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®, Orencia® and Tysabri®.

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.

Coming Soon Abbott M12-489 Alba Therapeutics CLIN1001-012		MERIT Ulcerative Colitis UCB Protocol CR0011
ENROLLING TRIALS
Crohn’s Disease Centocor CNTO1275CRD3001 UNITI1 Centocor CNTO1275CRD3002 UNITI2 Centocor CNTO1275CRD3003 IMUNITI Cimzia Capsule Study Coronado Biosciences Protocol Cndo 201-002 Millenium C13011 Osiris Protocol 603 Osiris Protocol 611 Remicade CRD 3001 Secure Registry C87075 Tsumara USA Protocol TU100P2T2		Diverticulitis Dr. Falk Pharma SAG-51 Iron Deficiency Anemia AMAG Pharmaceuticals AMAG-FER-IDA-301 Ulcerative Colitis Bristol-Myers Squibb IM129-005 DREAM Study
Ulcerative Proctitis or Proctosigmoiditis Salix BFPS3073 OL Extension to BUCF 3002 Salix BUCF2002
FILLED TRIALS
Crohn’s Disease Abbott M10-222 Bristol-Myers Squibb Protocol IM101-084 Centocor C0743T26 Millennium Protocol C13007A (Gemini II) Millennium Protocol C13007B (Gemini II) Millennium Protocol C13008 (Gemini III) UCB Cimzia Protocol C87085 UCB Cimzia Protocol C87088 Hutchison MediPharma HPML-004 Protocol 200500401		Ulcerative Colitis Abbott MO6-827 Abbott M10-223 Bristol-Myers Squibb Protocol IM101-108 Centocor Protocol C0524T17 Centocor Protocol C0524T18 Cosmo CB-01-02/01 Hollis-Eden HE3286-0301 Hutchinson MediPharma HPML-004-US-02 Millennium Protocol C13006A (Gemini I) Millennium Protocol C13006B (Gemini I) Millennium Protocol C13008 (Gemini I) Shire Pharmaceutical DEAR Phase 4
Diverticulitis Procter and Gamble DIVA Protocol 2007020		Irritable Bowel Syndrome Salix Protocol RFIB3007
Ulcerative Proctitis or Proctosigmoiditis Axcan Pharma CD-ME-CAPSITUP508-01

Please contact our Clinical Coordinator, Peggy Galvis, RN or Renee DePanicis, RN, if you have any questions at [407] 628-8121 or [877] 4-GI-Health.

 

Coming Soon

Abbott M12-489

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Adalimumab for the induction of Clinical Remission in Adult Subjects with Mild to Moderate Crohn’s Disease and Elevated C-Reactive Protein(CRP).

Alba Therapeutics CLIN1001-012

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Different Doses of Larozotide Acetate for the Treatment of Celiac Disease. (NCT01396213)

MERIT Ulcerative Colitis

Randomized, Double Blind, Prospective Trial investigating the efficacy of Methotrexate in the Induction & Maintenance of Steroid-Free Remission in Ulcerative Colitis.
(MEthotrexate Response In Treatment of UC: MERIT)

UCB Protocol CR0011

A Phase 3, Multi-Center, Double-Blind, Randomized Study to Evaluate Treatment Optimization Based on Clinical and Laboratory Driven Clinical Decisions for Treatment with Certolizumab Pegol in Subjects with Moderately to Severely Active Crohn’s Disease.
 

