RA-DRUM
Research type
Research Study
Full title
A multi-center, open, randomized, 18-month, parallel-group, superiority study to compare the effect of proactive therapeutic drug monitoring versus standard of care with regards to maintenance of sustained disease control without flare in adults with rheumatoid arthritis treated with a subcutaneous tumor necrosis factor inhibitor.
IRAS ID
1011094
Contact name
Espen Haavardsholm
Contact email
Sponsor organisation
Diakonhjemmet Hospital AS
Eudract number
2023-510184-35
Clinicaltrials.gov Identifier
Research summary
The RA-DRUM trial is a clinical study designed to help improve treatment for adults with rheumatoid arthritis (RA), a condition where
the immune system attacks the joints, causing pain and potential long-term damage. Many RA patients are treated with medications
called tumor necrosis factor inhibitors (TNFi), such as adalimumab. These medications reduce inflammation and aim to prevent
disease flare-ups. However, patients respond to TNFi in different ways, and some develop antibodies that make the drugs less
effective over time.
The RA-DRUM trial will investigate whether a personalized treatment approach called Therapeutic Drug Monitoring (TDM) can help
patients stay flare-free longer compared to the current standard approach. TDM involves adjusting medication doses based on
regular blood tests that measure drug levels and antibodies in each patient’s system. By tailoring the dose to each person’s needs,
researchers believe this approach may improve disease control, reduce side effects, and potentially lower healthcare costs.
This study will run for 18 months and will include 350 RA patients already taking adalimumab. Participants will be randomly assigned
to one of two groups: one group will have their doses adjusted based on regular blood tests (TDM group), while the other group will
continue with standard care without these adjustments (standard care group). Both groups will attend regular visits to monitor their
condition.
The trial aims to find out if using TDM can help RA patients avoid flare-ups, improve quality of life, and possibly make TNFi
treatments more affordable and effective.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
25/NE/0076
Date of REC Opinion
9 Jun 2025
REC opinion
Further Information Favourable Opinion