed description
Tocilizumab is a humanized monoclonal antibody targeting the IL-6 receptor (IL-6R). It has proven to be effective in reducing inflammation and symptoms in rheumatoid arthritis (RA). The registered standard dose of tocilizumab subcutaneously (sc) is 162 mg weekly for every patient. All patients diagnosed with RA and treated with tocilizumab sc receive the same dose, so treatment with expensive biologicals is currently based on a 'one size fits all' approach. Because of the large inter-individual variability in the pharmacokinetics of tocilizumab this standard dose results in a wide range of serum concentrations. In the search to optimize the dose for individual patients it was demonstrated that serum levels of 1 mg/L of tocilizumab are adequate to block the IL-6 receptor systemically, as indicated by a reduction in CRP levels in patients with these low trough concentrations. Therefore, a substantial proportion of patients is likely to be overexposed to tocilizumab. This overtreatment is a waste of health care resources and might be associated with an increased risk of adverse events, mainly infections.
We believe that overexposure can be reduced effectively by making use of the drug concentrations found in the serum of individual patients. Our hypothesis is therefore that reducing the dose in the setting of therapeutic drug monitoring (TDM) does not affect clinical disease activity and safety, while it will reduce costs.
Based on previous studies we believe that a concentration around 5 mg/L is sufficient to reach the maximal treatment effect. Therefore tapering strategy was developed aiming for serum concentrations around 5 mg/L. Monte Carlo modelling was performed to determine the cut-off concentration for interval prolongation to be used in this study. Simulations were performed and it was found that patients with trough concentrations above 15 mg/L can safely prolong their dosing interval, as this will result in levels around 5 mg/L in the majority of patients.
This study is a 52 weeks randomised, multicenter, non-inferiority trial in rheumatoid arthritis patients treated with subcutaneous tocilizumab 162 mg weekly for at least the previous 6 months. After informed consent is obtained during the baseline visit, blood will be drawn to measure drug trough concentrations. Patients with a tocilizumab concentration above 15 mg/L will be randomly assigned to dose reduction by increasing their dosing-interval from once every week to once every two weeks, or to continuation of their tocilizumab dose (standard dose). After randomization, patients are followed for a period of 52 weeks. Data regarding disease status and functioning will be collected during the baseline visit, and 12, 28, 40, and 52 weeks thereafter. Blood will also be drawn from the patients during these visits. All patients with concentrations below 15 mg/L during the first study visit will not be randomized and all continue standard treatment. Only one follow-up visit, after 52 weeks, will be performed in this group of patients.
Patients can also choose to participate in a sub-study where the finger prick developed by Sanquin (Amsterdam) will be validated to measure tocilizumab drug levels. This part of the study will comprise performing three finger pricks. These finger pricks will be performed during the visit at week 12 with the help of a nurse, and at home during the two weeks after this visit.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Tocilizumab
- Keywords
- Rheumatoid Arthritis, Tocilizumab, Therapeutic Drug Monitoring, Drug level, Dose reduction
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
Tocilizumab sc (162 mg) once every 2 weeks
TocilizumabDrug
Tocilizumab sc (162 mg) once every week
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Tocilizumab administered every 2 weeks Receives: Drug: Tocilizumab |
| Control | Active comparator | Tocilizumab administered every week Receives: Drug: Tocilizumab |
| Standard dose (screening < 15 mg/L) | Active comparator | Tocilizumab administered every week Receives: Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
DAS28-ESR
The difference in mean time weighted DAS28 after 28 weeks between patients undergoing concentration-guided dose reduction or standard dosing.
Measured: 28 weeks
Secondary outcomes (9)
DAS28-ESR
The difference in mean time weighted DAS28 after 52 weeks between patients undergoing concentration-guided dose reduction or standard dosing.
Measured: 52 weeks
Clinical Disease Activity Index (CDAI)
The difference in CDAI-score after 28 and 52 weeks between the patients undergoing concentration-guided dose reduction or standard dosing.
Measured: 28 and 52 weeks
Simple Disease Activity Index (SDAI)
The difference in SDAI-score after 28 and 52 weeks between the patients undergoing concentration-guided dose reduction or standard dosing.
Measured: 28 and 52 weeks
Health Assessment Questionnaire (HAQ)
The difference in HAQ-score after 28 and 52 weeks between the patients undergoing concentration-guided dose reduction or standard dosing.
Measured: 28 and 52 weeks
Direct medical costs of TDM
The difference in direct medical costs of TDM compared to the standard treatment regimen.
Measured: 52 weeks
Number of flares
The difference in number of flares at 28 and 52 weeks between patients undergoing concentration-guided dose reduction or standard dosing.
Measured: 28 and 52 weeks
Number and severity of adverse events
The difference in number and severity of adverse events at 28 and 52 weeks between patients undergoing concentration-guided dose reduction or standard dosing.
Measured: 28 and 52 weeks
Drug level
The difference in drug levels in the intervention group between week 0 and 52.
