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)

• Status: RECRUITING
• Trial end date: 2027-12-31

Summary

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.

• Phase: PHASE4

Details

• Lead Sponsor: Diakonhjemmet Hospital
• Collaborators: Alesund Hospital; Betanien Hospital; Carol Davila University of Medicine and Pharmacy; Drammen sykehus; Førde Hospital Trust; Haugesund Rheumatism Hospital; Haukeland University Hospital; Helgeland Hospital Trust; Helse Stavanger HF; Hospital of Southern Norway Trust; Karolinska University Hospital; Lillehammer Hospital for Rheumatic Diseases; Martina Hansen's Hospital; Medical University of Vienna; Nordlandssykehuset HF; Oslo University Hospital; Ostfold Hospital Trust; Queen Mary University of London; St. Olavs Hospital; University Hospital of North Norway
• Treatments: Adalimumab