Boehringer Ingelheim Pharmaceuticals and the Duke Clinical Research Institute (DCRI) are expanding the Idiopathic Pulmonary Fibrosis PROspective Outcomes Registry (IPF-PRO), which they say will make it the largest IPF patient registry in the country. The plan will increase the enrollment from 300 patients at 18 study sites to 1,500 patients at 45 sites.
The IPF-PRO was first launched in June 2014 as the first multi-center longitudinal disease state registry in the U.S. created to gain new insights into idiopathic pulmonary fibrosis (IPF).
The IPF-PRO Registry (NCT01915511) is designed to increase understanding of the progression of IPF and help lead treatment approaches to the disease. Primary measures of the study include characterizing the natural history of newly diagnosed patients; analyzing current practice patterns; and characterizing the impact of IPF on patients’ quality of life.
The registry will also have a biomarker bank to help identify potential genetic or blood biomarkers that correlate with patients’ outcomes.
“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,” Dr. Craig Conoscenti, MD, principal expert of clinical development and medical affairs and interstitial lung disease program lead at Boehringer, said in a press release.
“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,” he said.
The industry and research collaborators agreed to expand the registry based on the quality of the data and insights obtained from the first 300 patients, and the growing scientific need for heterogeneous, real-world data to understand IPF progression, history, patient-reported outcomes, and 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 Dr. Scott Palmer, MD, director of pulmonary research at DCRI, which is part of Duke University School of Medicine in Durham, North Carolina.
“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.”