Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus

Not Applicable

• Conditions: Systemic Lupus Erythematosus; Glucocorticoids; Therapy Withdrawal
• Interventions: Drug: oral Prednisone 5mg

• Registration Number: NCT03804723
• Lead Sponsor: University of Pisa

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 activity can be sustained with withdrawal of glucocorticoids in patients on stable clinical remission or low disease activity.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-11
• Study First Submitted QC: 2019-01-11
• Study First Posted: 2019-01-15
• Last Update Submitted: 2019-01-16
• Last Update Posted: 2019-01-18
• Study Start: 2019-06
• Primary Completion: 2022-06
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 321

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GC withdrawal	oral Prednisone 5mg	-
non GC withdrawal	oral Prednisone 5mg	-

Primary Outcome Measures

Name	Time	Method
disease flare	35 months	The primary endpoint is the proportion of patients who will experience a disease during the follow-up period in the groups given prednisone 5 mg or placebo in the double-blind period.