Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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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.

Official Title
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Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus: a Randomized Placebo-controlled Equivalence Trial

Conditions
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Systemic Lupus Erythematosus, Glucocorticoids, Therapy Withdrawal

Intervention / Treatment
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* Drug: oral Prednisone 5mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a 36 month, randomized, double-blind, placebo-controlled, parallel-groups, equivalence multicenter trial in patients with inactive SLE to evaluate if low disease activity can be sustained with withdrawal of glucocorticoids
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GC withdrawal<br> | Drug: oral Prednisone 5mg<br>* patients randomized to this arm will stop prednisone 5 mg<br>|
| Placebo Comparator: non GC withdrawal<br> | Drug: oral Prednisone 5mg<br>* patients randomized to this arm will stop prednisone 5 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease flare | 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. | 35 months |