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)

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.

Conditions

• Rheumatoid Arthritis

Interventions

DRUG

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

Sponsors & Collaborators

• Oslo University Hospital

  collaborator OTHER

• Karolinska University Hospital

  collaborator OTHER

• Queen Mary University of London

  collaborator OTHER

• Medical University of Vienna

  collaborator OTHER

• Alesund Hospital

  collaborator OTHER

• St. Olavs Hospital

  collaborator OTHER

• Helse Stavanger HF

  collaborator OTHER_GOV

• Drammen sykehus

  collaborator OTHER

• University Hospital of North Norway

  collaborator OTHER

• Førde Hospital Trust

  collaborator OTHER

• Hospital of Southern Norway Trust

  collaborator OTHER

• Haukeland University Hospital

  collaborator OTHER

• Ostfold Hospital Trust

  collaborator OTHER

• Lillehammer Hospital for Rheumatic Diseases

  collaborator OTHER

• Vestre Viken Hospital Trust

  collaborator OTHER

• Haugesund Rheumatism Hospital

  collaborator OTHER

• Betanien Hospital

  collaborator OTHER

• Helgeland Hospital Trust

  collaborator OTHER

• Nordlandssykehuset HF

  collaborator OTHER

• Carol Davila University of Medicine and Pharmacy

  collaborator OTHER

• Humanitas Research Hospital IRCCS, Rozzano-Milan

  collaborator OTHER

• Sahlgrenska University Hospital

  collaborator OTHER

• Diakonhjemmet Hospital

  lead OTHER

Principal Investigators

• Espen A Haavardsholm, Phd, MD · Diakonhjemmet Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

74 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-20

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• Austria
• Italy
• Norway
• Romania
• Sweden
• United Kingdom

Study Locations