Relevance of Monitoring Blood and Salivar Levels of Drugs Used in Rheumatic Autoimmune Diseases
Status:
Recruiting
Trial end date:
2022-06-05
Target enrollment:
Participant gender:
Summary
No drug treatment is completely free of risk and lack of response, adverse events and poor
adherence may affect its effectiveness. Within this context, this project aims to evaluate
the importance of monitoring blood levels and salivary drug used in rheumatic autoimmune
diseases in the monitoring of adherence to therapy. In addition, this project intends to use
the monitoring of drug levels, based on pharmacokinetic studies and
pharmacokinetics/pharmacodynamics modeling, to broaden the understanding of the possible
cellular, tissue and immunological mechanisms involved in efficacy and adverse effects of
these drugs with the prospect of reducing the damage and maintain therapeutic efficacy. The
high-performance liquid chromatography (HPLC) coupled to mass spectrometry, which will be
used to evaluate hydroxychloroquine, thalidomide, glucocorticoids, is considered the gold
standard technology to qualitative and quantitative analysis of drugs in blood and its
comparison with the dosage in the saliva is an improvement in simplification of the process.
For biological agents the focus will be on the understanding the loss of efficacy and the
possible role of anti-TNF antibodies using ELISA capture methodology.This project will be
divided into four sections with their respective sub-projects according to the medications
that will be studied: hydroxychloroquine, thalidomide, biologic agents and glucocorticoids.
Phase:
Phase 4
Details
Lead Sponsor:
University of Sao Paulo General Hospital
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo