Actively Recruiting
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)
Led by Diakonhjemmet Hospital · Updated on 2026-02-05
350
Participants Needed
22
Research Sites
175 weeks
Total Duration
On this page
Sponsors
D
Diakonhjemmet Hospital
Lead Sponsor
O
Oslo University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A clinical diagnosis of rheumatoid arthritis
- Age 18 to under 75 years at screening
- On a stable standard dose of subcutaneous adalimumab for 3 to 24 months
- Currently in low disease activity or remission (DAS28-CRP under 3.2) with doctor indication to continue treatment
- Able to understand and sign informed consent
You will not qualify if you...
- Major comorbidities such as recent cancer, uncontrolled diabetes, severe infections including HIV, severe cardiovascular or respiratory disease, demyelinating disease, chronic widespread pain, or significant liver or kidney disease
- Hypersensitivity to subcutaneous adalimumab
- Pregnancy or planning pregnancy during the study
- Psychiatric issues, substance abuse, language barriers, or other factors limiting study adherence
- Changes in conventional DMARDs or corticosteroid doses in last 2 months
- Use of other biologic or targeted DMARDs or immunosuppressives (except low-dose corticosteroids)
- Participation in another interventional study
- Need for live vaccines during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
Medical University Vienna
Vienna, Austria, A-1090
Actively Recruiting
2
Humanitas Research Hospital
Milan, Italy
Actively Recruiting
3
Diakonhjemmet sykehus
Oslo, N-0319, Norway, 0319
Actively Recruiting
4
Ålesund Hospital
Ålesund, Norway, 6017
Actively Recruiting
5
Haukeland University Hospital
Bergen, Norway, 5009
Actively Recruiting
6
Nordland Hospital Trust
Bodø, Norway, 8005
Actively Recruiting
7
Drammen Hospital
Drammen, Norway, 3004
Actively Recruiting
8
Førde Hospital Trust
Førde, Norway, 6812
Actively Recruiting
9
Haugesund Rheumatism Hospital
Haugesund, Norway, 5528
Actively Recruiting
10
Hospital of Southern Norway Trust
Kristiansand, Norway, 4615
Actively Recruiting
11
Lillehammer Hospital for Rheumatic Diseases
Lillehammer, Norway, 2609
Actively Recruiting
12
Helgeland Hospital Trust
Mo i Rana, Norway, 8613
Actively Recruiting
13
Østfold Hospital Trust
Moss, Norway, 1535
Actively Recruiting
14
Martina Hansen's Hospital
Sandvika, Norway
Actively Recruiting
15
Betanien Hospital
Skien, Norway, 3722
Actively Recruiting
16
Stavanger University Hospital
Stavanger, Norway, 4019
Actively Recruiting
17
University Hospital of North Norway
Tromsø, Norway, 9019
Actively Recruiting
18
St.Olavs Hospital
Trondheim, Norway, 7030
Actively Recruiting
19
Carol Davila University of Medicine and Pharmacy Bucharest
Bucharest, Romania
Actively Recruiting
20
Sahlgrenska Universitetssjukehuset
Gothenburg, Sweden, 41345
Actively Recruiting
21
Karolinska University Hospital
Stockholm, Sweden, 141 86
Actively Recruiting
22
Queen Mary
London, SW15 5PN, United Kingdom, SW15 5PN
Actively Recruiting
Research Team
I
Ingrid Jyssum, PhD, MD
CONTACT
S
Silje W Syversen, PhD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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