Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment in Quiescent Systemic Lupus
NCT ID: NCT02558517
Last Updated: 2016-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
136 participants
INTERVENTIONAL
2014-01-31
2018-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Weaning of Immunosuppression in Nephritis of Lupus
NCT01284725
Personalised Pharmacological Approach to the Tapering of Corticosteroid Doses in Systemic Lupus Patients Treated With Prednisone
NCT03187743
Steroids in the Maintenance of Remission of Proliferative Lupus Nephritis
NCT00539799
Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus
NCT03804723
Gradual Withdrawal of Low-dose Glucocorticoid in Clinically Quiescent Systemic Lupus Erythematosus.
NCT06234852
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Prednisone maintenance
Patients will be kept under Prednisone 5 milligrams/day. Other treatments will be maintained (in particular HYDROXYCHLOROQUINE, METHOTEXATE etc..)
No interventions assigned to this group
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..)
prednisone discontinuation
randomization
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
prednisone discontinuation
randomization
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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
* Patient participating to another clinical trial
* Pregnancy or plan to become pregnant
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Groupe Hospitalier Pitie-Salpetriere
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr Cohen Aubart
MD, PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zahir AMOURA, MD
Role: PRINCIPAL_INVESTIGATOR
Groupe Hospitalier Pitié-Salpêtrière
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Groupe Hospitalier Pitié Salpêtrière, Service de médecine Interne 2, Institut e3m
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
medint002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.