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

August 10, 2016 updated by: Dr Cohen Aubart, Groupe Hospitalier Pitie-Salpetriere

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

136

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75 013
        • Recruiting
        • Groupe Hospitalier Pitié Salpêtrière, Service de médecine Interne 2, Institut e3m
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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..)
Drug: prednisone discontinuation
randomization
Other Names:
  • prednisone maintenance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurence of mild or moderate flares of SLE defined by the SLE FLARE Index
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Pitie-Salpetriere

Investigators

  • Principal Investigator: Zahir AMOURA, MD, Groupe Hospitalier Pitie-Salpetriere

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

September 22, 2015

First Submitted That Met QC Criteria

September 23, 2015

First Posted (Estimate)

September 24, 2015

Study Record Updates

Last Update Posted (Estimate)

August 11, 2016

Last Update Submitted That Met QC Criteria

August 10, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • medint002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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