Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-27 @ 9:33 PM
Study NCT ID:
NCT00413361
Status:
COMPLETED
Last Update Posted:
2011-01-27
First Post:
2006-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Reduction of Systemic Lupus Erythematosus Flares :Study PLUS
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Study of the Reduction of Systemic Lupus Erythematosus Flares Through Adaptation of the Dosage of Hydroxychloroquine to Its Whole-blood Concentration. National Multicenter Randomized Prospective Study
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: