Back to resultsEvaluation of the Discontinuation of Maintenance Corticosteroid Treatment in Quiescent Systemic Lupus (CORTICOLUP)
Primary Purpose
Systemic Lupus Erythematosus
Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
prednisone discontinuation
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Systemic Lupus Erythematosus, Corticosteroids, Chronic disease
Eligibility Criteria
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
Sites / Locations
- Groupe Hospitalier Pitié Salpêtrière, Service de médecine Interne 2, Institut e3mRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Prednisone maintenance
Prednisone discontinuation
Arm Description
Patients will be kept under Prednisone 5 milligrams/day. Other treatments will be maintained (in particular HYDROXYCHLOROQUINE, METHOTEXATE etc..)
Prednisone will be stopped and remplaced by HYDROCORTISONE for one month (20 mg/day). Other treatments will be maintained (in particular HYDROXYCHLOROQUINE, METHOTEXATE etc..)
Outcomes
Primary Outcome Measures
Occurence of mild or moderate flares of SLE defined by the SLE FLARE Index
Secondary Outcome Measures
Full Information
NCT ID
NCT02558517
First Posted
September 22, 2015
Last Updated
August 10, 2016
Sponsor
Groupe Hospitalier Pitie-Salpetriere
1. Study Identification
Unique Protocol Identification Number
NCT02558517
Brief Title
Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment in Quiescent Systemic Lupus
Acronym
CORTICOLUP
Official Title
Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment (Prednisone 5 Milligram Per Day) in Quiescent Systemic Lupus
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Groupe Hospitalier Pitie-Salpetriere
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Systemic Lupus Erythematosus, Corticosteroids, Chronic disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prednisone maintenance
Arm Type
No Intervention
Arm Description
Patients will be kept under Prednisone 5 milligrams/day. Other treatments will be maintained (in particular HYDROXYCHLOROQUINE, METHOTEXATE etc..)
Arm Title
Prednisone discontinuation
Arm Type
Experimental
Arm Description
Prednisone will be stopped and remplaced by HYDROCORTISONE for one month (20 mg/day). Other treatments will be maintained (in particular HYDROXYCHLOROQUINE, METHOTEXATE etc..)
Intervention Type
Drug
Intervention Name(s)
prednisone discontinuation
Other Intervention Name(s)
prednisone maintenance
Intervention Description
randomization
Primary Outcome Measure Information:
Title
Occurence of mild or moderate flares of SLE defined by the SLE FLARE Index
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zahir AMOURA, MD
Phone
+33 1 42 17 80 01
Email
zahir.amoura@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Fleur COHEN AUBART, PD, PhD
Phone
+33 1 42 17 82 42
Email
fleur.cohen@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zahir AMOURA, MD
Organizational Affiliation
Groupe Hospitalier Pitié-Salpêtrière
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Pitié Salpêtrière, Service de médecine Interne 2, Institut e3m
City
Paris
ZIP/Postal Code
75 013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zahir AMOURA, MD
Phone
+33 1 42 17 80 01
Email
zahir.amoura@aphp.fr
12. IPD Sharing Statement
Citations:
PubMed Identifier
31852672
Citation
Mathian A, Pha M, Haroche J, Cohen-Aubart F, Hie M, Pineton de Chambrun M, Boutin THD, Miyara M, Gorochov G, Yssel H, Cherin P, Devilliers H, Amoura Z. Withdrawal of low-dose prednisone in SLE patients with a clinically quiescent disease for more than 1 year: a randomised clinical trial. Ann Rheum Dis. 2020 Mar;79(3):339-346. doi: 10.1136/annrheumdis-2019-216303. Epub 2019 Dec 18.
Results Reference
derived
Learn more about this trial
Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment in Quiescent Systemic Lupus
We'll reach out to this number within 24 hrs