Your clinician has asked you to consider having your child join a research study named COMBINE, therefore, you will want to know what this study is about. Below is some basic information to tell you more about COMBINE. At the bottom is a list of links, including the COMBINE website, where you will find much more detailed information.
What is the COMBINE Study?
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?
Pediatric Crohn’s disease experts are split on whether adding Methotrexate to anti-TNF treatment is better or not.
Some experts think that two medications for Crohn’s disease may work better.
Other experts think that two medications may not work better than one and could add side effects.
Why is the COMBINE Study important?
COMBINE is the first study 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.
What is Anti-TNF medication?
Tumor Necrosis Factor, or TNF for short, is a chemical made by some immune cells in the body. Medications that block TNF have been found to be effective in treating Crohn’s disease in adults and kids. These medications are also called Biologics. Examples include infliximab (Remicade) and adalimumab (Humira).
To be eligible to participate in COMBINE your child will have to be starting an anti-TNF medication on the recommendation of your clinician.
What is Methotrexate?
Methotrexate is a medication that interferes with the vitamin folic acid inside of cells and is an immunomodulator – meaning it can have effects on the immune system. Methotrexate has been used in both adults and kids to treat Crohn’s and a number of other diseases. It comes as a pill or a shot. People taking Methotrexate also take folic acid to protect healthy cells and prevent any side effects of the medication.
If my child joins COMBINE, what happens?
Your child will be randomly assigned to one of two study groups. In one of the groups, the pill form of Methotrexate will be added to children’s anti-TNF therapy. In the other group, children will receive a look-alike but inactive placebo pill along with their anti-TNF therapy. During the study neither your doctors, the researchers, your child, nor you will know which group your child is in.
COMBINE is designed to rely on information collected at your routine clinic visits with your Crohn’s specialist. The results of examinations, blood work, and tests obtained by your clinic as part of routine care during these visits will be included in a research database that the study team will use. There will also be some phone calls from study staff to make sure you receive your medications and to check with you on how things are going once treatment has started.
Your child’s health will be monitored by your doctors. If during the study there is a concern about your child’s Crohn’s disease progressing or a major problem that could be a side effect of the study medication, your clinic can request to be told whether you are receiving methotrexate or inactive placebo.
Who is conducting the COMBINE Study?
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, Grifols Diagnostics Solutions Inc. and the National Institutes of Health.
How do I learn more?
Visit the COMBINE website (combinetrial.org) for detailed information about the study and research in general, including more frequently asked questions, videos and testimonials from parents.
Visit the PCORI website to read the Project Summary for the COMBINE study
Visit the ImproveCareNow website (www.improvecarenow.org) for study announcements.