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)

Prior treatment

• Changes in csDMARD co-medication, including dose changes of csDMARD or changes in the dose of corticosteroids within the last 2 months
• Co-medication with bDMARD, tsDMARD, or other immunosuppressive drugs (excluding csDMARD and corticosteroids ≤ 7.5 mg prednisolone (or equivalent) once daily).
• In need of live vaccines during the study period

Other illness

• Major comorbidities, such as previous malignancies within the last 5 years, uncontrolled diabetes mellitus, severe infections (including HIV), uncontrollable hypertension, severe cardiovascular disease (NYHA class 3 or 4), severe respiratory diseases, demyelinating disease, significant chronic widespread pain syndrome, significant renal or hepatic disease, and/or other diseases or conditions which either contraindicate treatment with SC TNFi or make adherence to the protocol difficult
• Hypersensitivity to SC TNFi (adalimumab)
• Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers, or other factors that makes adherence to the study protocol difficult

Other

• Pregnancy, or subject considering becoming pregnant during the study period
• Active participation in any other interventional study

• A clinical diagnosis of RA
• ≥ 18 and < 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 < 3.2) and indication for continuation of treatment according to the treating physician
• Subject capable of understanding and signing an informed consent form