A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Crohn's Disease
In brief
The purpose of this study is to assess long-term safety data of GED-0301 for a period of up to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3 GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will receive active treatment, this study is double-blinded for the entire 208 weeks for the purpose of preserving the blind of the subject's treatment allocation in the initial, core Phase 3 GED-0301 study. The GED-0301-CD-003 trial was not initiated; see detailed description.
Key facts
- Study ID
- NCT02641392
- Run by
- Celgene
- People needed
- 310
- Starts
- 2016-07-25
- Expected to finish
- 2018-01-04
- Last updated by the study team
- 2019-01-29
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Atlanta Gastroenterology Associates, LLC — Atlanta, Georgia, United States
- Indiana University — Indianapolis, Indiana, United States
- Health Science Research Center, LLC — Pratt, Kansas, United States
- Via Christi Research a division of Via Christi Hospitals Wichita Inc — Wichita, Kansas, United States
- Gastroenterology Associates LLC — Baton Rouge, Louisiana, United States
- Metropolitan Gastroenterology — Chevy Chase, Maryland, United States
- Clinical Research Institute of Michigan, LLC — Chesterfield, Michigan, United States
- Gastroenterology Associates of Western Michigan PLC — Wyoming, Michigan, United States
- Ehrhardt Clinical Research LLC — Belton, Missouri, United States
- Columbia University Medical Center — New York, New York, United States
- Trial Management Associates LLC — Wilmington, North Carolina, United States
- ClinSearch LLC — Chattanooga, Tennessee, United States
- Texas Clinical Research Institute LLC — Arlington, Texas, United States
- Texas Digestive Disease Consultants - Dallas — Dallas, Texas, United States
- Texas Digestive Disease Consultants - Southlake — Flower Mound, Texas, United States
- University of Texas Health Science Center at Houston — Houston, Texas, United States
- Sagact Pllc — San Antonio, Texas, United States
- San Antonio Military Medical Center — San Antonio, Texas, United States
- Digestive Health Specialists of Tyler — Tyler, Texas, United States
- Virginia Mason Medical Center — Seattle, Washington, United States
- University of Washington School of Medicine — Seattle, Washington, United States
- The Vancouver Clinic — Vancouver, Washington, United States
- Concord Repatriation General Hospital — Concord, New South Wales, Australia
- Centre For Digestive Diseases — Five Dock, New South Wales, Australia
- Medical Associates Research Group Inc. — San Diego, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.