Ignite Creation Date:
2024-05-06 @ 8:53 AM
Last Modification Date:
2024-10-26 @ 12:06 PM
Study NCT ID:
NCT02842814
Status:
COMPLETED
Last Update Posted:
2022-10-03
First Post:
2016-06-03
Brief Title:
Prediction of Relapse Risk in Stable Systemic Lupus Erythematosus
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Evaluation and Prediction of Relapse Risk After Glucocorticoid Withdrawal in Patients With Stable Systemic Lupus Erythematosus An Open-labeled Multi-centric Randomized Controlled Study From China
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRESS
Brief Summary:
Whether and when systemic lupus erythematosus SLE patients with stable disease should withdraw glucocorticoid GC How about the relapse risk What are the risk factors for disease flare All the above are unclear Long-course GC treatment has a lot of side-effects even in a sustaining low dose The aim of this study is to explore the relapse risk after GC withdrawal in SLE patients with stable disease more than one year and to establish a predictive model for flare risk stratification
Detailed Description:
Systemic lupus erythematosus SLE is a chronic autoimmune disease with a relapsing-remitting course For patients in remission glucocorticoid GC is used to be maintained in a low dose for a long time in fear of disease flare Long-term GC could bring a lot of side-effects even in a low dose Whether and when patients with stable disease should withdraw GC How about the relapse risk What are the risk factors for disease flare All the above remain unclear The aim of this study is to explore the relapse risk after GC withdrawal in SLE patients with stable disease and to establish a predictive model for risk stratification Meanwhile the investigators aim to testify the effects of hydroxychloroquine in preventing SLE relapse This study is an open-labeled randomized controlled clinical trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None