Posted by Steven Steiner on November 02, 2015
“A journey of a thousand miles begins with a single step” – Chinese philosopher Laozi, 6th century BC
With great admiration, I have been witness to the strides that ImproveCareNow (ICN) has been making in our research efforts. As co-chair of the Research Committee, I am able to observe all of the wonderful ideas that the community puts forth for consideration. As with any learning curve, every step is not smooth, and we occasionally stumble and fall. Our colleagues are next to us ready to offer a helping hand though.
We are about to begin an incredible research journey in the ICN community, and we are lucky to have Dr. Mike Kappelman as our guide. In April, Mike was the recipient of $7.9 million in Patient Centered Outcomes Research Institute (PCORI) funding for a 5-year pragmatic clinical trial to compare Anti-TNF Monotherapy versus Combination Therapy with Low Dose Methotrexate in Pediatric Crohn’s Disease. For those who attended and voted at the Fall 2015 Community Conference, you know that there is a study name: COMBINE (Clinical Outcomes of Methotrexate Binary treatment with INfliximab or adalimumab in practicE).
This is the largest trial in which ICN has ever participated, and we can be sure that the entire pediatric IBD community around the world will be watching. As Mike so eloquently stated at the Community Conference, this study will address a research priority for which we are at clinical equipoise: combination or monotherapy?
Physician leaders have commented on the importance of the COMBINE study:
“By having a randomized trial, the COMBINE [study] has an important advantage …(it) ensures that all the other unmeasured factors…are balanced between treatment groups so that any differences seen … are due to the treatment, and not due to some underlying reason for which the physician would have prescribed the medicine. In other words, randomization helps us better understand if the drug is responsible for the differences that are seen between groups.” - Dr. Jeremy Adler
“The key aspects include assessment of disease activity measured via routinely collected labs, short pediatric Crohn's Disease activity index (PCDAI), and hopefully fecal biomarkers as well as routinely collected usual care biologic trough infliximab and antibody levels. We will also be collecting Patient Reported Outcomes (PRO) and will have the capability of collecting long term safety data as most of the patients will be longitudinally followed in the ICN [Network].” - Dr. Shehzad Saeed
What does this study mean for the ICN community? Mike is already gathering a team of clinicians, coordinators, patients and parents to serve as co-investigators. More opportunities may arise. The COMBINE study has ambitious recruitment goals, and Mike and his team will be contacting centers to review criteria for participation. As Mike has stated, the COMBINE study will change the way we conduct research in pediatric IBD, and this is the “logical and inevitable next step in the ICN evolution.”
As members of the ICN community, let’s take the first steps together on this ambitious journey. No one promises it will be easy, but we have the capacity and community to succeed. Let’s get going!
For ImproveCareNow team members seeking more information on the COMBINE study, Michelle Robinson (Project Manager) shared an update on the October Community-wide webinar. Click here to open the slides via the ICN Exchange; the COMBINE update begins on slide #33.