Inflammatory Bowel Disease (IBD)


If you have ANY questions or are interested in participating please feel free to call (734) 615-4843 or e-mail higginsSCteam@umich.edu. We hope to hear from you soon!


Crohn's Disease Treatment Studies

Celltrion

A randomized, double-blind, parallel-group, phase 3 study to demonstrate noninferiority in efficacy and to assess safety of CT-P13 compared to Remicade® in patients with active Crohn’s disease

Enrollment status: OPEN

Study Coordinator: Kelli Porzondek

Drug: CT-P13 (generic Remicade®)

This is a phase 3 study for patients with moderate to severely active Crohn’s disease to evaluate the  safety and effectiveness of CT-P13 (a generic form of Remicade®) versus Remicade®. Patients will be randomized to receive either CT-P13 or Remicade® (no placebo) at week 0. All patients will randomly be assigned to either continue on the original randomized drug for the entire study, or to switch therapies at week 30. Patients will be eligible to receive drug for up to 54 weeks.


Rifaximin RECD3125

A double-blind, placebo-controlled, parallel-group, multicenter, multiregional, one year study to assess the efficacy and safety of twice daily oral rifaximin delayed release tablets for induction of clinical remission with endoscopic response at 16 weeks followed by clinical and endoscopic remission at 52 weeks in subjects with active moderate Crohn's disease

Enrollment status: UPCOMING

Study Coordinator: Katy Weller

Drug: Rifaximin

This is a one year study to assess the efficacy and safety of twice daily oral rifaximin delayed-release (DR) tablets in subjects with active moderate Crohn's disease. Patients will be randomized in a 1:1 ratio at week 0 to either rifaximin DR tablets 800 mg twice daily or placebo. The treatment period will last up to 52 weeks and will assess clinical remission and endoscopic response.


SERENE CD

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

Enrollment status: OPEN

Study Coordinator: Karina Lizzi

Drug: HUMIRA®

This is a phase 3 study for subjects with moderately to severely active Crohn’s disease to evaluate the efficacy and safety of two HUMIRA® induction regimens followed by standard maintenance therapy with HUMIRA®. Patients are randomized in a 1:1 ratio to receive either the standard induction dose or the higher induction dose of HUMIRA® followed by HUMIRA® every other week for 12 weeks. All patients will then roll over into a maintenance phase and continue to receive HUMIRA® every other week for up to 40 weeks.


Tofacitinib for Crohn’s disease

A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s disease>

Enrollment status: OPEN

Study Coordinator: Kay Sauder, (734) 647-2564, higginsSCteam@umich.edu

Drug: Tofacitinib (CP-690,550) – oral medication

This is a phase 2b study of subjects with moderately to severely active Crohn’s disease. The medicine is a JAK inhibitor made by Pfizer. JAK inhibition is a novel approach for treating a variety of autoimmune and inflammatory diseases. JAK inhibitors interrupt signaling downstream of a multiplicity of cytokines, rather than blocking one cytokine at a time, as in case of anti-TNF or interleukin-6 blockers. It is taken in pill form.

The study lasts 8 weeks and involves a screening visit, a week 0/baseline appointment, follow-up visits at week 2, week 4, and week 7 to assess response to the medicine. Finally, at week 8 we will assess the subject’s eligibility to continue in the program. Those who complete the treatment period and meet the definition of clinical response or clinical remission will be eligible to enter a placebo-controlled maintenance study of 26 weeks and then the open-label extension study, meaning there is no placebo and you are guaranteed active drug.


Ulcerative Colitis Treatment Studies

Hickory

A phase 3, double blind, placebo-controlled multicenter study of the efficacy and safety of etrolizumab during induction and maintenance in ulcerative colitis who are refractory to or intolerant of TNF inhibitors

Enrollment Status: OPEN

Study Coordinator: Kay Sauder

Drug: Etrolizumab, anti-integrin β7 – subcutaneous injection (under the skin)

This is a phase 3 study for patients with moderate to severely active ulcerative colitis who have failed or been intolerant to Remicade® and/or adalimumab. The study medication, etrolizumab, contains a new class of molecules that target the β7 integrin receptor in the lining of the gut to regulate white blood cell trafficking.

The study lasts up to 66 weeks and involves a screening visit, baseline enrollment visit, and follow-up drug administration visits every 4 weeks. Patients are also required to have a colonoscopy done at screening, week 14, and week 66 in order to assess disease activity and response to study medication. Patients who enroll in the study will be randomly assigned to etrolizumab or placebo (inactive medication). All patients have a 20% chance of receiving placebo. After completing the Hickory study, patients have the option to roll over into the open-label portion of the study known as Cottonwood, and receive active study medication for up to 7 years or until the medication is approved by the FDA.


JNJ JAK

A phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-response study evaluating the efficacy and safety of JNJ-54781532 in subjects with moderately to severely active ulcerative colitis

Enrollment status: OPEN

Study Coordinator: Karina Lizzi

Drug: JNJ-54781532, oral medication

This is a phase 2b study for subjects with moderately to severely active ulcerative colitis. This medicine is a JAK inhibitor and is taken orally once or twice daily, depending on the treatment arm. Patients are randomized to 1 of 5 study arms: placebo, 25 mg once daily, 75 mg once daily, 150 mg once daily, or 75 mg twice daily and will be assessed for clinical response at week 8. Those on placebo who are not in clinical response at week 8 will begin treatment with JNJ-54781532 150 mg once daily. The study treatment period will last up to 32 weeks.


