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Clinical Trials and Disease Education

As an IBD (Inflammatory Bowel Disease) Center of Excellence, we have made a commitment to our patients to participate in the Advancement of Science, with goals to contribute to & improve the global understanding & treatment of IBD.  We are proud to offer all IBD patients access to both conventional & novel therapies through a variety of Clinical Trails, ranging from Gut-Specific Antibiotics to Stem-Cell Infusions.  We have been involved in the Research & Development of IBD medications since 1997, collaborating with leaders in medical & pharmaceutical science and have participated in the development of many currently available therapies such as Remicade®, Humira®, Cimzia®, Stelara® and Simponi®.

We invite you to view the Clinical Trials in which we are currently enrolling. Qualified participants will receive Study Medications and Study-related Evaluations at NO Cost. Some weblinks are provided for more detailed information.

ENROLLING TRIALS

Crohn’s Disease

Ulcerative Colitis

FILLED TRIALS

Crohn’s Disease

Ulcerative Colitis

Please contact Amy S. Liebmann, LPN, CCRC or Mindy A. Reynolds, LPN or Sarah A. Jones, if you have any questions at [407] 629-8121 or [877] 4-GI-Health.

 

ENROLLING TRIALS


Crohn’s Disease

BERGAMOT (GA29144)

ENROLLING
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Etrolizumab as an Induction and Maintenance Treatment for Patients with Moderately to Severely Active Crohn’s Disease. IRB Approved: 06/03/2015. (NCT02394028)

GS-US-419-3895

ENROLLING
Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Crohn's Disease. (NCT02914561)

JUNIPER (GA29145)

ENROLLING
An Open-Label Extension and Safety Monitoring Study of Patients with Moderately to Severely Active Crohn’s Disease Previously Enrolled in the Etrolizumab Phase III. IRB Approved: 07/30/2015. (NCT02403323)

LUX (D5170C00002)

ENROLLING
A Phase 2b Double-blind, Multi-dose, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy. (NCT02574637)

MONGERSEN (GED-0301-CD-002)

ENROLLING
A Phase 3, Randomized, Placebo-controlled, Double-blind, Multicenter, Induction Study to Investigate the Efficacy and Safety of GED 0301 For the Treatment of Subjects With Active Crohn's Disease. (NCT02596893)

MONGERSEN (GED-0301-CD-004)

ENROLLING
This is a Phase 3, double-blind, active treatment extension study to evaluate the long-term safety of GED-0301 over 208 weeks in subjects with Crohn's disease (CD) who previously participated inin either of the following two Phase 3 GED-0301 studies: Study GED-0301-CD-002, Study GED-0301-CD-003 (NCT02641392)

PASS (MLN-0002_401) (CD)

ENROLLING
Entyvio (Vedolizumab) long-term safety study: An International Observational Prospective Cohort Study Comparing Vedolizumab to Other Biologic Agents in Patients with Ulcerative Colitis or Crohn’s Disease. IRB Approved: 02/17/2016. (NCT02674308)

SECURE (C87075)

ENROLLING
A Non-Interventional, Long-term, Post-marketing Reigstry of Patients Treated with Certolizumab Pegol (Cimzia®) for Crohn’s Disease. IRB Approved: 01/23/2009. (NCT00844285)

SERENE CD (M14-115)

ENROLLING
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. (NCT02065570)

SERENE CD (M14-347)

ENROLLING
A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn’s Disease. (NCT02185014)

VISIBLE CD (MLN0002SC-3031)

ENROLLING
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease who Achieved Clinical Response Following Open-label Vedolizumab Intravenous Therapy. IRB Approved: 04/01/2016. (NCT02611817)

VISIBLE CD (MLN0002SC-3030)

ENROLLING
A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease. IRB Approved: 04/01/2016. (NCT02620046)
 

Ulcerative Colitis

COTTONWOOD (GA28951)

ENROLLING
An Open-Label Extension and Safety Monitoring Study of Moderate to Severe Ulcerative Colitis Patients Previously Enrolled in Etrolizumab Phase III Studies. (NCT02118584)

GS-US-418-3898

ENROLLING
Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Ulcerative Colitis. (NCT02914522)

HICKORY (GA28950)

ENROLLING
A Phase III, Double Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab during Induction and Maintenance in Patients with Moderate to Severe Active Ulcerative Colitis Who are Refractory to or Intolerant of TNF Inhibitors. (NCT02100696)

LAUREL (GA29102)

ENROLLING
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Maintenance of Remission) and Safety of Etrolizumab Compared with Placebo in Patients with Moderate to Severe Active Ulcerative Colitis Who are Naïve to TNF Inhibitors. (NCT02165215)

LEGACY (P11-282)

ENROLLING
A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis. (NCT01848561)

PASS (MLN-0002_401) (UC)

ENROLLING
Entyvio (Vedolizumab) long-term safety study: An International Observational Prospective Cohort Study Comparing Vedolizumab to Other Biologic Agents in Patients with Ulcerative Colitis or Crohn’s Disease. IRB Approved: 02/17/2016. (NCT02674308)

SERENE UC (M14-033)

ENROLLING
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. (NCT02065622)

VISIBLE UC (MLN0002SC-3030)

ENROLLING
A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease. IRB Approved: 04/01/2016. (NCT02620046)
 

FILLED TRIALS


Crohn’s Disease

IMUNITI (CNTO1275CRD3003)

FILLED
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Effficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease. IRB Approved: 05/16/2011. (NCT01369355)

GED-0301-CD-001

FILLED
A Randomized, Double-Blind, Multicenter Study to Explore the Effect of GED-0301 on Endoscopic and Clinical Outcomes in Subjects with Active Crohn’s Disease. IRB Approved: 10/22/2015. (NCT02367183)
 

Ulcerative Colitis

UNIFI (CNTO1275UCO3001)

FILLED
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis. IRB Approved: 09/29/2015. (NCT02407236)
 
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