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Investigating the effects of rituximab on specific cell subsets and cytokine levels in systemic lupus erythematosus patients and constructing a prediction model of treatment response
Proposal
5625
Title of Proposed Research
Investigating the effects of rituximab on specific cell subsets and cytokine levels in systemic lupus erythematosus patients and constructing a prediction model of treatment response
Lead Researcher
Matthew Baker
Affiliation
Stanford University
Funding Source
Potential Conflicts of Interest
Data Sharing Agreement Date
5 Mar 2019
Lay Summary
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that primarily affects women of child-bearing age and can be life threatening. Currently, many patients are unable to attain adequate disease control with existing treatments. Numerous attempts have been made to develop more effective therapies for SLE, however most trials have failed. This is in part due to the complexity of the disease, which makes it hard to select appropriate patients for a trial, and due to the use of preexisting medications during the trial, which can mask the benefit of a new treatment. In 2010 and 2012, two clinical trials were conducted using a drug called rituximab, which depletes a specific immune cell in the body known as the B cell. These cells are responsible for making antibodies, which normally protect the body against foreign invaders such as bacteria and viruses, however in SLE patients, these antibodies attack the person's own tissues. Thus, it makes rational sense that eliminating these cells could improve disease activity. Neither trial was successful, however, likely due to the aforementioned issues. However, a number of interesting labs were performed before and after treatment, and most have never been analyzed. This project proposes to examine the effects of rituximab on different immune cell subsets and cytokines (messenger molecules that can lead to inflammation). By understanding how these parameters change in patients who respond to rituximab compared to those who do not respond, it may provide key insights into how rituximab works and allow us to predict patients who are more likely to respond to rituximab in the future.
Study Data Provided
[{ "PostingID": 3680, "Title": "ROCHE-U2970G", "Description": "A Phase III, Randomized, Double-Blind Placebo Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Class III, IV Lupus Nephritis" },{ "PostingID": 3681, "Title": "ROCHE-U2971G", "Description": "A Phase II/III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Non-Renal Systemic Lupus Erythematosis" }]
Statistical Analysis Plan
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