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

Systemic Lupus Erythematosus Clinical Trial

— CORTICOLUP  

Official title:

Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment (Prednisone 5 Milligram Per Day) in Quiescent Systemic Lupus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02558517
• Other study ID #: medint002
• Status: Recruiting
• Phase: Phase 3
• First received: September 22, 2015
• Last updated: August 10, 2016
• Start date: January 2014
• Est. completion date: January 2018

Study information

• Verified date: August 2016
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: Zahir AMOURA, MD
• Phone: +33 1 42 17 80 01
• Email: zahir.amoura[@]aphp.fr
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: January 2018
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• prednisone discontinuation
randomization

Locations

Country	Name	City	State
France	Groupe Hospitalier Pitié Salpêtrière, Service de médecine Interne 2, Institut e3m	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of mild or moderate flares of SLE defined by the SLE FLARE Index		12 months	No