Status:
UNKNOWN
Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus
Lead Sponsor:
University of Pisa
Conditions:
Systemic Lupus Erythematosus
Glucocorticoids
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
This is a 36 months, randomized, double-blind, placebo-controlled, parallel-groups, equivalence multicenter trial in patients with inactive Systemic Lupus Erythematosus to evaluate if low disease acti...
Eligibility Criteria
Inclusion
- Diagnosis of SLE according to the EULAR/ACR criteria within three years from screening visit
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national subject privacy regulations
- Aged 18 to 75 years old, inclusive, at the time of informed consent
- Documented diagnosis of SLE according to the current ACR criteria
- Stable immunosuppressive treatment for SLE for a minimum of one year/six months
- Stable treatment with antimalarials for a minimum of 3 months
- stable (lasting for at least 6 months) low disease activity
Exclusion
- Disease activity (non LLDAS) within 6 months prior to screening
- Concomitant ongoing conditions (e.g. asthma, Crohn's disease) that require treatment with systemic GC (excluding topical or inhaled GC).
- Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, social) likely to affect the subject returning for follow-up visits on schedule
- Nursing mothers, pregnant women or women planning to become pregnant during the study.
Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT03804723
Start Date
June 1 2019
End Date
September 1 2023
Last Update
January 18 2019
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