Posted by Sarah Nocito on December 07, 2016
The COMBINE Study is now officially enrolling eligible patient participants. COMBINE is a research study looking to answer an important question: For kids with Crohn’s disease who need to start an anti-TNF medication (Remicade or Humira), does adding another medication called Methotrexate lead to better outcomes?
At present, it is not known if clinical outcomes (i.e., achievement of remission, treatment complications, quality of life) are best when pediatric Crohn’s disease is treated with an anti-TNF agent alone or in combination with methotrexate. COMBINE is the first trial to look at this question in children with Crohn’s disease. It is expected that 425 kids from across the US will enter the study. The results of this study will help doctors choose medications that help children the most. For more information about COMBINE, including a directory of enrolling centers, FAQ and Information Sheets, please visit http://combinetrial.org.
The University of North Carolina at Chapel Hill is sponsoring the study. This research study is partially funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (PCS-1406-18643). The study is also being supported by ImproveCareNow, an organization working to improve care, health and costs for all children and youth with Crohn’s disease and ulcerative colitis. Additional funding is provided by The Leona M. and Harry B. Helmsley Charitable Trust.
Parent partners who have children with Crohn’s disease are also part of the study team. Parent input for the COMBINE Study has been instrumental in making the study better for children and families.