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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)

Study acronym: RA-DRUM
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial status changed: Recruiting → Active, Not Recruiting
    • Enrollment increased: 350 → 387 participants
    • Site details revised at 22 of 22 sites
    v10
  2. Site details revised at 1 of 22 sitesv9
  3. Study sites: 21 to 22
    • Collaborators: 20 to 22
    v8
  4. Site details revised at 1 of 21 sitesv7
  5. Site details revised at 2 of 21 sitesv6
Show 4 earlier versionsHide 4 earlier versions
  1. Collaborators revised (20)v5
  2. Study sites: 20 to 21v4
  3. Study sites: 19 to 20
    • Collaborators: 19 to 20
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 15, 2024 to Aug 20, 2024
    • Site details revised at 19 of 19 sites
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
(from sponsor)		 Rheumatoid Arthritis
Related terms Arthritis, Rheumatoid
Enrollment 387 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov