Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03804723
• Other study ID #: 001
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2019
• Est. completion date: September 2023

Study information

• Verified date: January 2019
• Source: University of Pisa
• Contact: Marta Mosca, MD
• Phone: 050992519
• Email: marta.mosca[@]med.inipi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 321
• Est. completion date: September 2023
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucocorticoids
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus
• Therapy Withdrawal

Intervention

Drug:
• oral Prednisone 5mg
patients randomized to this arm will stop prednisone 5 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pisa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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