Optimizing adalimumab dosing for rheumatoid arthritis using drug monitoring
Adalimumab Drug Optimisation in Rheumatoid Arthritis Using Therapeutic Drug Monitoring (ADDORA): Multi-centre Open Label Randomised Controlled Trail
This study is testing if checking drug levels can help people with rheumatoid arthritis get the right dose of adalimumab to feel better while reducing side effects and costs.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 267 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Reade Rheumatology Research Institute Academic / other |
| Drugs / interventions | adalimumab |
| Locations | 1 site (Amsterdam, Noord Holland) |
| Trial ID | NCT04194827 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of therapeutic drug monitoring (TDM) for optimizing adalimumab dosing in patients with rheumatoid arthritis. It aims to compare a dose reduction strategy based on serum drug levels against the traditional method of using disease activity scores. By determining the optimal drug concentration needed to maintain clinical efficacy, the study seeks to minimize side effects and reduce treatment costs. Participants will be monitored over time to assess the impact of these dosing strategies on disease management.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are starting adalimumab as their first biological therapy for rheumatoid arthritis.
Not a fit: Patients with other diseases that may flare if adalimumab is tapered, or those with a life expectancy shorter than the study follow-up period, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more cost-effective treatment options for patients with rheumatoid arthritis.
How similar studies have performed: Previous studies have shown promise in using therapeutic drug monitoring for biologics, suggesting that this approach could be beneficial, although it is still a relatively novel application in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Rheumatoid arthritis patient, according to ACR 1987 or ACR/EULAR 2010 criteria; * Starting adalimumab as the first biological therapy * Who has agreed to participate (written informed consent); * Age 18 years or older. Exclusion Criteria: * Scheduled surgery during the follow-up of the study or other pre-planned reasons for treatment discontinuation; * Life expectancy shorter than follow-up period of the study; * Other disease that might flare if adalimumab is tapered like psoriasis, inflammatory bowel disease.
Where this trial is running
Amsterdam, Noord Holland
- Reade Rheumatology Research Institute — Amsterdam, Noord Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Gertjan Wolbink, PhD — Reade Rheumatology Research Institute
- Study coordinator: Sadaf Atiqi, MD
- Email: s.atiqi@reade.nl
- Phone: 0031-202421641
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.