Clinical Trials: Digestive Disease Clinical Trials
Guest: Rebekah Whichard – Digestive Disease
Host: Dr. Linda Austin – Psychiatry
Dr. Linda Austin: I am Dr. Linda Austin. I am interviewing Rebekah Whichard who is one of the clinical trial coordinators for the Digestive Disease Center (DDC) here at MUSC. Ms. Whichard, the DDC is now participating in clinical trials for several illnesses including Crohn’s disease and ulcerative colitis. What is Crohn’s disease?
Rebekah Whichard: Crohn’s disease is an autoimmune disorder in which the intestinal tract, the large bowel, small bowel, stomach, becomes inflamed and continues on that inflammation path and creates a lot of rough side effects for patients suffering from the disease. Some signs and symptoms of Crohn’s disease include abdominal pain, abdominal cramping, bloody diarrhea, inability to absorb nutrients when patients eat food.
Dr. Linda Austin: It sounds very uncomfortable.
Rebekah Whichard: It is very uncomfortable for patients.
Dr. Linda Austin: And how long does that illness last?
Rebekah Whichard: It can start when patients are in their teens or even younger sometimes. We see patients being diagnosed in their 20s and 30s, and then again in their 50s and 60s we see the increase in disease.
Dr. Linda Austin: What are some of the standard treatments for Crohn’s disease?
Rebekah Whichard: Some of the standard treatments include prednisone. We have 5-ASAs or medications such as pentasa, rowasa, canasa, asacol. Those are some of the traditional treatments. Sulfasalazine has been out on the market for many years.
Dr. Linda Austin: Now, how is Crohn’s disease different from ulcerative colitis?
Rebekah Whichard: Ulcerative colitis affects just the large intestine whereas Crohn’s disease can affect pretty much any portion of the digestive tract.
Dr. Linda Austin: So, it is the same illness, just manifesting itself in different parts of the intestine, is that right?
Rebekah Whichard: Yes.
Dr. Linda Austin: And is ulcerative colitis treated with those same agents for Crohn’s disease?
Rebekah Whichard: Yes, for the most part it is.
Dr. Linda Austin: The DDC has several clinical trials going on now for Crohn’s disease and ulcerative colitis. What sort of patient should start thinking about whether or not to participate in a clinical trial?
Rebekah Whichard: Many of our patients have pretty much exhausted all other means of therapy. These patients are not responding or cannot tolerate the current traditional therapies that are on the market. So, a lot of them come to us looking for other options to help get their disease under control. In the case of ulcerative colitis, some patients want another option instead of having to have a colectomy. So, they come to us to see what we can offer.
Dr. Linda Austin: And I would think since prednisone, in particular, has such significant side effects, perhaps there are those who either cannot tolerate prednisone or do not want to tolerate prednisone.
Rebekah Whichard: Right. A lot of patients are on long-term prednisone use. We like to get those patients off it. It is not a good thing to be on it for a significant amount of time. So, we work with the other available therapies to discontinue prednisone use.
Dr. Linda Austin: I know that there are a number of clinical trials going on with different agents. Can you talk a little bit about what some of the options are in the clinical trials?
Rebekah Whichard: We are looking for patients that have pretty much exhausted all means of therapy. We are looking for patients that have not had good results with,
or cannot tolerate, biologic therapy such as remicade or humira. Those are some of the newer medications on the market that do well in treating the disease.
Dr. Linda Austin: So, you are using, then, different medications, new medications, that hopefully will be available on the market after these clinical trials have been completed?
Rebekah Whichard: That is correct. We are actually moving into more the biologics to help treat inflammatory bowel disease these days.
Dr. Linda Austin: How long do the clinical trials last, if one participates?
Rebekah Whichard: Our clinical trials can be as short as 8 to 12 weeks of participation. We do have a couple of clinical trials that last until the drug gets approved by the FDA. A lot of our clinical trials are in the final stages of testing prior to going for FDA approval. These sponsors are keeping patients in the clinical trials, and open label portions of clinical trials, until the drugs are FDA approved.
Dr. Linda Austin: How many clinical trials are currently on-going at the Digestive Disease Center?
Rebekah Whichard: We have approximately 60 clinical trials in several areas at the Digestive Disease Center, including pancreas trials, berets esophagus, acid reflux, Crohn’s disease and ulcerative colitis. We also have some liver trials and some cancer trials as well.
Dr. Linda Austin: Wow, a very active roster of scientific investigation going on there.
Rebekah Whichard: Yes.
Dr. Linda Austin: So, if a patient is interested in just learning more, what would be the next step?
Rebekah Whichard: They can check our website, www.ddc.musc.edu. They can also get some great information at www.clinicaltrials.gov.
Dr. Linda Austin: And we will put that in graphics on this website as well. Is there a number that they can call if they wanted to talk with a coordinator?
Rebekah Whichard: Yes, they can contact us at 843-792-6999 and ask for the clinical trials team.
Dr. Linda Austin: And am I right in thinking that they can also talk to, or maybe should talk to, their primary care provider as well, in their home town, about their interest in MUSC clinical trials?
Rebekah Whichard: Yes, we encourage patients to speak with their treating physician as well as their family and friends about clinical trials.
Dr. Linda Austin: So that you can communicate with the primary care physician and vice versa?
Rebekah Whichard: Yes, we do like to the primary care physician included as to the patient’s status and participation, if the patient desires, in clinical trials.
Dr. Linda Austin: Rebekah, thank you so much for talking with us today.
Rebekah Whichard: Thank you.
If you have any questions about the services or programs offered at the Medical University of South Carolina or if you would like to schedule an appointment with one of our physicians, please call MUSC Health Connection: (843) 792-1414.