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)
Key facts
- Where
- Aalesund, Bergen, Bodo, Drammen, Foerde, Fredrikstad, Gjettum, Haugesund, Kristiansand S, Lillehammer, Mo I Rana, Oslo, Skien, Stavanger, Tromsoe és Trondheim, NorvégiaSee the 16 sites
- Phase
- 4. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Norvégia
- Helse Moere Og Romsdal HFAalesund, NorvégiaNo longer taking part
- Helse Bergen HFBergen, NorvégiaNo longer taking part
- Nordlandssykehuset HFBodo, NorvégiaNo longer taking part
- Drammen SykehusDrammen, NorvégiaNo longer taking part
- Helse Forde HFFoerde, NorvégiaNo longer taking part
- Ostfold Hospital TrustFredrikstad, NorvégiaNo longer taking part
- Martina Hansens Hospital ASGjettum, NorvégiaNo longer taking part
- Haugesund Sanitetsforenings Revmatismesykehus ASHaugesund, NorvégiaNo longer taking part
- Sorlandet Sykehus HFKristiansand S, NorvégiaNo longer taking part
- Revmatismesykehuset ASLillehammer, NorvégiaNo longer taking part
- Helgelandssykehuset HFMo I Rana, NorvégiaNo longer taking part
- Diakonhjemmet Sykehus ASOslo, NorvégiaNo longer taking part
- Betanien HospitalSkien, NorvégiaNo longer taking part
- Helse Stavanger HFStavanger, NorvégiaNo longer taking part
- Universitetssykehuset Nord-Norge HFTromsoe, NorvégiaNo longer taking part
- St. Olavs hospital HFTrondheim, NorvégiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Diakonhjemmet Sykehus AS
- Trial code
- EU 2023-510184-35-00
- Record updated
- 2026. május 11.
- Original description
To assess whether proactive TDM is superior to standard of care in order to maintain sustained disease control without flares in patients with RA treated with SC TNFi.Read full original descriptionShow less
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
To assess whether proactive TDM is superior to standard of care in order to maintain sustained disease control without flares in patients with RA treated with SC TNFi.
Inclusion: A clinical diagnosis of RA; ≥ 18 and < 75 years of age at screening; On stable therapy with standard dose of a SC TNFi (adalimumab) for a minimum of 3 months and a maximum of 24 months; In low disease activity or remission (DAS28-CRP < 3.2) and indication for continuation of treatment according to the treating physician; Subject capable of understanding and signing an informed consent form.
Exclusion: Changes in csDMARD co-medication, including dose changes of csDMARD or changes in the dose of corticosteroids within the last 2 months; Co-medication with bDMARD, tsDMARD, or other immunosuppressive drugs (excluding csDMARD and corticosteroids ≤ 7.5 mg prednisolone (or equivalent) once daily); In need of live vaccines during the study period; Major comorbidities, such as previous malignancies within the last 5 years, uncontrolled diabetes mellitus, severe infections (including HIV), uncontrollable hypertension, severe cardiovascular disease (NYHA class 3 or 4), severe respiratory diseases, demyelinating disease, significant chronic widespread pain syndrome, significant renal or hepatic disease, and/or other diseases or conditions which either contraindicate treatment with SC TNFi or make adherence to the protocol difficult; Hypersensitivity to SC TNFi (adalimumab); Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers, or other factors that makes adherence to the study protocol difficult; Pregnancy, or subject considering becoming pregnant during the study period; Active participation in any other interventional study.