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An Extension Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus (SLE) · Sponsor: Biogen
About this study
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. This is an extension study of 230LE303 and 230LE304 (TOPAZ-1 and TOPAZ-2). It will enroll participants who completed the treatment periods of either one of the parent studies. The main objective of the study is to learn more about the long-term safety of litifilimab. The main question researchers want to answer is: \- How many participants have adverse events and serious adverse events? Researchers will also learn about the effect litifilimab has on controlling symptoms of SLE and lowering its activity. They will measure symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the British Isles Lupus Activity Group-2004 (BILAG-2004), among others. Researchers will also study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires. The study will be done as follows: * The Week 52 visit of studies 230LE303 and 230LE304 will be Day 1 of this study. * Participants who were receiving either a…
This description comes directly from the study's public registry record.
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No contact information is available for this study as per the public registry record.
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Locations (197)
| Arizona Arthritis & Rheumatology Associates, P.C. | Phoenix, Arizona, United States | — |
| Wallace Rheumatic Study Center | Beverly Hills, California, United States | — |
| Care Access Research - Huntington Beach | Huntington Beach, California, United States | — |
| Providence Facey Medical Foundation | Mission Hills, California, United States | — |
| Inland Rheumatology Clinical Trials, Inc. | Upland, California, United States | — |
| University of Colorado Denver | Aurora, Colorado, United States | — |
| Georgetown University Hospital-Medstar | Washington D.C., District of Columbia, United States | — |
| Arthritis & Rheumatic Disease Specialties | Aventura, Florida, United States | — |
| Highlands Research Institute | Avon Park, Florida, United States | — |
| Clinical Research of West Florida - Corporate | Clearwater, Florida, United States | — |
| GNP Research at Mark Jaffe, MD | Cooper City, Florida, United States | — |
| Omega Research Consultants | DeBary, Florida, United States | — |
+ 185 more locations — full list on the registry record.
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