Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus

NCT03804723 | Unknown

• 1 other identifier: 001
• Study Type: interventional
• Target: 321
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

GC withdrawal

EXPERIMENTAL

Drug: oral Prednisone 5mg

non GC withdrawal

PLACEBO COMPARATOR

Drug: oral Prednisone 5mg

Interventions

oral Prednisone 5mg DRUG

patients randomized to this arm will stop prednisone 5 mg

GC withdrawal; non GC withdrawal

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pisa: lead

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Marta Mosca, MD

CONTACT

050992519; marta.mosca@med.inipi.it

Chiara Tani, MD

CONTACT

chiara.tani@ao-pisa.toscana.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Rheumatology

Model Details: 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

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 15, 2019
• Study Start: June 1, 2019
• Primary Completion: June 1, 2022
• Study Completion: September 1, 2023
• Last Updated: January 18, 2019

Record last verified: 2019-01