Clinical Research Directory
Browse clinical research sites, groups, and studies.
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)
Sponsor: Diakonhjemmet Hospital
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.
Official 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
Key Details
Gender
All
Age Range
18 Years - 74 Years
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2024-08-20
Completion Date
2027-12-31
Last Updated
2026-02-05
Healthy Volunteers
No
Conditions
Interventions
Therapeutic drug monitoring (TDM) of adalimumab
In the TDM-group, the adalimumab dose will be adjusted according to the following algorithms in order to keep the drug level within the therapeutic range: * Serum drug level within therapeutic range : keep dose * Low drug levels, ADAb undetectable or low levels : Decrease dosing interval by one week to a maximum of 40 mg/week * Low drug levels, ADAb high levels : Switch to another therapy * High drug levels : Increase dosing interval by one week up to a maximum of 6 weeks
Locations (22)
Medical University Vienna
Vienna, Austria
Humanitas Research Hospital
Milan, Italy
Diakonhjemmet sykehus
Oslo, N-0319, Norway
Ålesund Hospital
Ålesund, Norway
Haukeland University Hospital
Bergen, Norway
Nordland Hospital Trust
Bodø, Norway
Drammen Hospital
Drammen, Norway
Førde Hospital Trust
Førde, Norway
Haugesund Rheumatism Hospital
Haugesund, Norway
Hospital of Southern Norway Trust
Kristiansand, Norway
Lillehammer Hospital for Rheumatic Diseases
Lillehammer, Norway
Helgeland Hospital Trust
Mo i Rana, Norway
Østfold Hospital Trust
Moss, Norway
Martina Hansen's Hospital
Sandvika, Norway
Betanien Hospital
Skien, Norway
Stavanger University Hospital
Stavanger, Norway
University Hospital of North Norway
Tromsø, Norway
St.Olavs Hospital
Trondheim, Norway
Carol Davila University of Medicine and Pharmacy Bucharest
Bucharest, Romania
Sahlgrenska Universitetssjukehuset
Gothenburg, Sweden
Karolinska University Hospital
Stockholm, Sweden
Queen Mary
London, SW15 5PN, United Kingdom