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Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment in Quiescent Systemic Lupus (CORTICOLUP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02558517
Recruitment Status : Unknown
Verified August 2016 by Dr Cohen Aubart, Groupe Hospitalier Pitie-Salpetriere.
Recruitment status was:  Recruiting
First Posted : September 24, 2015
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):
Dr Cohen Aubart, Groupe Hospitalier Pitie-Salpetriere

Tracking Information
First Submitted Date  ICMJE September 22, 2015
First Posted Date  ICMJE September 24, 2015
Last Update Posted Date August 11, 2016
Study Start Date  ICMJE January 2014
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2015)
Occurence of mild or moderate flares of SLE defined by the SLE FLARE Index [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment in Quiescent Systemic Lupus
Official Title  ICMJE Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment (Prednisone 5 Milligram Per Day) in Quiescent Systemic Lupus
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE Drug: prednisone discontinuation
randomization
Other Name: prednisone maintenance
Study Arms  ICMJE
  • No Intervention: Prednisone maintenance
    Patients will be kept under Prednisone 5 milligrams/day. Other treatments will be maintained (in particular HYDROXYCHLOROQUINE, METHOTEXATE etc..)
  • Experimental: Prednisone discontinuation
    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: Drug: prednisone discontinuation
Publications * Mathian A, Pha M, Haroche J, Cohen-Aubart F, Hié 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 23, 2015)
136
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2018
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02558517
Other Study ID Numbers  ICMJE medint002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Cohen Aubart, Groupe Hospitalier Pitie-Salpetriere
Study Sponsor  ICMJE Groupe Hospitalier Pitie-Salpetriere
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zahir AMOURA, MD Groupe Hospitalier Pitié-Salpêtrière
PRS Account Groupe Hospitalier Pitie-Salpetriere
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP