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)

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.

NCT Number	NCT06440629
Lead Sponsor	Diakonhjemmet Hospital Collaborators: Oslo University Hospital, Karolinska University Hospital, Queen Mary University of London, Medical University of Vienna, Alesund Hospital, St. Olavs Hospital, Helse Stavanger HF, Drammen sykehus, University Hospital of North Norway, Førde Hospital Trust, Hospital of Southern Norway Trust, Haukeland University Hospital, Ostfold Hospital Trust, Lillehammer Hospital for Rheumatic Diseases, Vestre Viken Hospital Trust, Haugesund Rheumatism Hospital, Betanien Hospital, Helgeland Hospital Trust, Nordlandssykehuset HF, Carol Davila University of Medicine and Pharmacy, Humanitas Research Hospital IRCCS, Rozzano-Milan, Sahlgrenska University Hospital
Conditions	Rheumatoid Arthritis
Enrollment	387 participants
Start Date	2024-08-20
Primary Completion	2027-12-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-01