Effect of Proactive Therapeutic Drug Monitoring on Maintenance of Sustained Disease Control in Adults With Rheumatoid Arthritis on a Subcutaneous TNF Inhibitor: The Rheumatoid Arthritis Therapeutic DRUg Monitoring Trial (RA-DRUM)

To join this study, you need to be an adult between 18 and 74 years old and have a confirmed diagnosis of rheumatoid arthritis. You should already be taking adalimumab (a type of TNF inhibitor given by injection) at a steady dose for at least three months, but no longer than two years. Importantly, your rheumatoid arthritis should currently be well-controlled with low disease activity or in remission, meaning you're not experiencing significant symptoms.

There are several reasons why you might not be able to join. For example, if you have other serious health conditions like certain cancers, severe heart or breathing problems, or uncontrolled diabetes. Also, if you're pregnant, planning to become pregnant, or have conditions that would make it difficult for you to follow the study's instructions, you wouldn't be able to take part. This includes certain mental health conditions, alcohol or drug abuse, or language barriers.

Finally, if you've had certain changes to other arthritis medications recently, are taking other specific types of arthritis drugs, or are involved in another medical study, you wouldn't be eligible. The research team needs to make sure the study can be carried out safely and effectively, and that your participation won't put your health at risk or interfere with other treatments.

If you decide to take part in this study, it will last for 18 months. You’ll be asked to visit the study site for appointments five times: when you first join, and then at 4, 8, 12, and 18 months. In between these visits, you’ll also have five shorter appointments that can be done digitally (online or over the phone) at 2, 6, 10, 14, and 16 months.

At every single one of these eleven appointments – both the in-person and digital ones – you'll have a blood sample taken. These blood samples are important for checking your adalimumab drug levels and seeing if your body has made any antibodies against the drug. If you're in the group receiving care guided by these blood tests, your doctor might adjust your adalimumab dose based on these results. If you're in the standard care group, your dose will be managed as usual, without knowing these blood test results.

Your adalimumab medication will continue to be administered as an injection under the skin, as you typically take it. The total duration of your active involvement in the study, from your first visit to your last, will be 18 months.