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IPF-PRO Registry will expand to target 1,500 patients at approximately 45 clinical sites nationwide
Real-world data from large, geographically diverse IPF patient group will help advance understanding of disease progression and patient-reported outcomes
RIDGEFIELD, C.T. and DURHAM, N.C. - Boehringer Ingelheim Pharmaceuticals, Inc. and the Duke Clinical Research Institute (DCRI) announced today the expansion of the Idiopathic Pulmonary Fibrosis – PROspective Outcomes (IPF-PRO) Registry, a patient registry developed to uncover insights into IPF, a rare and serious lung disease. The expansion will increase the study enrollment from 300 patients at 18 study sites to 1,500 patients at approximately 45 sites, creating the largest registry of newly diagnosed IPF patients.
The IPF-PRO Registry, which was launched in June 2014, was the first multi-center longitudinal disease state registry in the United States focused specifically on IPF. Boehringer Ingelheim and the DCRI have agreed to expand the IPF-PRO Registry based on the quality of the data and insights obtained from the first 300 patients enrolled in the registry and the growing scientific need for diverse, real-world data to understand IPF disease progression, disease history, patient-reported outcomes and disease biomarkers.
"Expanding the IPF-PRO Registry is important to the IPF community because it will substantially advance the understanding of this rare and fatal lung disease," said Scott Palmer, M.D., director of Pulmonary Research at the DCRI. "In collecting data from a larger, more diverse group of patients from multiple centers nationwide – all of whom are newly diagnosed with IPF – this registry will allow us to better assess the impact of the disease over time on clinical and patient centered outcomes."
One element of the IPF-PRO Registry is a bio-repository that stores blood samples that provide patient genetic material that may help to better understand the relationship of various biomarkers to patient outcomes. The Registry expansion will substantially increase the size of the bio-repository, creating additional opportunities for future translational research and the identification of novel biomarkers that may be predictive of disease outcomes or individual patient treatment responses.
"The IPF-PRO Registry, which represents a valuable academic-industry partnership, is a substantial and important opportunity for Boehringer Ingelheim to contribute to the advancement of our understanding of IPF – independent of any particular medication or drug discovery effort," said Craig Conoscenti, M.D., Principal Expert, Clinical Development and Medical Affairs and Interstitial Lung Disease Program Lead, at Boehringer Ingelheim Pharmaceuticals, Inc. "We are proud to continue our collaborative partnership with the Duke Clinical Research Institute, as we bring our unique strengths and expertise together in working toward improving the lives of those living with IPF."
The centers that have been part of this successful registry to date include:
IPF is a rare and serious lung disease that causes permanent scarring of the lungs. It affects as many as 132,000 Americans, typically men over the age of 65. Early diagnosis and proper care are critical to helping people treat their condition.
The Idiopathic Pulmonary Fibrosis – PROspective Outcomes (IPF-PRO) Registry is a prospective, multi-center study designed to better understand the natural progression of, and treatment approaches to, idiopathic pulmonary fibrosis (IPF). IPF-PRO is a unique collaboration between Boehringer Ingelheim and the Duke Clinical Research Institute designed to build on the knowledge from single-center studies and clinical trials.
The primary measures include: characterizing and describing the natural history of newly-diagnosed patients; understanding current practice patterns; and describing the impact of IPF on patient quality-of-life. The registry also will include a biomarker bank to identify potential blood or genetic markers of the disease that correlate with patient outcomes.
For more information, please visit clinicaltrials.gov/ct2/show/NCT01915511.
About the Duke Clinical Research Institute
The Duke Clinical Research Institute (DCRI), part of the Duke University School of Medicine, is the largest academic research organization in the world. Its mission is to develop and share knowledge that improves the care of patients through innovative clinical research. The DCRI conducts groundbreaking multinational clinical trials, manages major national patient registries, and performs landmark outcomes research. DCRI research spans multiple disciplines, from pediatrics to geriatrics, primary care to subspecialty medicine, and genomics to proteomics. The DCRI also is home to the Duke Databank for Cardiovascular Diseases, the largest and oldest institutional cardiovascular database in the world, which continues to inform clinical decision-making more than 40 years after its founding.
About Boehringer Ingelheim
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.
Boehringer Ingelheim is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 145 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.
Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. Our employees create and engage in programs that strengthen our communities. To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.
In 2015, Boehringer Ingelheim achieved net sales of about $15.8 billion (14.8 billion euros). R&D expenditure corresponds to 20.3 percent of its net sales.
For more information please visit www.us.boehringer-ingelheim.com, or follow us on Twitter @BoehringerUS.