ENROLLING TRIALS

Crohn’s Disease

Centocor CNTO1275CRD3001 UNITI1

A Phase 3, Randomized, Double-Blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohns Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy. (NCT01369329)

Centocor CNTO1275CRD3002 UNITI2

A Phase 3, Randomized, Double-Blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohns Disease. (NCT01369342)

Centocor CNTO1275CRD3003 IMUNITI

A Phase 3, Randomized, Double-Blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohns Disease. (NCT01369355)

Cimzia Capsule Study

Open Label Investigator Initiated, Single Site Study of Mucosal Healing in Patients With Small Bowel Crohn's Disease Treated With Certolizumab Pegol (Cimzia) Assessed by Wireless Capsule Endoscopy. (NCT01053559)

Coronado Biosciences Protocol Cndo 201-002

A Sequential Dose-Escalation, Double-Blind, Placebo-Controlled Phase I Study To Evaluate The Safety And Tolerability Of Single Doses Of 3 Different Doses Of Oral Cndo 201 Tichursis Suis Ova Suspension (Tso) In Patients With Crohn’s Disease. (NCT01434693)

Millenium C13011

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease. (NCT01224171)

Osiris Protocol 603

A Phase III, multicenter, placebo-controlled, randomized, double-blind study to evaluate the safety and efficacy of Prochymal (ex vivo cultured adult human mesenchymal stem cells) intravenous infusion for the induction of remission in subjects experiencing treatment refractory moderate to severe Crohn’s disease. (NCT00482092)

Osiris Protocol 611

A Multicenter, Open-label Study to Evaluate the Safety of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects Who Have Received Previous Remestemcel-L Induction Treatment for Treatment-refractory Moderate-to-severe Crohn's Disease. (NCT01233960)

Remicade CRD 3001

Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at Increased Risk of Recurrence. (NCT01190839)

Secure Registry C87075

A Non-Interventional Long-Term Post Marketing Registry of Patients Treated With Certilizumab Pegol (Cimzia) for Crohn’s Disease. (NCT00844285)

Tsumara USA Protocol TU100P2T2

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Daikenchuto (TU-100) in Subjects with Moderate Crohn’s Disease. (NCT01388933)
 

Diverticulitis

Dr. Falk Pharma SAG-51

Double-blind, Randomized, Placebo-controlled, Parallel Group, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Mesalazine Granules vs. Placebo for the Prevention of Recurrence of Diverticulitis. (NCT00695643)
 

Iron Deficiency Anemia

AMAG Pharmaceuticals AMAG-FER-IDA-301

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia. (NCTO1374919)
 

Ulcerative Colitis

Bristol-Myers Squibb IM129-005

A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC). (NCTO1294410)

DREAM Study

An Investigation into Diet and its Role with Exacerbations of Ulcerative Colitis.
(Diet's Role in Exacerbations of Asacol Maintenance: DREAM)
 

Ulcerative Proctitis or Proctosigmoiditis

Salix BFPS3073 OL Extension to BUCF 3002

A Phase 3, Open Label,Multicenter Study To Assess The Safety And Tolerability Of Budesonide Foam In Subjects With Active Proctitis Or Proctosigmoiditis. (NCT01349673)

Salix BUCF2002

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Budesonide Foam Versus Placebo in Subjects With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis. (NCT01008410)
 

FILLED TRIALS

Crohn’s Disease

Abbott M10-222

A Phase IIB, Multi-Center, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose Ranging Study Comparing the Efficacy, Safety, and Pharmacokinetics of Intravenous Infusions of ABT-874 vs. Placebo in Subjects with Moderately to Severely Active Crohn’s Disease. (NCT00562887)

Bristol-Myers Squibb Protocol IM101-084

A Phase III, Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy. (NCT00406653)

Centocor C0743T26

A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Previously Treated with TNF Antagonist Therapy. (NCT00771667)

Millennium Protocol C13007A (Gemini II)

A Phase III, Randomized, Placebo-Controlled, Double-Blind, Multicenter, Multiple Dose Study to Determine the Efficacy and Safety of MLN0002 for the Induction of Clinical Response and Remission in Patients with Moderate to Severe Crohn’s Disease. (NCT00783692)

Millennium Protocol C13007B (Gemini II)

A Phase III, Randomized, Placebo-Controlled, Double-Blind, Multicenter, Multiple Dose Study to Determine the Efficacy and Safety of MLN0002 for the Maintenance of Clinical Response and Remission in Patients with Moderate to Severe Crohn’s Disease. (NCT00783692)

Millennium Protocol C13008 (Gemini III)

A Phase III, Multiple Dose, Open-Label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease. (NCT00790933)

UCB Cimzia Protocol C87085

A phase IIIB, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab’ fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease. (NCT00552058)

UCB Cimzia Protocol C87088

A phase IIIB, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab’ fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s Disease who have participated in C87085. (NCT00552344)

Hutchison MediPharma HPML-004 Protocol 200500401

Double-Blind, Randomized, Multicenter, Placebo-Controlled Phase II Study of Efficacy and Safety of HPML-004 in Subjects with Active Moderate Crohn’s Disease. (NCT00655733)
 

Ulcerative Colitis

Abbott MO6-827

A Muliticenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. (NCT00408629)

Abbott M10-223

A Muliticenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis. (NCT00573794)

Bristol-Myers Squibb Protocol IM101-108

A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Ulcerative Colitis who have had an Inadequate Clinical Response and /or Intolerance to Medical Therapy. (NCT00410410)

Centocor Protocol C0524T17

A Phase 2/3 Multicenter, Randomized, Placebo Controlled, Double-Blind, Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis. (NCT00487539)

Centocor Protocol C0524T18

A Phase 3 Multicenter, Randomized, Placebo Controlled, Double-Blind, Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis. (NCT00488631)

Cosmo CB-01-02/01

Efficacy and safety of new oralbudesonide-MMX (CB-01-02) 6mg and 9mg extended release tablet formulations in patients with mild or moderate, active ulcerative colitis. A multicenter, randomized, double-blind, double-dummy comparative study versus placebo with an additional reference arm evaluating Asacol 2400mg. (NCT00679432)

Hollis-Eden HE3286-0301

A Phase I-II, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study of the Safety, Tolerance, Pharmicokinetics and Activity of HE3286 when administered orally to patients with active mild to moderate Ulcerative Colitis. (NCT00628433)

Hutchinson MediPharma HPML-004-US-02

A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis with or without Mesalamine. (NCT00659802)

Millennium Protocol C13006A (Gemini I)

A Phase III, Randomized, Placebo-Controlled, Double-Blind, Multicenter, Multiple Dose Study to Determine the Efficacy and Safety of MLN0002 for the Induction of Clinical Response and Remission in Patients with Moderate to Severe Ulcerative Colitis. (NCT00783718)

Millennium Protocol C13006B (Gemini I)

A Phase III, Randomized, Placebo-Controlled, Double-Blind, Multicenter, Multiple Dose Study to Determine the Efficacy and Safety of MLN0002 for the Maintenance of Clinical Response and Remission in Patients with Moderate to Severe Ulcerative Colitis. (NCT00783718)

Millennium Protocol C13008 (Gemini I)

A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease. (NCT00790933)

Shire Pharmaceutical DEAR Phase 4

Test Treat Strategy to Prevent Ulcerative Colitis Relapse (NCT00652145)
(Dose Escalation And Response: DEAR)
 

Diverticulitis

Procter and Gamble DIVA Protocol 2007020

A 52 Week, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study to Assess the Safety and Efficacy of a 12-Week Treatment of Acute Diverticulitis with Asacol 2.4 g/day (400mg Mesalamine Tablet), followed by a 9 Month Treatment-free Observation Period. (NCT00554099)
 

Irritable Bowel Syndrome

Salix Protocol RFIB3007

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Rifaxamin 550 mg in the Treatment of Subjects With Non-Constipation Irritable Bowel. (NCT00731679)
 

Ulcerative Proctitis or Proctosigmoiditis

Axcan Pharma CD-ME-CAPSITUP508-01

A double-blind, controlled, randomized, parallel group comparison Phase IIIA treatment investigation on the efficacy and safety of MAX002 suppository versus placebo, and active medicine in mild to moderate Ulcerative Proctitis. (NCT01016262)