Crohns Disease

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Crohn's Disease

Crohn's Disease is a chronic inflammatory condition of the gastrointestinal tract affecting as many as 700,000 Americans, typically between the ages of 15 and 35. While the cause of Crohn's Disease is not well understood, recent research suggests hereditary, genetics, and/or environmental factors contribute to its development.

Crohn's disease causes inflammation in the lining of the digestive tract which can be very painful and sometimes debilitating. The symptoms of Crohn's disease vary from patient to patient in both presence and severity, but common symptoms include:

• Abdominal cramping and pain
• Persistent diarrhea
• Rectal bleeding
• Constipation
• Fever
• Nausea or loss of appetite
• Fatigue
• Weight loss

Since Crohn's is a chronic disease, patients usually experience flares with obvious symptoms followed by periods of remission when they may not notice any symptoms at all. If left untreated, Crohn's disease can lead to serious complications. 

Fortunately, there are several treatment options available for people living with Crohn's disease. 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 Crohn's disease.

At Vanderbilt's GI Clinical Research Enterprise, we are dedicated to finding a solution that works for you.

 

Currently enrolling studies for Crohn's Disease

Title: Safety and Efficacy of GS-5745 in Participants With Moderately to Severely Active Crohn's Disease
(GS-US-395-1663)

Study Contact: Melanie Dean 615-936-1745 melanie.j.dean@vanderbilt.edu

Principal Investigator: Dawn Beaulieu, 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.

Click here for more information about this study
 

Title: Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease
(GED-0301-CD-002)

Study Contact: Melanie Dean 615-936-1745 melanie.j.dean@vanderbilt.edu

Principal Investigator: David Schwartz, MD
 

The purpose of study is to test the effects of an experimental medication GED-0301 (mongersen) in patients who have active Crohn's disease. The study will test GED-0301 compared to placebo for 52 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn's disease.

After 12 weeks in the study until the end of the study, patients who do not have an improvement in their Crohns disease symptoms will have the option to enter a long term active treatment study.

Click here for more information about this study

Title: A Study of the Safety and Efficacy of Etrolizumab in Patients With Moderately to Severely Active Crohn's Disease
(GA29144 - Bergamot CD)

Study Contact: Eric Howard   615-322-7403  eric.f.howard@Vanderbilt.Edu

Principal Investigator: David Schwartz, MD
 

This is a multicenter, Phase III, double-blind, placebo-controlled study evaluating the safety and efficacy of etrolizumab during induction and maintenance treatment of moderate to severely active Crohn's disease (CD) in patients who are anti-tumor necrosis factor (TNF) naive (TNF-naive) and in patients who are refractory or intolerant of tumor necrosis factor inhibitors.
 

Click here for more information about this study
 

Enrolling by invitation only

Title: Open-Label Extension and Safety Study for Patients With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144​
(GA29145 - Juniper CD)
 

Study Contact: Eric Howard  615-322-7403 eric.f.howard@Vanderbilt.Edu

Principal Investigator: David Schwartz, MD
 

This two-part, open-label extension and safety monitoring study will examine the safety and efficacy of continued etrolizumab treatment in patients with moderate to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144.
 

Click here for more information about this study 
 

Title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Adalimumab Induction Regimens in Subjects With Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration
(M14-115)
 

Study Contact: Erin Landry    615-322-4573    Erin.vozar@vanderbilt.edu   

Principal Investigator: Sara Horst, MD
 

This study will evaluate the efficacy and safety of two adalimumab induction regimens in subjects with moderately to severely active Crohn's disease and evidence of mucosal ulceration.
 

Click here for more information about this study
 

Enrolling by Invitation Only

Title: Open Label Study to Evaluate Long Term Efficacy, Safety and Tolerability of Repeated Dosing in Subjects With Crohn's Disease and Who Participated and Successfully Completed M14-115
​(M14-347)
 

Study contact: Erin Landry    615-322-4573    Erin.vozar@vanderbilt.edu   

Principal Investigator: Sara Horst, MD
 

This study will evaluate the long term efficacy, safety, and tolerability of repeated administration of adalimumab in subjects with Crohn's disease.
 

Click here for more information about this study
 

Enrolling by Invitation Only

Title: SECURE, the Cimzia ® Crohn's Disease Post-Marketing Registry

Study Contact: Erin Landry    615-322-4573    Erin.vozar@vanderbilt.edu   
Principal Investigator: Sara Horst, MD

The purpose of this study is to monitor safety outcomes of patients who have taken Cimzia® as compared to a non- Cimzia® control population. The SECURE Registry's target enrollment is 4000 patients and it's objective is to monitor patients for approximately 10 years.
 

Click here for more information about this study
 

Title: Impact of Medical Treatment on Sexual Function in Patients With Crohn's Disease

Study Contact: Erin Landry    615-322-4573    Erin.vozar@vanderbilt.edu   
Principal Investigator: Sara Horst, MD
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This is a 6 month study to compare sexual function before and after treatment in patients with Crohn's disease about to initiate therapy with an anti-TNF drug for treatment of perianal fistula or intestinal Crohn's or about to initiate therapy with steroids.

The investigators anticipate that the investigators will show that therapy with an anti TNF agent will result in a more rapid and greater return of sexual function than steroids. This information will be important to help counsel patients about the optimal treatment to begin for treatment of their Crohn's disease. Furthermore, it would be the first study to evaluate the impact of medical therapy on sexual function.
 

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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.

Click here for more information about this study