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Systemic Lupus (SLE) is a chronic disease for which long term treatments are warranted. The aim of this study was to study the possibility of corticosteroids interruption in patients with quiescent SLE treated since at least one year with 5 milligrams of predonisone per day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisone maintenance | No Intervention | Patients will be kept under Prednisone 5 milligrams/day. Other treatments will be maintained (in particular HYDROXYCHLOROQUINE, METHOTEXATE etc..) | |
| Prednisone discontinuation | Experimental | Prednisone will be stopped and remplaced by HYDROCORTISONE for one month (20 mg/day). Other treatments will be maintained (in particular HYDROXYCHLOROQUINE, METHOTEXATE etc..) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prednisone discontinuation | Drug | randomization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of mild or moderate flares of SLE defined by the SLE FLARE Index | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zahir AMOURA, MD | Contact | +33 1 42 17 80 01 | zahir.amoura@aphp.fr | |
| Fleur COHEN AUBART, PD, PhD | Contact | +33 1 42 17 82 42 | fleur.cohen@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Zahir AMOURA, MD | Groupe Hospitalier Pitie-Salpetriere | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier Pitié Salpêtrière, Service de médecine Interne 2, Institut e3m | Recruiting | Paris | 75 013 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31852672 | Derived | Mathian A, Pha M, Haroche J, Cohen-Aubart F, Hie M, Pineton de Chambrun M, Boutin THD, Miyara M, Gorochov G, Yssel H, Cherin P, Devilliers H, Amoura Z. Withdrawal of low-dose prednisone in SLE patients with a clinically quiescent disease for more than 1 year: a randomised clinical trial. Ann Rheum Dis. 2020 Mar;79(3):339-346. doi: 10.1136/annrheumdis-2019-216303. Epub 2019 Dec 18. |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |