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)

Last updated: April 9, 2025
Sponsor: Diakonhjemmet Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Rheumatoid Arthritis

Joint Injuries

Dermatomyositis (Connective Tissue Disease)

Treatment

Therapeutic drug monitoring (TDM) of adalimumab

Clinical Study ID

NCT06440629
EU CT No 2023-510184-35-00
  • Ages 18-74
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 3months and a maximum of 24 months

  4. In low disease activity or remission (DAS28-CRP under 3.2) and indication forcontinuation of treatment according to the treating physician

  5. Subject capable of understanding and signing an informed consent form

Exclusion

Exclusion Criteria:

  1. Major comorbidities, such as previous malignancies within the last 5 years,uncontrolled diabetes mellitus, severe infections (including HIV), uncontrollablehypertension, severe cardiovascular disease (NYHA class 3 or 4), severe respiratorydiseases, demyelinating disease, significant chronic widespread pain syndrome,significant renal or hepatic disease, and/or other diseases or conditions whicheither contraindicate treatment with SC TNFi or make adherence to the protocoldifficult

  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, languagebarriers, or other factors that makes adherence to the study protocol difficult

  5. Changes in csDMARD co-medication, including dose changes of csDMARD or changes inthe dose of corticosteroids within the last 2 months

  6. Co-medication with bDMARD, tsDMARD, or other immunosuppressive drugs (excludingcsDMARD 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.

Study Design

Total Participants: 350
Treatment Group(s): 1
Primary Treatment: Therapeutic drug monitoring (TDM) of adalimumab
Phase: 4
Study Start date:
August 20, 2024
Estimated Completion Date:
December 31, 2027

Study Description

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.

Connect with a study center

  • Medical University Vienna

    Vienna, A-1090
    Austria

    Active - Recruiting

  • Diakonhjemmet sykehus

    Oslo, N-0319 0319
    Norway

    Active - Recruiting

  • Haukeland University Hospital

    Bergen, 5009
    Norway

    Active - Recruiting

  • Nordland Hospital Trust

    Bodø, 8005
    Norway

    Active - Recruiting

  • Drammen Hospital

    Drammen, 3004
    Norway

    Active - Recruiting

  • Førde Hospital Trust

    Førde, 6812
    Norway

    Active - Recruiting

  • Haugesund Rheumatism Hospital

    Haugesund, 5528
    Norway

    Active - Recruiting

  • Hospital of Southern Norway Trust

    Kristiansand, 4615
    Norway

    Active - Recruiting

  • Lillehammer Hospital for Rheumatic Diseases

    Lillehammer, 2609
    Norway

    Active - Recruiting

  • Helgeland Hospital Trust

    Mo I Rana, 8613
    Norway

    Active - Recruiting

  • Østfold Hospital Trust

    Moss, 1535
    Norway

    Active - Recruiting

  • Martina Hansen's Hospital

    Sandvika,
    Norway

    Active - Recruiting

  • Betanien Hospital

    Skien, 3722
    Norway

    Active - Recruiting

  • Stavanger University Hospital

    Stavanger, 4019
    Norway

    Active - Recruiting

  • University Hospital of North Norway

    Tromsø, 9019
    Norway

    Active - Recruiting

  • St.Olavs Hospital

    Trondheim, 7030
    Norway

    Active - Recruiting

  • Ålesund Hospital

    Ålesund, 6017
    Norway

    Active - Recruiting

  • Carol Davila University of Medicine and Pharmacy Bucharest

    Bucharest,
    Romania

    Active - Recruiting

  • Sahlgrenska Universitetssjukehuset

    Gothenburg, 41345
    Sweden

    Active - Recruiting

  • Karolinska University Hospital

    Stockholm, 141 86
    Sweden

    Active - Recruiting

  • Queen Mary

    London, Sw15 5pn SW15 5PN
    United Kingdom

    Site Not Available

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