At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Therapeutic drug monitoring (TDM) of adalimumab (drug)
- How long the study runs
- Study runs about 40 months (dates as stated)
- About the drug or intervention
- Therapeutic drug monitoring (TDM) of adalimumab — drug: In the TDM-group, the adalimumab dose will be adjusted according to the following algorithms in order to keep the drug level within the therapeutic range: * Serum drug level within therapeutic range : keep dose * Low drug levels, ADAb undetectable or low levels : Decrease dosing interval by one week to a maximum of 40 mg/week * Low drug levels, ADAb high levels : Switch to another therapy * High drug levels : Increase dosing interval by one week up to a maximum of 6 weeks
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 74 Years
- Who
- All
- Number of participants
- 387
- Started
- 2024-08-20
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for rheumatoid arthritis
- • Phase4 - 387 participants
- • The goal of this clinical trial is to compare therapeutic drug monitoring (TDM) versus Standard of care in patients with rheumatoid arthritis treated with a subcutaneous tumor necrosis factor inhibitor (adalimumab)
Who can take part?
- • Ages 18 Years to 74 Years
- • Diagnosed with rheumatoid arthritis
Where?
- • London - Queen Mary
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The goal of this clinical trial is to compare therapeutic drug monitoring (TDM) versus Standard of care in patients with rheumatoid arthritis treated with a subcutaneous tumor necrosis factor inhibitor (adalimumab). The main question it aims to answer is: Is TDM superior to standard of care in order to maintain sustained disease control without flares? Participants will be followed with blood sampling every second month, measuring serum drug levels and anti-drug antibodies of the TNFi. In the TDM-group, the researchers will adjust the dosage of the TNFi based on knowledge on optimal therapeutic ranges. In the Standard of care group, the TNFi will be administered according to standard of care without knowledge of serum drug levels or anti-drug antibodies.
More detail
There is a considerable variation in serum drug levels among rheumatoid arthritis (RA) patients on tumor necrosis factor inhibitors (TNFi), and a high number develop neutralizing anti-drug antibodies (ADAb). Sub-therapeutic drug levels and ADAb formation are major contributors to TNFi treatment failure and disease flare. Proactive therapeutic drug monitoring (TDM), i.e., individualized drug dosing based on regular assessments of serum drug levels and ADAb, has the potential to optimize the efficacy and safety of TNFi treatment. The aim of the RA-DRUM trial is to assess whether TDM is superior to standard of care in order to maintain sustained disease control without flares in patients with RA treated with the SC TNFi adalimumab. Participants will be randomized to: * Administration of TNFi based on proactive TDM (TDM group) * Administration of TNFi based on standard of care without knowledge of serum drug levels or ADAb status (Standard of care group) Participants will be followed for 18 months with on-site visits at baseline, 4, 8, 12 and 18 months and digital visits at 2, 6, 10, 14, and 16 months. Blood sampling for serum drug levels and anti-drug antibodies will be done at all visits.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 74 Years
- Who can join: All genders
What the study is looking for
- ✓A clinical diagnosis of RA
- ✓≥ 18 and under 75 years of age at screening
- ✓On stable therapy with standard dose of a SC TNFi (adalimumab) for a minimum of 3 months and a maximum of 24 months
- ✓In low disease activity or remission (DAS28-CRP under 3.2) and indication for continuation of treatment according to...
- ✓Subject capable of understanding and signing an agreement to take part form
Who cannot take part
- ✗Hypersensitivity to sc TNFi (adalimumab).
- ✗Pregnancy, or subject considering becoming pregnant during the study period
- ✗Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers, or other factors that...
- ✗Changes in csDMARD co-medication, including dose changes of csDMARD or changes in the dose of corticosteroids within...
- ✗Co-medication with bDMARD, tsDMARD, or other immunosuppressive drugs (excluding csDMARD and corticosteroids ≤ 7.5 mg...
See the full criteria
Where Is This Study? (1 UK site)
Queen Mary
London SW15 5PN, United Kingdom
