Clark County residents with ulcerative colitis may have a new treatment option if previous medications were unsuccessful in managing symptoms.
Dr. Jason Etzel, a gastroenterologist at The Vancouver Clinic, is participating in one of a family of Phase 3 clinical trials, called Etro Studies. Etzel is participating in the study that compares investigational ulcerative colitis medication with a placebo.
Etzel hopes to enroll at least four patients in the study, which lasts about one year.
“The hope is that by enrolling our four patients that we add to the advancement of science and treatment of ulcerative colitis,” he said.
Ulcerative colitis is an inflammatory bowel disease that causes long-lasting inflammation and ulcers in the digestive tract.
Most ulcerative colitis medications impact the immune system, Etzel said. The drugs essentially suppress a person’s immune system to get symptoms under control, he said.
The medication in the clinical trial, however, selectively impacts the immune system. It lowers the immune system’s ability to move white blood cells, but doesn’t suppress the entire immune system, Etzel said. As such, the test drug should theoretically have lower risk of infections and other side affects, he said.
“In the early studies of this drug, that’s borne out,” Etzel said. “This current study will test that with the overall population.”
Improving access
A similar drug has already been approved by the FDA.
“The problem is, it’s horribly expensive,” Etzel said. “It works very similarly (to the trial drug), but it’s the most expensive drug out there.”
Insurance companies don’t typically cover the drug, making it out of reach for most patients, Etzel said. This trial, however, could change that, he said.
“It gives us an opportunity for patients who we think would really benefit from this (type of) medication, but who don’t have access to it,” he said.
The medication is for someone who has moderate or severe ulcerative colitis. The trial is ideal for someone who has tried immunosuppressants and has not gotten a good response or someone who cannot afford the drugs, Etzel said.
Trial participants will receive an injection of the medication every four weeks. After the first few doses, patients will be able to administer the drug themselves at home. Patients will also be given a tablet device to monitor their symptoms daily.
Etzel will monitor the drug’s effectiveness through three limited colonoscopies — one before taking the drug, one in the middle of the trial and one at the end of the trial.
“That’s the most invasive part of the study,” he said.
Some of the participants may receive a placebo. Like the participants, Etzel will not know who is receiving the drug and who is receiving placebo. That information will be revealed at the end of the trial, however.
However, every patient enrolled in the study is eligible to receive the active drug. A person receiving placebo, for example, is eligible to receive the drug after he or she completes the study.
The trial also has a long-term extension. Participants who are seeing results from the drug can continue to receive the medication for up to seven years for free, Etzel said.
Those who are interested in participating in the trial should call The Vancouver Clinic’s research department, 360-397-3387.
