NCT02558517|UnknownPhase 3
Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment in Quiescent Systemic Lupus
CORTICOLUP
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CORTICOLUP
Sponsor study identifier
interventional
136
1 country
1
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
September 22, 2015
Actual (reported)September 24, 2015
Actual (reported)January 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Occurence of mild or moderate flares of SLE defined by the SLE FLARE Index
12 months
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..)
randomization
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Groupe Hospitalier Pitié Salpêtrière, Service de médecine Interne 2, Institut e3m
Paris, 75 013, France
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.
Zahir AMOURA, MD
Groupe Hospitalier Pitie-Salpetriere
First Submitted
September 22, 2015
First Posted
September 24, 2015
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2017
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 11, 2016
Record last verified: 2016-08
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Source: ClinicalTrials.gov.
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