Measured: 52 weeks
Patient perspective towards therapeutic drug monitoring
A questionnaire will be used to evaluate the perspective of patients towards therapeutic drug monitoring.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start1 Mar 2020
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Patients with tocilizumab trough concentrations above 15 mg/L will be randomly assigned to dose reduction by increasing their dosing interval from once every week to once every two weeks, or to continuation of the standard dose. All patients with concentrations below 15 mg/L during the first study visit will not be randomized and all continue standard treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reade Rheumatology Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Gertjan Wolbink, MD, PhD, Principal investigator, Reade Rheumatology Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895879
- Sponsor's protocol ID
- TODORA
- Other IDs
- 2018-004605-57, NL68462.029.19, 2018
- Acronym
- TODORA
- Status last verified
- Apr 2024
- First submitted
- 26 Mar 2019
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To avoid duplication of research, the data gathered in this study will be shared once all desirable data analysis have been performed and the results are published.
Publications
Kneepkens EL, van den Oever I, Plasencia CH, Pascual-Salcedo D, de Vries A, Hart M, Nurmohamed MT, Balsa A, Rispens T, Wolbink G. Serum tocilizumab trough concentration can be used to monitor systemic IL-6 receptor blockade in patients with rheumatoid arthritis: a prospective observational cohort study. Scand J Rheumatol. 2017 Mar;46(2):87-94. doi: 10.1080/03009742.2016.1183039. Epub 2016 Jul 20.
PubMed 27440258l'Ami MJ, Krieckaert CL, Nurmohamed MT, van Vollenhoven RF, Rispens T, Boers M, Wolbink GJ. Successful reduction of overexposure in patients with rheumatoid arthritis with high serum adalimumab concentrations: an open-label, non-inferiority, randomised clinical trial. Ann Rheum Dis. 2018 Apr;77(4):484-487. doi: 10.1136/annrheumdis-2017-211781. Epub 2017 Sep 22.
PubMed 28939629Frey N, Grange S, Woodworth T. Population pharmacokinetic analysis of tocilizumab in patients with rheumatoid arthritis. J Clin Pharmacol. 2010 Jul;50(7):754-66. doi: 10.1177/0091270009350623. Epub 2010 Jan 23.
PubMed 20097931Bastida C, Ruiz-Esquide V, Pascal M, de Vries Schultink AHM, Yague J, Sanmarti R, Huitema ADR, Soy D. Fixed dosing of intravenous tocilizumab in rheumatoid arthritis. Results from a population pharmacokinetic analysis. Br J Clin Pharmacol. 2018 Apr;84(4):716-725. doi: 10.1111/bcp.13500. Epub 2018 Feb 7.
PubMed 29314183
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concentration-guided Dose Reduction Versus Standard Dosing in Tocilizumab-treated Rheumatoid Arthritis Patients: a Randomised, Multicenter, Non-inferiority Trial (TODORA)
- ClinicalTrials.gov ID
- NCT03895879
- Acronym / sponsor ID
- TODORA / TODORA
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Tocilizumab, Therapeutic Drug Monitoring, Drug level, Dose reduction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Reade Rheumatology Research InstituteUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 29 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Tocilizumab is a humanized monoclonal antibody targeting the IL-6 receptor (IL-6R). It has proven to be effective in reducing inflammation and symptoms in rheumatoid arthritis (RA). The registered standard dose of tocilizumab subcutaneously (sc) is 162 mg weekly for every patient. All patients diagnosed with RA and treated with tocilizumab sc receive the same dose, so treatment with expensive biologicals is currently based on a 'one size fits all' approach. Because of the large inter-individual variability in the pharmacokinetics of tocilizumab this standard dose results in a wide range of serum concentrations. In the search to optimize the dose for individual patients it was demonstrated that serum levels of 1 mg/L of tocilizumab are adequate to block the IL-6 receptor systemically, as indicated by a reduction in CRP levels in patients with these low trough concentrations. Therefore, a substantial proportion of patients is likely to be overexposed to tocilizumab. This overtreatment is a waste of health care resources and might be associated with an increased risk of adverse events, mainly infections.
We believe that overexposure can be reduced effectively by making use of the drug concentrations found in the serum of individual patients. Our hypothesis is therefore that reducing the dose in the setting of therapeutic drug monitoring (TDM) does not affect clinical disease activity and safety, while it will reduce costs.
Based on previous studies we believe that a concentration around 5 mg/L is sufficient to reach the maximal treatment effect. Therefore tapering strategy was developed aiming for serum concentrations around 5 mg/L. Monte Carlo modelling was performed to determine the cut-off concentration for interval prolongation to be used in this study. Simulations were performed and it was found that patients with trough concentrations above 15 mg/L can safely prolong their dosing interval, as this will result in levels around 5 mg/L in the majority of patients.
