Clinical studies are research studies; people help doctors and researchers find ways to improve health care and to prevent, diagnose, or treat disease. We offer our patients the opportunity to participate in clinical studies of new, investigational drug therapies for ulcerative colitis and Crohn's disease.
Our doctors oversee our clinical studies. The goal of these studies is to find new therapies to improve health of patients with IBD. We also hope our research will someday lead to a cure for IBD.
Current Clinical Studies
Volumetric Fat Ratio Measurement and Ileocolectomy Outcomes In Crohn's Disease Patients
There has been a recent increase of obesity in the IBD population. Obesity is associated with worse surgical outcomes in many types of surgery, including surgery for colorectal surgery. However, the effect of obesity on operative outcomes in IBD is understudied. The aim of this study is to use visceral and subcutaneous fat measurements from computerized tomography (CT) images taken prior to surgery to predict outcomes after ileocolectomy for Crohn's disease. This is a collaborative project under the direction of Dr. E. Messaris in the Division of Colon and Rectal Surgery and Dr. R. Tappouni in the Department of Radiology using Intuition® software and data from the IBD Biobank.
- Tara Connelly MD
- Evangelos Messaris MD, Ph.D.
Dr. Marc Schaefer is the physician leader for ImproveCareNow at Penn State Hershey Children's Hospital. ImproveCareNow is a collaborative network of over 50 pediatric gastroenterology divisions throughout the United States and London, England, that is focused on quality improvement in pediatric inflammatory bowel disease. Penn State Hershey Children's Hospital joined the ImproveCareNow network in the last year and plans to start enrolling patients in the next several months. The purpose of participation in ImproveCareNow is to drive improvements in the care and health of all kids with Crohn's disease and ulcerative colitis. The overall goal of participation in ImproveCareNow is to increase our percentage of IBD patients that are in remission, meaning having inactive disease and a high quality of life.
A single Center Experience regarding Vaccination status in IBD patients on infliximab: Patient and Provider surveys
Vaccination practices for those currently taking anti-TNF treatment varies by clinician. Additionally, some patients elect not to undergo vaccination due to their immunosuppression. In this ongoing study, patients and physicians are contacted by survey and questioned regarding vaccination status and practices for patients on the anti-TNF drug infliximab. To date, over 70 physicians have responded. Patient and additional physician recruitment is ongoing.
Quality of Life and Smoking Post Ileal Pouch Anal Anastomosis in UC
This is a questionnaire based study and a collaborative effort between the Division of Colon and Rectal Surgery and the Department of Gastroenterology under the direction of Dr. Emmanuelle Williams. The aim of the study is to identify factors affecting quality of life that are present either preoperatively or postoperatively after ileal pouch anal anastomosis for ulcerative colitis. A particular focus of the study is to determine the effect of smoking on quality of life.
- Tara Connelly, MD
- Emmanuelle Williams, MD
Randomized, double blind, prospective trial investigating the efficacy of Methotrexate in induction and maintenance of steroid free remission in ulcerative colitis (Methotrexate Response In Treatment of UC - MERIT-UC)
Steroid free remission is a key indicator of the successful treatment of IBD. This is a randomized, double blind, multicenter prospective trial of which the IBD Center is a member. The aim of the study is to evaluate the role of Methotrexate in inducing and maintaining remission as measured by the avoidance of steroids in ulcerative colitis.
Use of Certolizumab Following Ileocolectomy Lowers Endoscopic and Histological Recurrence Rates for Crohn's Disease at One Year Compared to Mesalamine (IRB 36497)
This is a prospective, randomized controlled trial which is being undertaken only at Hershey Medical Center. Patients who require surgery for Crohn's disease in the form of an ileocolectomy, and who are willing to participate, are randomized to receive either mesalamine or Cimzia for one year, with these study medications paid for by the study sponsor. The focus of the study is to determine whether either drug is superior at preventing recurrent Crohn's disease.
How Does a Clinical Trial Work?
Every clinical trial in the United States must be approved and monitored by an institutional review board (IRB) to make sure the risks are as low as possible, and worth any potential benefits.
After you are accepted by the clinical trial and you give your consent, you will receive a structured program to follow that may require:
- A schedule of tests, doctor appointments, and treatments
- Keeping a diary of your experience during this time
Clinical studies usually require you to have more medical tests than you would have if you were not in the trial.
After a clinical trial is completed and the data collected is studied, the Food and Drug Administration decides whether to approve continued development of the medicine. If the medicine that you received remains in development, you may be able to receive additional doses as an extension of the study.
If the results of the clinical trial show that the new drug therapy works much better than standard treatment, the new drug may become available to the general public.
Is it Safe to Participate in a Clinical Study?
Clinical studies are safe and under the guidance of skilled doctors. They are regularly reviewed by independent safety committees to insure no significant negative events occur. All such studies have to be first approved by an institutional review board for safety. All your questions will be answered though a careful consent process. Study patients can withdraw from the trial at anytime. However, it is important to realize that:
- The new treatment may not work well for you.
- Many studies may have a "sugar pill" group which you may receive instead of the study drug
- You may experience side effects from the treatment
You should feel free to talk to our team at any time during the trial if you have questions or concerns.
How to Participate in a Clinical Study
If you are interested in participating in a clinical study, contact our dedicated IBD Coordinator at 717-531-3998 or the Penn State Hershey Careline at 1-800-243-1455.
ABC 27 Call-In Show featuring Fran Puleo, M.D., Penn State Hershey Colorectal Surgeon: Pelvic Floor Dysfunction - October 23, 2014