Corrona Registries: Inflammatory Bowel Disease
Corrona launched an Inflammatory Bowel Disease Registry in May 2017.
The primary objective of the registry is to study comparative safety of IBD treatments. Secondary objectives include analyzing the epidemiology and natural history of Inflammatory Bowel Disease, comorbidities, prescribing practices, and comparative effectiveness.
The Corrona™ IBD Registry is enrolling patients diagnosed with Crohn's, Ulcerative Colitis, or Indeterminate Colitis by a gastroenterologist. Data is collected from both patients and their treating gastroenterologist at regular outpatient office visits.
In general, clinical trials provide safety data on new treatments for 6 to 12 months, but the long-term safety profiles of agents remain unclear. As new drugs are approved for both Crohn's and Ulcerative Colitis patients, there is a growing need for an independent registry that will collect long-term real world data on safety, comorbidities, and quality of life.
- Led by our Scientific Advisory Group headed by Dr. Josh Korzenik, Brigham and Women's Hospital.
- Prospective, multicenter, observational disease-based registry.
- SAEs and AEs of special interest collected (MACE, malignancies, infection, etc).
- Data collection from both treating gastroenterologists and patient at routine outpatient visits.
- ~50 U.S. gastroenterology sites planned; enrollment of 3-5,000 IBD patients. First Patient in (FPI) achieved May 03, 2017.
- Payment for baseline and follow-up visits.