Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus

University of Pisa

Status

Unknown

Conditions

Therapy Withdrawal

Glucocorticoids

Systemic Lupus Erythematosus

Treatments

Drug: oral Prednisone 5mg

Study type

Interventional

Funder types

Other

Identifiers

NCT03804723

001

Details and patient eligibility

About

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.

Enrollment

321 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.