Adalimumab Drug Optimisation in Rheumatoid Arthritis Using Therapeutic Drug Monitoring
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
Several prior studies have shown that dose reduction of Tumor Necrosis Factor
(TNF)-inhibitors like adalimumab is possible in substantial number of rheumatic disease
patients without an increase in disease activity. Biologic therapy is expensive, and is
associated with patient burden as dose dependant risk for serious infections . A dose
reduction will decrease the risk of side effects and result in substantial cost savings.
Currently, most clinicians use Disease Activity Score in 28 joints (DAS28) and the Clinical
Disease Activity Index (CDAI) to monitor dose tapering strategies. Although this approach is
cost-effective, it might be improved by information on the extent of drug levels, as several
studies have shown that adalimumab drug levels are associated with clinical outcome.
Therefore, a study comparing dose reduction strategy using drug concentration with dose
reduction strategy using disease activity is timely
Phase:
Phase 4
Details
Lead Sponsor:
Reade Rheumatology Research Institute
Collaborators:
Sint Maartenskliniek ZonMw: The Netherlands Organisation for Health Research and Development