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ACTIVE NOT RECRUITINGPhase4

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

NCT ID: NCT06440629

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Therapeutic drug monitoring (TDM) of adalimumab (drug)
How long the study runs
Study runs about 40 months (dates as stated)
About the drug or intervention
Therapeutic drug monitoring (TDM) of adalimumab — drug: 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
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 74 Years
Who
All
Number of participants
387
Started
2024-08-20
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for rheumatoid arthritis
  • • Phase4 - 387 participants
  • • 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)

Who can take part?

  • • Ages 18 Years to 74 Years
  • • Diagnosed with rheumatoid arthritis

Where?

  • • London - Queen Mary

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

There is a considerable variation in serum drug levels among rheumatoid arthritis (RA) patients on tumor necrosis factor inhibitors (TNFi), and a high number develop neutralizing anti-drug antibodies (ADAb). Sub-therapeutic drug levels and ADAb formation are major contributors to TNFi treatment failure and disease flare. Proactive therapeutic drug monitoring (TDM), i.e., individualized drug dosing based on regular assessments of serum drug levels and ADAb, has the potential to optimize the efficacy and safety of TNFi treatment. 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.

Rheumatoid Arthritis

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 74 Years
  • Who can join: All genders

What the study is looking for

  • ✓A clinical diagnosis of RA
  • ✓≥ 18 and under 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 under 3.2) and indication for continuation of treatment according to...
  • ✓Subject capable of understanding and signing an agreement to take part form

Who cannot take part

  • ✗Hypersensitivity to sc TNFi (adalimumab).
  • ✗Pregnancy, or subject considering becoming pregnant during the study period
  • ✗Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers, or other factors that...
  • ✗Changes in csDMARD co-medication, including dose changes of csDMARD or changes in the dose of corticosteroids within...
  • ✗Co-medication with bDMARD, tsDMARD, or other immunosuppressive drugs (excluding csDMARD and corticosteroids ≤ 7.5 mg...
See the full criteria
Inclusion Criteria: 1. A clinical diagnosis of RA 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: 1. 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 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.

Where Is This Study? (1 UK site)

Queen Mary

London SW15 5PN, United Kingdom

Hospital R&D contact (matched)

Dr Mays Jawad

research.governance@qmul.ac.uk020 7882 6826
Data sourced from ClinicalTrials.gov · Last verified: 2026-06