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Clinical trial studies a new drug for ulcerative colitis sufferers
Ulcerative colitis
For individuals with ulcerative colitis (UC), the symptoms can take a significant toll, both physically and emotionally. A chronic relapsing, inflammatory disease of the colon, symptoms of UC include cramping, diarrhea, fatigue, and bleeding.
While the cause of UC is unknown, it is most commonly diagnosed in late adolescence and early adulthood, with symptoms reaching their peak between the ages of 20-39. The disease occurs as a result of an abnormal immune response in the gut, to which sufferers may be genetically predisposed.
In treating UC, the main goal is remission and the ability to maintain remission (remission is defined as a period when symptoms are reduced or disappear). At present, no current pharmacological (drug) therapy is able to provide a cure. Therefore, the identification of new, effective treatment is an important area on which researchers are focusing.
The OCTAVE Trials
Researchers are currently conducting four clinical trials, called the OCTAVE Trials, for people with moderate to severe UC at approximately 300 locations in 32 countries worldwide. Aurora Medical Center in Summit is one of the U.S. locations where the study will be conducted. Nimish B. Vakil, MD, a gastroenterology specialist is leading the study at Aurora Health Care.
The OCTAVE trials are part of a Phase 3 clinical program designed to test the efficacy and safety of the new investigational drug called tofacitinib, an oral pill (taken by mouth) for people with UC. It is a “double-blind, randomized, placebo-controlled” clinical research trial. All participants are randomized by a computer program into study groups. Double-blind refers to the fact that neither the principal investigators nor any of the participants know into which group any participant is placed, or which person is taking the drug tofacitinib or a placebo. These details of the trial must remain anonymous to ensure the validity of the data.
Participating in this clinical trial
Participants must by at least 18 years of age. Participants must have been diagnosed with ulcerative colitis for more than four months, have persistent symptoms under current medication(s) and meet other criteria in order to participate. Participants must be willing to follow a study plan, study-related scheduled visits and procedures, daily diary phone call-in and other study procedures. For individuals who are eligible and decide to enroll in this clinical trial, their participation will last approximately 12–16 weeks.
Aurora Medical Center in Summit, WI is continuing to screen patients for enrollment in the OCTAVE clinical trial. For information or to learn who may benefit from this procedure, contact research coordinator Debbie Smith, at 262-434-5846, [email protected].
Research at Aurora Health Care offers more than 700 clinical research opportunities including approximately 400 clinical trials. Through these studies, many of the 1.2 million patients served across Aurora are given access to new therapies, drugs and devices in the core service areas of cardiology, oncology, women’s health and neurology. Randall Lambrecht, PhD, Senior Vice President of Research and Academic Relations, emphasizes, “Not only does Aurora offer innovative research opportunities it is also a clinical setting that is focused on improved patient outcomes and optimal delivery of health care.”
Ulcerative colitis
For individuals with ulcerative colitis (UC), the symptoms can take a significant toll, both physically and emotionally. A chronic relapsing, inflammatory disease of the colon, symptoms of UC include cramping, diarrhea, fatigue, and bleeding.
While the cause of UC is unknown, it is most commonly diagnosed in late adolescence and early adulthood, with symptoms reaching their peak between the ages of 20-39. The disease occurs as a result of an abnormal immune response in the gut, to which sufferers may be genetically predisposed.
In treating UC, the main goal is remission and the ability to maintain remission (remission is defined as a period when symptoms are reduced or disappear). At present, no current pharmacological (drug) therapy is able to provide a cure. Therefore, the identification of new, effective treatment is an important area on which researchers are focusing.
The OCTAVE Trials
Researchers are currently conducting four clinical trials, called the OCTAVE Trials, for people with moderate to severe UC at approximately 300 locations in 32 countries worldwide. Aurora Medical Center in Summit is one of the U.S. locations where the study will be conducted. Nimish B. Vakil, MD, a gastroenterology specialist is leading the study at Aurora Health Care.
The OCTAVE trials are part of a Phase 3 clinical program designed to test the efficacy and safety of the new investigational drug called tofacitinib, an oral pill (taken by mouth) for people with UC. It is a “double-blind, randomized, placebo-controlled” clinical research trial. All participants are randomized by a computer program into study groups. Double-blind refers to the fact that neither the principal investigators nor any of the participants know into which group any participant is placed, or which person is taking the drug tofacitinib or a placebo. These details of the trial must remain anonymous to ensure the validity of the data.
Participating in this clinical trial
Participants must by at least 18 years of age. Participants must have been diagnosed with ulcerative colitis for more than four months, have persistent symptoms under current medication(s) and meet other criteria in order to participate. Participants must be willing to follow a study plan, study-related scheduled visits and procedures, daily diary phone call-in and other study procedures. For individuals who are eligible and decide to enroll in this clinical trial, their participation will last approximately 12–16 weeks.
Aurora Medical Center in Summit, WI is continuing to screen patients for enrollment in the OCTAVE clinical trial. For information or to learn who may benefit from this procedure, contact research coordinator Debbie Smith, at 262-434-5846, [email protected].
Research at Aurora Health Care offers more than 700 clinical research opportunities including approximately 400 clinical trials. Through these studies, many of the 1.2 million patients served across Aurora are given access to new therapies, drugs and devices in the core service areas of cardiology, oncology, women’s health and neurology. Randall Lambrecht, PhD, Senior Vice President of Research and Academic Relations, emphasizes, “Not only does Aurora offer innovative research opportunities it is also a clinical setting that is focused on improved patient outcomes and optimal delivery of health care.”