This study is a 52 weeks randomised, multicenter, non-inferiority trial in rheumatoid arthritis patients treated with subcutaneous tocilizumab 162 mg weekly for at least the previous 6 months. After informed consent is obtained during the baseline visit, blood will be drawn to measure drug trough concentrations. Patients with a tocilizumab concentration above 15 mg/L will be randomly assigned to dose reduction by increasing their dosing-interval from once every week to once every two weeks, or to continuation of their tocilizumab dose (standard dose). After randomization, patients are followed for a period of 52 weeks. Data regarding disease status and functioning will be collected during the baseline visit, and 12, 28, 40, and 52 weeks thereafter. Blood will also be drawn from the patients during these visits. All patients with concentrations below 15 mg/L during the first study visit will not be randomized and all continue standard treatment. Only one follow-up visit, after 52 weeks, will be performed in this group of patients.
Patients can also choose to participate in a sub-study where the finger prick developed by Sanquin (Amsterdam) will be validated to measure tocilizumab drug levels. This part of the study will comprise performing three finger pricks. These finger pricks will be performed during the visit at week 12 with the help of a nurse, and at home during the two weeks after this visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Patients with tocilizumab trough concentrations above 15 mg/L will be randomly assigned to dose reduction by increasing their dosing interval from once every week to once every two weeks, or to continuation of the standard dose. All patients with concentrations below 15 mg/L during the first study visit will not be randomized and all continue standard treatment.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: TocilizumabTocilizumab administered every 2 weeks |
| Control | Active comparator | Drug: TocilizumabTocilizumab administered every week |
| Standard dose (screening < 15 mg/L) | Active comparator | Drug: TocilizumabTocilizumab administered every week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TocilizumabTocilizumab sc (162 mg) once every 2 weeks | Drug | Intervention |
| TocilizumabTocilizumab sc (162 mg) once every week | Drug | Control, Standard dose (screening < 15 mg/L) |
Primary outcome
DAS28-ESR
Time frame: 28 weeks
The difference in mean time weighted DAS28 after 28 weeks between patients undergoing concentration-guided dose reduction or standard dosing.
9 secondary outcomes
DAS28-ESR
Time frame: 52 weeks
Clinical Disease Activity Index (CDAI)
Time frame: 28 and 52 weeks
Simple Disease Activity Index (SDAI)
Time frame: 28 and 52 weeks
Health Assessment Questionnaire (HAQ)
Time frame: 28 and 52 weeks
Direct medical costs of TDM
Time frame: 52 weeks
Number of flares
Time frame: 28 and 52 weeks
Number and severity of adverse events
Time frame: 28 and 52 weeks
Drug level
Time frame: 52 weeks
Patient perspective towards therapeutic drug monitoring
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Background: PubMed 27440258Kneepkens EL, van den Oever I, Plasencia CH, Pascual-Salcedo D, de Vries A, Hart M, Nurmohamed MT, Balsa A, Rispens T, Wolbink G. Serum tocilizumab trough concentration can be used to monitor systemic IL-6 receptor blockade in patients with rheumatoid arthritis: a prospective observational cohort study. Scand J Rheumatol. 2017 Mar;46(2):87-94. doi: 10.1080/03009742.2016.1183039. Epub 2016 Jul 20.
- Background: PubMed 28939629l'Ami MJ, Krieckaert CL, Nurmohamed MT, van Vollenhoven RF, Rispens T, Boers M, Wolbink GJ. Successful reduction of overexposure in patients with rheumatoid arthritis with high serum adalimumab concentrations: an open-label, non-inferiority, randomised clinical trial. Ann Rheum Dis. 2018 Apr;77(4):484-487. doi: 10.1136/annrheumdis-2017-211781. Epub 2017 Sep 22.
- Background: PubMed 20097931Frey N, Grange S, Woodworth T. Population pharmacokinetic analysis of tocilizumab in patients with rheumatoid arthritis. J Clin Pharmacol. 2010 Jul;50(7):754-66. doi: 10.1177/0091270009350623. Epub 2010 Jan 23.
- Background: PubMed 29314183Bastida C, Ruiz-Esquide V, Pascal M, de Vries Schultink AHM, Yague J, Sanmarti R, Huitema ADR, Soy D. Fixed dosing of intravenous tocilizumab in rheumatoid arthritis. Results from a population pharmacokinetic analysis. Br J Clin Pharmacol. 2018 Apr;84(4):716-725. doi: 10.1111/bcp.13500. Epub 2018 Feb 7.
- Individual participant dataSharing planned: Yes. To avoid duplication of research, the data gathered in this study will be shared once all desirable data analysis have been performed and the results are published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gertjan Wolbink, MD, PhD principal investigator
Reade Rheumatology Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tocilizumab in people with Rheumatoid Arthritis, run by Reade Rheumatology Research Institute at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Femke Hooijberg, MD (0031 20 2421633, f.hooijberg@reade.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DAS28-ESR (time frame: 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03895879, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.