Proactive drug monitoring for rheumatoid arthritis treatment

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

This study is testing if regular blood tests to adjust medication doses can help people with rheumatoid arthritis using adalimumab feel better and avoid flare-ups compared to standard care.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 350 (estimated)
• Ages: 18 Years to 74 Years
• Sex: All
• Sponsor: Diakonhjemmet Hospital (other)
• Drugs / interventions: adalimumab
• Locations: 22 sites (Vienna and 21 other locations)
• Trial ID: NCT06440629 on ClinicalTrials.gov

What this trial studies

This clinical trial compares proactive therapeutic drug monitoring (TDM) with standard care in adults with rheumatoid arthritis receiving a subcutaneous tumor necrosis factor inhibitor (adalimumab). Participants will be randomized into two groups: one receiving TDM, where drug dosages are adjusted based on regular blood tests measuring drug levels and anti-drug antibodies, and the other receiving standard care without such monitoring. The study aims to determine if TDM can maintain sustained disease control and reduce flares over an 18-month period. Participants will have regular on-site and digital visits for monitoring and blood sampling.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a clinical diagnosis of rheumatoid arthritis who are on stable therapy with adalimumab and in low disease activity or remission.

Not a fit: Patients with major comorbidities or hypersensitivity to adalimumab may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved disease control and fewer flares for patients with rheumatoid arthritis.

How similar studies have performed: Previous studies have shown promise for therapeutic drug monitoring in optimizing treatment for rheumatoid arthritis, indicating potential success for this approach.

Eligibility 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 this trial is running

Vienna and 21 other locations

• Medical University Vienna — Vienna, Austria (RECRUITING)
• Humanitas Research Hospital — Milan, Italy (RECRUITING)
• Diakonhjemmet sykehus — Oslo, N-0319, Norway (RECRUITING)
• Ålesund Hospital — Ålesund, Norway (RECRUITING)
• Haukeland University Hospital — Bergen, Norway (RECRUITING)
• Nordland Hospital Trust — Bodø, Norway (RECRUITING)
• Drammen Hospital — Drammen, Norway (RECRUITING)
• Førde Hospital Trust — Førde, Norway (RECRUITING)
• Haugesund Rheumatism Hospital — Haugesund, Norway (RECRUITING)
• Hospital of Southern Norway Trust — Kristiansand, Norway (RECRUITING)
• Lillehammer Hospital for Rheumatic Diseases — Lillehammer, Norway (RECRUITING)
• Helgeland Hospital Trust — Mo i Rana, Norway (RECRUITING)
• Østfold Hospital Trust — Moss, Norway (RECRUITING)
• Martina Hansen's Hospital — Sandvika, Norway (RECRUITING)
• Betanien Hospital — Skien, Norway (RECRUITING)
• Stavanger University Hospital — Stavanger, Norway (RECRUITING)
• University Hospital of North Norway — Tromsø, Norway (RECRUITING)
• St.Olavs Hospital — Trondheim, Norway (RECRUITING)
• Carol Davila University of Medicine and Pharmacy Bucharest — Bucharest, Romania (RECRUITING)
• Sahlgrenska Universitetssjukehuset — Gothenburg, Sweden (RECRUITING)
• Karolinska University Hospital — Stockholm, Sweden (RECRUITING)
• Queen Mary — London, SW15 5PN, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: Ingrid Jyssum, PhD, MD

Conditions: Rheumatoid Arthritis, Rheumatoid arthritis, Therapeutic drug monitoring, Tumor necrosis factor inhibitor