Ulcerative Colitis
Ulcerative Colitis
Ulcerative Colitis is a chronic inflammatory condition that causes long-lasting inflammation and ulcers in the inner lining of the large intestine or colon. Ulcerative colitis differs from Crohn's disease in that Crohn's can affect any part of the Gastrointestinal (GI) tract, whereas ulcerative colitis affects only the colon.
Most patients with ulcerative colitis have mild to moderate symptoms. If left untreated however, these symptoms can lead to other, more serious complications.
While there is a wide range of severity and symptoms among patients with ulcerative colitis, common symptoms include:
- rectal bleeding
- abdominal pain and cramping
- persistent diarrhea
- loose and more urgent bowel movements
- loss of appetite
- fatigue
Fortunately, there are several treatment options available for people living with Ulcerative colitis. While there is no known cure, these treatments work to reduce the signs and symptoms of the disease and introduce long-term remission.
If you have not had success with available treatment options, search the clinical trials listed below and talk with your doctor about clinical trials you may be eligible for. Scientists and researchers are continually working to find ways to improve the quality of life for people living with Ulcerative Colitis.
At Vanderbilt's GI Clinical Research Enterprise, we are dedicated to finding a solution that works for you.
Currently enrolling trials for Ulcerative Colitis
Title: A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
(UNIFI)
Study Contact: Eric Howard 615-322-7403 eric.f.howard@Vanderbilt.Edu
Principal Investigator: Dawn Beaulieu, MD
This is a Phase 3, randomized, double-blind, placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), parallel-group, multi-center, protocol of ustekinumab. The protocol will consist of 2 studies: an Induction study and a Maintenance study with unique endpoints. Screening period will be up to 8 Weeks. Induction study will be at least 8 weeks duration for each participant. Participant with clinical response in the Induction study will be eligible for the Maintenance study. The Maintenance study will be 44 weeks duration. After completion of the maintenance study, a long term extension will follow eligible participants for an additional 3 years. Clinical remission will be evaluated at Week 8 in the Induction study. Clinical remission among ustekinumab Induction responders will be evaluated at week 44 in the Maintenance study. Participants' safety will be monitored throughout.
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Title: A Study of the Efficacy and Safety of Etrolizumab in Ulcerative Colitis Patients Who Are Refractory to or Intolerant of TNF Inhibitors
(GA28950 - Hickory)
Study Contact: Erin Landry 615-322-4573 Erin.vozar@vanderbilt.edu
Principal Investigator: David A. Schwartz, MD
This phase III, double blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission in patients with moderately to severely active ulcerative colitis (UC) who are refractory to or intolerant of tumor necrosis factor (TNF) inhibitors.
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Open Label Extension
Title: Open-label Extension and Safety Study for Patients With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase III Studies
(GA28951 - Cottonwood)
Study Contact: Erin Landry 615-322-4573 Erin.vozar@vanderbilt.edu
Principal Investigator: David A. Schwartz, MD
This two-part, open-label extension (OLE) and safety monitoring (SM) study will examine the efficacy and safety of continued etrolizumab treatment in moderate to severe ulcerative colitis (UC) patients previously enrolled in etrolizumab Phase III studies.
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Title: A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
(M14-033)
Study contact: Erin Landry 615-322-4573 Erin.vozar@vanderbilt.edu
Principal Investigator: Sara Horst, MD
To evaluate safety and efficacy of two dosing regimens in achieving clinical remission at Week 8 in subjects with moderately to severely active Ulcerative Colitis.
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Title: Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis
(RPC01-3101)
Study Contact: Erin Landry 615-322-4573 Erin.vozar@vanderbilt.edu
Principal Investigator: David A. Schwartz, MD
The trial is composed of 2 periods: Induction and Maintenance. Patients will be entered into the trial in 2 separate cohorts through the Induction Period (10 weeks) and those patients in clinical response at the end of the Induction Period will proceed through to the Maintenance Period. Participation in these periods will be 52 weeks. Patients may also qualify to participate in an optional Open-Label Extension study.
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Title: A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease
(PIANO)
Study Contact: Amy Motley 615-322-6281 amy.motley@vanderbilt.edu
Principal Investigator: Dawn Beaulieu, MD
The aim of this study is to determine the effect of medication use and disease activity on the outcome of pregnancy among women with IBD up to 4 years from birth.
All pregnant women with IBD diagnosis who are taking biologics medicines and immunosuppressants can be entered in the study.
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Title: An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants with Ulcerative Colitis
(Takeda 3026)
Study Contact: Eric Howard 615-322-7403 eric.f.howard@vanderbilt.edu
Principal Investigator: Sara Horst, MD
The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment period.
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Title: Safety and Efficacy of GS-5745 in Participants With Moderately to Severely Active Crohn's Disease
(GS-US-395-1100)
Study Contact: Melanie Dean 615-396-1745 melanie.j.dean@vanderbilt.edu
Principal Investigator: Sara Horst, MD
This study will primarily evaluate the safety and efficacy of GS-5745 in adults with active Crohn's disease. The study will consist of a Blinded Treatment Period of 8 weeks followed by an Open Label Extension. Participants who complete the Blinded Treatment Period will be eligible to enroll in the optional Open Label Extension for an additional 44 weeks. Participants who complete Week 52 assessments will be eligible to enter the Extended Treatment Phase to continue treatment with GS-5745 for an additional 156 weeks.