Clinical Trials in the North Texas Area
LFA's Center for Clinical Trials Education (CCTE)
Spotlight on: the EMBODY program
Study Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects with Moderate to Severe Disease.
Sponsor: UCB, Inc.
Purpose: To confirm the clinical efficacy of epratuzumab in the treatment of subject with Systemic Lupus Erythematosus (SLE)
Eligibility Criteria: Men and women, at least 18 years old
Major gaps exist in the understanding of the causes and consequences of lupus. To address these gaps, it is essential that both the public and private sectors greatly increase their investments in medical research on lupus. This research will lead to the discovery of new, less toxic, safe and effective medications for lupus and, eventually, a cure. There also is an urgent need to translate emerging research findings into understandable messages for those at highest risk for the disease, as well as for their caregivers and physicians, to ensure earlier diagnosis and treatment that can save lives.
- Influences additional congressional appropriations to provide new funding for lupus research, including the U.S. Department of Defence (DOD) to validate lupus biomarkers, and through the Centers for Disease Control and Prevention (CDC) to support data collection to determine the incidence and prevalence of lupus
- Supports national research efforts to nine research sites for the study and validation of lupus biomarkers
- Expands LFA's Five-Year Research Program to support studies on the prevention of heart and blood vessel disease in women with lupus
- Conducts a scientific meeting to discuss parameters for a model national-scale epidemiological study on lupus
- Collaborates with biotechnology and pharmaceutical companies to recruit participants for clinical trials designed to test potential new lupus medications
- Served as the sole nonprofit sponsor of a conference on Lupus and the Environment conducted by the National Institute of Environmental Health Sciences (NIEHS)
- Increases public and private sector funding of lupus research
- Educates physicians and other health professionals about the latest scientific findings on lupus