Lead Investigator: Matthew Baker, Stanford University
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
Vivli Data Request: 5982
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
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.
Requested Studies:
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With ISN/RPS Class III or IV Lupus Nephritis (LUNAR)
Sponsor: Roche
Study ID: NCT00282347
Sponsor ID: U2970g
Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With Moderate to Severe Systemic Lupus Erythematosus (EXPLORER)
Sponsor: Roche
Study ID: NCT00137969
Sponsor ID: U2971g