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| Name | Class |
|---|---|
| Sanofi-Synthelabo | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator | placebo |
|
| B | Experimental | versus hydroxychloroquine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| versus hydroxychloroquine | Drug | versus hydroxychloroquine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 months of follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 months of follow up |
| The total number of flares in each group |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Nathalie COSTEDOAT-CHALUMEAU, MD, | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Pitie Salpetriere | Paris | 75013 | France | |||
| Hopital la Pitié Salpétrière Assistance Publique |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27399966 | Derived | Morris DL, Sheng Y, Zhang Y, Wang YF, Zhu Z, Tombleson P, Chen L, Cunninghame Graham DS, Bentham J, Roberts AL, Chen R, Zuo X, Wang T, Wen L, Yang C, Liu L, Yang L, Li F, Huang Y, Yin X, Yang S, Ronnblom L, Furnrohr BG, Voll RE, Schett G, Costedoat-Chalumeau N, Gaffney PM, Lau YL, Zhang X, Yang W, Cui Y, Vyse TJ. Genome-wide association meta-analysis in Chinese and European individuals identifies ten new loci associated with systemic lupus erythematosus. Nat Genet. 2016 Aug;48(8):940-946. doi: 10.1038/ng.3603. Epub 2016 Jul 11. | |
| 25379192 |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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The total number of flares in each group
| 7 months of follow up |
| the total dose of steroids in each group | the total dose of steroids in each group | 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 | 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 | 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 | 7 months of follow up |
| Treatment tolerance evaluation will include clinical, electrocardiographic and ophthalmologic screening. | Treatment tolerance evaluation will include clinical, electrocardiographic and ophthalmologic screening. | 7 months of follow up |
| Paris |
| 75013 |
| France |
| Derived |
| Schoindre Y, Jallouli M, Tanguy ML, Ghillani P, Galicier L, Aumaitre O, Frances C, Le Guern V, Liote F, Smail A, Limal N, Perard L, Desmurs-Clavel H, Le Thi Huong D, Asli B, Kahn JE, Sailler L, Ackermann F, Papo T, Sacre K, Fain O, Stirnemann J, Cacoub P, Leroux G, Cohen-Bittan J, Hulot JS, Lechat P, Musset L, Piette JC, Amoura Z, Souberbielle JC, Costedoat-Chalumeau N; Group PLUS. Lower vitamin D levels are associated with higher systemic lupus erythematosus activity, but not predictive of disease flare-up. Lupus Sci Med. 2014 Jun 7;1(1):e000027. doi: 10.1136/lupus-2014-000027. eCollection 2014. |
| 23833039 | Derived | Morel N, Bachelot A, Chakhtoura Z, Ghillani-Dalbin P, Amoura Z, Galicier L, Aumaitre O, Piette JC, Pourrat J, Boutin D, Sacre K, Kahn JE, Duhaut P, Farge D, Frances C, Guettrot-Imbert G, Harle JR, Lambotte O, Le Guern V, Sene D, Trad S, Vidal E, Sarrot-Reynauld F, Gompel A, Tanguy ML, Touraine P, Lacorte JM, Costedoat-Chalumeau N; PLUS group. Study of anti-Mullerian hormone and its relation to the subsequent probability of pregnancy in 112 patients with systemic lupus erythematosus, exposed or not to cyclophosphamide. J Clin Endocrinol Metab. 2013 Sep;98(9):3785-92. doi: 10.1210/jc.2013-1235. Epub 2013 Jul 5. |
| 23144449 | Derived | Costedoat-Chalumeau N, Galicier L, Aumaitre O, Frances C, Le Guern V, Liote F, Smail A, Limal N, Perard L, Desmurs-Clavel H, Boutin du LT, Asli B, Kahn JE, Pourrat J, Sailler L, Ackermann F, Papo T, Sacre K, Fain O, Stirnemann J, Cacoub P, Jallouli M, Leroux G, Cohen-Bittan J, Tanguy ML, Hulot JS, Lechat P, Musset L, Amoura Z, Piette JC; Group PLUS. Hydroxychloroquine in systemic lupus erythematosus: results of a French multicentre controlled trial (PLUS Study). Ann Rheum Dis. 2013 Nov;72(11):1786-92. doi: 10.1136/annrheumdis-2012-202322. Epub 2012 Nov 10. |