Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment in Quiescent Systemic Lupus
- Registration Number
- NCT02558517
- Lead Sponsor
- Groupe Hospitalier Pitie-Salpetriere
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 136
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prednisone discontinuation prednisone discontinuation Prednisone will be stopped and remplaced by HYDROCORTISONE for one month (20 mg/day). Other treatments will be maintained (in particular HYDROXYCHLOROQUINE, METHOTEXATE etc..)
- Primary Outcome Measures
Name Time Method Occurence of mild or moderate flares of SLE defined by the SLE FLARE Index 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Groupe Hospitalier Pitié Salpêtrière, Service de médecine Interne 2, Institut e3m
🇫🇷Paris, France