Systemic Lupus Erythematosus
Conditions
Keywords
Systemic Lupus Erythematosus, Corticosteroids, Chronic disease
Brief summary
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.
Interventions
DRUGprednisone discontinuation
randomization
Sponsors
Groupe Hospitalier Pitie-Salpetriere
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with SLE according to the ACR revised criteria. * Quiescent disease without flare since at least one year (SELENA SLEDAI \< or equal to 4, BILAG C, D or E, PGA 0) \_ Treatment with 5 milligrams/day of prednisone since at least 1 year
Exclusion criteria
* failure to sign the informed consent or unable to consent * Patient participating to another clinical trial * Pregnancy or plan to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurence of mild or moderate flares of SLE defined by the SLE FLARE Index | 12 months |
Countries
France
Contacts
Primary ContactZahir AMOURA, MD
Backup ContactFleur COHEN AUBART, PD, PhD
Outcome results
None listed