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Sponsors and Collaborators: |
Assistance Publique - Hôpitaux de Paris Sanofi-Synthelabo |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00413361 |
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
Condition | Intervention | Phase |
---|---|---|
Systemic Lupus Erythematosus |
Drug: versus hydroxychloroquine |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Caregiver, Investigator), Dose Comparison, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 800 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | February 2011 |
Arms | Assigned Interventions |
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A: Placebo Comparator
placebo
|
Drug: versus hydroxychloroquine |
B: Experimental
versus hydroxychloroquine
|
Drug: versus hydroxychloroquine |
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:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
People profiting from a particular protection:
Criteria of inclusion at the visit of randomization (D0):
All the patients responding to the next criterions can be randomized:
Contact: Nathalie COSTEDOAT-CHALUMEAU, MD | +33 (0)-1 42 17 82 48 | nathalie.costedoat@psl.aphp.fr |
France | |
Chu Pitie Salpetriere | Recruiting |
PARIS, France, 75013 | |
Contact: Nathalie COSTEDOAT-CHALUMEAU, MD,PhD +33(0)- 1 42 17 82 48 nathalie.costedoat@psl.aphp.fr | |
Hopital la Pitié Salpétrière Assistance Publique | Recruiting |
Paris, France, 75013 | |
Contact: Jean Charles PIETTE, MdPh jcpiette@free.fr | |
Contact: Zahir AMOURA, MdPh zahir.amoura@psl.aphp.fr | |
Sub-Investigator: Philippe LECHAT, Md-Ph | |
Sub-Investigator: Jean Sébastien HULOT, Md |
Principal Investigator: | Nathalie COSTEDOAT-CHALUMEAU, MD, | Assistance Publique - Hôpitaux de Paris |
Study ID Numbers: | P051070 |
Study First Received: | December 18, 2006 |
Last Updated: | September 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00413361 |
Health Authority: | France: Ministry of Health |
Systemic Lupus Erythematosus Hydroxychloroquine |
Autoimmune Diseases Lupus Erythematosus, Systemic Hydroxychloroquine Connective Tissue Diseases |
Anti-Infective Agents Antimalarials Antiparasitic Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action |
Immune System Diseases Therapeutic Uses Enzyme Inhibitors Antirheumatic Agents Pharmacologic Actions |