Just a moment, the page is loading...
Browse ALL STUDIES
Keyword Search
View All Selected
Clear All
Login / Create Account
Login
Create Account
Home
About Us
Privacy Policy
Minimum System Requirements
How To Join
Mission
Data Sponsors
Researchers
How It Works
How to Request Data
Review of Requests
Data Sharing Agreement
Access to Data
Independent Review Panel
Metrics
FAQs
News
Help/Contact Us
Examine the efficacy and safety of Belimumab in treatment of newly diagnosed Systemic Lupus Erythematosus in Chinese population
Proposal
11874
Title of Proposed Research
Examine the efficacy and safety of Belimumab in treatment of newly diagnosed Systemic Lupus Erythematosus in Chinese population
Lead Researcher
Xiaomei Leng
Affiliation
Peking Uion Medical College Hospital
Funding Source
Potential Conflicts of Interest
Data Sharing Agreement Date
06 April 2022
Lay Summary
Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease with multi-organ involvements and heterogeneous clinical manifestations, characterized by B cell hyperactivity and pathogenic autoantibodies formation. The loss of B cell tolerance and overactivation of T cells which result in excess production of autoantibodies are thought to be central in the role of pathogenesis of SLE. It is well accepted in the field that SLE disease duration is an important factor when predicting the responses to treatments. Based on our clinic experience, we discovered that patients with early disease responded better to Belimumab compared to those with longer disease duration. This discovery is consistent with a recent study from Italy indicating that early disease and low baseline organ damage were predictors of SRI-4 response. However, this discovery was observational based has not been well controlled and compared to standard of care (SOC). As mentioned in guidelines from different regions, early proper treatment has been promoted as a critical target in SLE management partially because it has been well known that early low disease activity or remission was associated with better prognosis. It is important to point out that the average disease duration of patients enrolled in the RCT studies was relatively long and none of them was stratified to examine the influence of disease duration on Belimumab efficacy and safety. Therefore, it is critical to conduct a study to examine and compare Belimumab to standard of care in SLE patients with early disease. However, the efficacy and safety of Belimumab has not been evaluated in Chinese SLE patients with short disease duration. This study aims to extract Chinese SLE patients with short disease duration and examine their response to the treatment of Belimumab. We hypothesize that SLE patients with early disease respond better to Belimumab plus SOC than SOC alone in achieving disease control.
Study Data Provided
[{ "PostingID": 19766, "Title": "GSK-BEL113750", "Description": "GSK1550188 A 52 week study of belimumab versus placebo in the treatment of subjects with systemic lupus erythematosus (SLE) located in Northeast Asia" }]
Statistical Analysis Plan
Publication Citation
© 2024 ideaPoint. All Rights Reserved.
Powered by ideaPoint.
Help
Privacy Policy
Cookie Policy
Help and Resources