Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Systemic Lupus Erythematosus; Glucocorticoids; Therapy Withdrawal
• Intervention / Treatment: Drug: oral Prednisone 5mg

• Study Type: Interventional
• Enrollment (Anticipated): 321
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marta Mosca, MD; Phone Number: 050992519; Email: marta.mosca@med.inipi.it
• Study Contact Backup: Name: Chiara Tani, MD; Email: chiara.tani@ao-pisa.toscana.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GC withdrawal	Drug: oral Prednisone 5mg; patients randomized to this arm will stop prednisone 5 mg
Placebo Comparator: non GC withdrawal	Drug: oral Prednisone 5mg; patients randomized to this arm will stop prednisone 5 mg

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pisa

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2019
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: January 11, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2019
• Last Update Submitted That Met QC Criteria: January 16, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisone
• Other Study ID Numbers: 001 (NavyGHB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No