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)
NCT ID: NCT06440629
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
350 participants
INTERVENTIONAL
2024-08-20
2027-12-31
Brief Summary
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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.
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Detailed Description
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The aim of the RA-DRUM trial is to assess whether TDM is superior to standard of care in order to maintain sustained disease control without flares in patients with RA treated with the SC TNFi adalimumab.
Participants will be randomized to:
* Administration of TNFi based on proactive TDM (TDM group)
* Administration of TNFi based on standard of care without knowledge of serum drug levels or ADAb status (Standard of care group)
Participants will be followed for 18 months with on-site visits at baseline, 4, 8, 12 and 18 months and digital visits at 2, 6, 10, 14, and 16 months. Blood sampling for serum drug levels and anti-drug antibodies will be done at all visits.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TDM-group
In the TDM-group, the TNFi dose will be adjusted in order to keep the drug level within the therapeutic range
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
Standard of Care group
In the Standard of Care group, TNFi will be administered according to standard of care without knowledge of serum drug levels or ADAb
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. ≥ 18 and under 75 years of age at screening
3. On stable therapy with standard dose of a SC TNFi (adalimumab) for a minimum of 3 months and a maximum of 24 months
4. In low disease activity or remission (DAS28-CRP under 3.2) and indication for continuation of treatment according to the treating physician
5. Subject capable of understanding and signing an informed consent form
Exclusion Criteria
2. Hypersensitivity to sc TNFi (adalimumab).
3. Pregnancy, or subject considering becoming pregnant during the study period
4. Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers, or other factors that makes adherence to the study protocol difficult
5. Changes in csDMARD co-medication, including dose changes of csDMARD or changes in the dose of corticosteroids within the last 2 months
6. Co-medication with bDMARD, tsDMARD, or other immunosuppressive drugs (excluding csDMARD and corticosteroids ≤ 7.5 mg prednisolone (or equivalent) once daily).
7. Active participation in any other interventional study.
8. In need of live vaccines during the study period.
18 Years
74 Years
ALL
No
Sponsors
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Oslo University Hospital
OTHER
Karolinska University Hospital
OTHER
Queen Mary University of London
OTHER
Medical University of Vienna
OTHER
Alesund Hospital
OTHER
St. Olavs Hospital
OTHER
Helse Stavanger HF
OTHER_GOV
Drammen sykehus
OTHER
University Hospital of North Norway
OTHER
Førde Hospital Trust
OTHER
Hospital of Southern Norway Trust
OTHER
Haukeland University Hospital
OTHER
Ostfold Hospital Trust
OTHER
Lillehammer Hospital for Rheumatic Diseases
OTHER
Vestre Viken Hospital Trust
OTHER
Haugesund Rheumatism Hospital
OTHER
Betanien Hospital
OTHER
Helgeland Hospital Trust
OTHER
Nordlandssykehuset HF
OTHER
Carol Davila University of Medicine and Pharmacy
OTHER
Humanitas Research Hospital IRCCS, Rozzano-Milan
OTHER
Sahlgrenska University Hospital
OTHER
Diakonhjemmet Hospital
OTHER
Responsible Party
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Principal Investigators
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Espen A Haavardsholm, Phd, MD
Role: STUDY_DIRECTOR
Diakonhjemmet Hospital
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Elisa Gremese, MD PhD
Role: primary
Anna Karin Ekwall, MD, PhD
Role: primary
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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EU CT No 2023-510184-35-00
Identifier Type: -
Identifier Source: org_study_id
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