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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
543
versus hydroxychloroquine
Chu Pitie Salpetriere
Paris, France
Hopital la Pitié Salpétrière Assistance Publique
Paris, France
The number of patient in each group who developed a flare (according to the SELENA-SLEDAI composite criteria) during the study period.
The number of patient in each group who developed a flare (according to the SELENA-SLEDAI composite criteria) during the study period.
Time frame: 7 months of follow up
The number of patients in each group who developed a flare during the study period.
The number of patients in each group who developed a flare during the study period.
Time frame: 7 months of follow up
The total number of flares in each group
The total number of flares in each group
Time frame: 7 months of follow up
the total dose of steroids in each group
the total dose of steroids in each group
Time frame: 7 months of follow up
the area under the curve of SELENA SLEDAI in each group
the area under the curve of SELENA SLEDAI in each group
Time frame: 7 months of follow up
the mean change of the quality of life questionnaire SF-36
the mean change of the quality of life questionnaire SF-36
Time frame: 7 months of follow up
the mean change on the score of analogical visual scale in each group
the mean change on the score of analogical visual scale in each group
Time frame: 7 months of follow up
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Treatment tolerance evaluation will include clinical, electrocardiographic and ophthalmologic screening.
Treatment tolerance evaluation will include clinical, electrocardiographic and ophthalmologic screening.
Time frame: 7 months of follow up