drugset / Trial / NCT05683054

A Non-inferiority Study on Dose Reduction of Adalimumab in Psoriasis Patients Who Are Overtreated

NCT05683054

Phase 4 Completed 19 enrolled University Hospital, Ghent KU Leuven · collab
RandomizedParallel-groupSingle-blindTreatment

Summary

Recently, the optimal therapeutic serum trough level range of adalimumab was defined between 3,5 and 7,0 µg/ml in patients with plaque type psoriasis. An adalimumab serum through level above this therapeutic range did not add to clinical response. Based on this therapeutic window, the introduction of dose adjustments based on serum trough levels (therapeutic drug monitoring) will be further validated in a prospective controlled trial. Here, we aim to determine whether, in patients with a good clinical response and supratherapeutic adalimumab STLs, dose reduction based on therapeutic drug monitoring (TDM) is able to maintain the initial clinical outcome.

Timeline

Start
2020-08-11
Primary completion
2022-03-22
Completion
2022-08-22

Drugs

EvaluationDrugModalityDoseRoute
Comparator Adalimumab Monoclonal antibody 40 mg Subcutaneous

Indications