Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus

NCT ID: NCT03804723

Last Updated: 2019-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 321 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-30
• Study Completion Date: 2023-09-30

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.

Conditions

Systemic Lupus Erythematosus; Glucocorticoids; Therapy Withdrawal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

GC withdrawal

Group Type: EXPERIMENTAL

oral Prednisone 5mg

Intervention Type: DRUG

patients randomized to this arm will stop prednisone 5 mg

non GC withdrawal

Group Type: PLACEBO_COMPARATOR

oral Prednisone 5mg

Intervention Type: DRUG

patients randomized to this arm will stop prednisone 5 mg

Interventions

oral Prednisone 5mg

patients randomized to this arm will stop prednisone 5 mg

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pisa

OTHER

Sponsor Role: lead

Responsible Party

Marta Mosca

Assistant Professor of Rheumatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Marta Mosca, MD

Role: CONTACT

marta.mosca@med.inipi.it

050992519

Chiara Tani, MD

Role: CONTACT

chiara.tani@ao-pisa.toscana.it

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id