CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 93 enrolled
Drug / intervention
Thalidomide +2 moredrug
Likely dose
Thalidomide 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03122431
NCT03122431Phase 4Completed

Relevance of Monitoring Blood Levels Compared to Salivar Levels of Drugs Used in Rheumatic Autoimmune Diseases: Adherence and Understanding the Possible Underlying Mechanisms Involved in Effectiveness and in Adverse Effects

University of Sao Paulo General Hospital·interventional·Posted Apr 20, 2017·Updated Dec 16, 2021

In Brief

A Phase 4 clinical trial evaluating Thalidomide, Hydroxychloroquine reduced, and 1 other intervention for Systemic Lupus Erythematosus (SLE) and 2 related conditions. Completed, enrolled 93 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedApr 20, 2017
Enrollment StartJun 5, 2017
Primary CompletionDec 30, 2020
Study CompletionMar 30, 2021
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 9.2 years ago

Interventions

Thalidomidedrug

Thalidomide 100 mg/day

Hydroxychloroquine reduceddrug

Hydroxychloroquine 2.5 mg/kg/day

standard dose of HCQdrug

Hydroxychloroquine 5.0 mg/kg/day