A new clinical trial by UC Health inflammatory bowel disease (IBD) experts is looking at how a patient database can help physicians learn long-term effects associated with a certain anti-inflammatory medication used to treat Crohn’s disease.
Richard Rood, MD, medical director of the UC Inflammatory Bowel Disease program, says the database will specifically be looking at the medication Cimzia (certolizumab pegol), used to lessen the signs and symptoms of Crohn’s disease, a common type of IBD. Cimzia is one group of medications known as "biological agents” which are used to eliminate some of the chemicals in the body that cause inflammation.
"This registry will help physicians gather data about which patients respond to the treatment, how long they respond and whether or not we can predict who will respond ahead of time,” he says.
"A lot of this type of information is often garnered before the drug goes into the pharmaceutical market. However, this trial is unique because it is collecting long-term information about patients’ experience with the medication, which has already been approved by the Food and Drug Administration.”
IBD occurs when the immune system attacks the gastrointestinal (GI) tract. Crohn’s disease can affect any part of the GI tract and inflame all layers of the intestinal wall. It usually begins in younger years, generally in the teens and 20s.
Besides causing abdominal pain, bloody stools, diarrhea and other serious problems, such as growth failure because of a lack of nutrients, individuals with IBD have an increased risk of colorectal cancer.
"The disease is treatable but cannot be cured,” Rood says. "However, the majority of patients are well controlled with known treatments. Long-term studies, like this, are important for the care of patients with this life-long disease.”
He says the 10-year registry will also look at long-term side effects of this particular treatment and because of the length of the study will hopefully offer information about what to expect fromthis class of medication.
"This database has the potential to be a very important point of reference and a model for researchers to discover the effects of medications on certain patient populations,” he says. "To my knowledge, there hasn’t been a trial like this that has followed patients treated with this class of biologic agents for such a long period of time.”
Rood says patients will be contacted and asked questions from a survey about their condition every three months. This is in addition to regular clinical visits to digestive diseases specialists.
"We hope that this study will create opportunities to develop similar registries, following and tracking other medications and treatments,” he says.
"With this information, we can find out why certain medications work better for some patients and not work for others, enhancing the way physicians practice and delivering the best, most efficient care for patients.”
This study is funded by UCB, makers of Cimzia. Rood cites no honoraria. For more information, call (513) 475-7505.