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RECRUITING
NCT06440629
PHASE4

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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