Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment in Quiescent Systemic Lupus

Groupe Hospitalier Pitie-Salpetriere136 enrolled

Overview

Systemic Lupus (SLE) is a chronic disease for which long term treatments are warranted. The aim of this study was to study the possibility of corticosteroids interruption in patients with quiescent SLE treated since at least one year with 5 milligrams of predonisone per day.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

136

Conditions

Systemic Lupus Erythematosus

Interventions

prednisone discontinuationDRUG

randomization

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with SLE according to the ACR revised criteria. * Quiescent disease without flare since at least one year (SELENA SLEDAI \< or equal to 4, BILAG C, D or E, PGA 0) \_ Treatment with 5 milligrams/day of prednisone since at least 1 year Exclusion Criteria: * failure to sign the informed consent or unable to consent * Patient participating to another clinical trial * Pregnancy or plan to become pregnant

Locations (1)

Groupe Hospitalier Pitié Salpêtrière, Service de médecine Interne 2, Institut e3m

Paris, France

RECRUITING

Outcomes

Primary Outcomes

Occurence of mild or moderate flares of SLE defined by the SLE FLARE Index

Time frame: 12 months

Central Contacts

Zahir AMOURA, MD

CONTACT

+33 1 42 17 80 01 zahir.amoura@aphp.fr

Fleur COHEN AUBART, PD, PhD

CONTACT

+33 1 42 17 82 42 fleur.cohen@aphp.fr

Data from ClinicalTrials.gov

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