ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 76 of 704 for:    lupus AND Lupus Erythematosus, Systemic

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

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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: prednisone discontinuation Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment (Prednisone 5 Milligram Per Day) in Quiescent Systemic Lupus
Study Start Date : January 2014
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus Steroids
Drug Information available for: Prednisone

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 Name: prednisone maintenance




Primary Outcome Measures :
  1. Occurence of mild or moderate flares of SLE defined by the SLE FLARE Index [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558517


Contacts
Contact: Zahir AMOURA, MD +33 1 42 17 80 01 zahir.amoura@aphp.fr
Contact: Fleur COHEN AUBART, PD, PhD +33 1 42 17 82 42 fleur.cohen@aphp.fr

Locations
France
Groupe Hospitalier Pitié Salpêtrière, Service de médecine Interne 2, Institut e3m Recruiting
Paris, France, 75 013
Contact: Zahir AMOURA, MD    +33 1 42 17 80 01    zahir.amoura@aphp.fr   
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
Investigators
Principal Investigator: Zahir AMOURA, MD Groupe Hospitalier Pitié Salpêtrière

Responsible Party: Dr Cohen Aubart, MD, PhD, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier: NCT02558517     History of Changes
Other Study ID Numbers: medint002
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016

Keywords provided by Dr Cohen Aubart, Groupe Hospitalier Pitie-Salpetriere:
Systemic Lupus Erythematosus
Corticosteroids
Chronic disease

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Prednisone
Hydroxychloroquine
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents