Description Module

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Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module

Ignite Creation Date: 2025-12-24 @ 12:22 PM
Ignite Modification Date: 2025-12-24 @ 12:22 PM
NCT ID: NCT00413361
Brief Summary: The main objective of study PLUS is to determine the potential benefits of individualized HCQ dosing schedules aimed at maintaining the whole-blood HCQ concentration above 1000 ng/ml
Detailed Description: Hydroxychloroquine (HCQ) is a treatment which allows preventing Systemic Lupus Erythematosus (SLE) exacerbations. HCQ can be measured in whole-blood by HPLC (High Performance Liquid Chromatography). Interindividual variability in blood HCQ concentrations is important and a correlation between HCQ level and clinical efficacy of HCQ has been demonstrated in SLE in a monocentric study of 143 unselected SLE patients. The main objective of study PLUS is to determine the potential benefits of individualized HCQ dosing schedules aimed at maintaining the whole-blood HCQ concentration above 1000 ng/ml The secondary objectives are: * To define biological and clinical hallmarks present at M1 (month 1) which are predictor of SLE exacerbations in the next 6 month, * To establish the parameters of HCQ pharmacokinetic model, by a study of population, using a "Bayésienne" approach. * To study the influence of allelic variants of drug carriers and other genes in the interindividual variability of blood HCQ concentrations. * To study the influence of the compliance in the blood HCQ concentration variability * To study the relation between blood HCQ concentrations, SLE activity and quality of life * To study the relation between blood HCQ concentrations, SLE activity and lipid profile of the patients * To study the relation between ECG abnormalities and blood HCQ concentrations * To constitute a bank of serum, a DNAbank, and a RNAbank to permit subsequent studies
Study: NCT00413361
Study Brief:
Protocol Section: NCT00413361