OCTAVE

A multicentre, randomized, double-blind, placebo-controlled, parallel group study of oral CP-690,550 (JAK inhibitor) as an induction therapy in subjects with moderate to severe ulcerative colitis

Enrollment Status: OPEN

Study Coordinator: Kay Sauder

Drug: Tofacitinib (CP-690,550) – oral medication

This is a phase 3 study of subjects with moderately to severely active ulcerative colitis. The medicine is a JAK inhibitor made by Pfizer. JAK inhibition is a novel approach for treating a variety of autoimmune and inflammatory diseases. JAK inhibitors interrupt signaling downstream of a multiplicity of cytokines, rather than blocking one cytokine at a time, as occurs with anti-TNF or interleukin-6 blockers. It is taken in pill form.

The study lasts 9 weeks and involves a screening visit, a week 0/baseline appointment, and follow-up visits at week 2, week 4, and week 8 to assess response to the medicine. Finally, at week 9 we will assess the subject's eligibility to continue in the program. Those who complete the treatment period and meet the definition of clinical response or clinical remission will be eligible to enter a placebo-controlled maintenance study of 52 weeks (A3921096). Subjects who complete the treatment period but do not meet the definition of clinical response or remission will be eligible to enter an open-label extension study (A3921139), meaning there is no placebo and you are guaranteed active drug.


SERENE

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

Enrollment status: OPEN

Study Coordinator: Karina Lizzi

Drug: HUMIRA®

This is a phase 3 study for subjects with moderately to severely active ulcerative colitis to evaluate a high-dose HUMIRA® induction regimen versus a standard-dose induction regimen, followed by high-dose versus standard-dose maintenance therapy. Patients will be randomized in a 1:1 ratio to receive a standard- versus high-induction dose over an 8-week period. At week 8, patients are re-randomized to receive maintenance dosing at 40 mg every week or 40 mg every 2 weeks. The treatment period will last up to 44 weeks.


Ulcerative Colitis and Crohn’s Disease Observational Studies

CCFA CDI

Clostridium difficile infection (CDI) induces changes in the gut microbiome that lead to ulcerative colitis flares

Enrollment Status: OPEN

Study Coordinator: Katy Weller

The long-term goal of this project is to identify what causes flares of ulcerative colitis (UC). Patients with UC can stay in remission for months or years, but the threat of a flare of disease is always present. We have little understanding of what actually triggers flares of UC, and few opportunities to study flares before they start. Several recent studies have elucidated the role of Clostridium difficile infection (CDI) in triggering flares in patients with UC, leading to extended hospital stays, more severe disease, and a high rate of colectomy. This is a prospective cohort study with longitudinal sampling of stool microbiome from UC patients with CDI, non-IBD patients with CDI, and UC patients with non-CDI flares.

We will use deep microbial 454 sequencing to determine whether specific changes in the gut microbiome in UC patients infected with Clostridium difficile are predictive of two adverse clinical outcomes in UC patients: UC flares induced by C. difficile infection, and recurrence of C. difficile infection.


GEM Project

A multidisciplinary human study on the genetic, environmental and microbial interactions that cause inflammatory bowel disease

Enrollment Status: OPEN

Study Coordinator: Kay Sauder

This study is for healthy first degree relatives of patients with Crohn’s and it is funded by the Crohn’s and Colitis Foundation of Canada (CCFC). Healthy volunteer participation includes one visit with a blood, stool, and urine sample, and a few surveys. A research team member will call the volunteer once every 6 months for the next 5 years to see if any new IBD symptoms have occurred.


Legacy

A long-term non-interventional registry to assess safety and effectiveness of HUMIRA® (adalimumab) in patients with moderately to severely active ulcerative colitis (UC)

Enrollment Status: OPEN

Study Coordinator: Anna Romans

The purpose of this research study is to collect long-term safety information on HUMIRA® (adalimumab), a monoclonal antibody approved for the treatment of moderate to severely active ulcerative colitis (UC). Information will also be collected if subjects are using one of the two immunomodulator medications, azathioprine (AZA), and 6-mercaptopurine (6-MP).


Lycera

Inflammatory bowel disease (IBD) Lycera serum study

Enrollment Status: OPEN

Study Coordinator: Kelli Porzondek

This is an exploratory study to test a novel biologic compound targeting circulating active T-cells on a blood sample from subjects with inflammatory bowel disease (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC). This study is based on preliminary data obtained by researchers in Italy showing that some activated T cells can be specifically killed by new drugs. We will explore the mechanism of action and basis for selectivity in this subset of cells for biomarker development. This study involves only a single blood draw.


Novel biomarkers of intestinal fibrosis in Crohn's disease

Enrollment Status: OPEN

Study Coordinator: Kelli Porzondek

The hypothesis of this study is to determine if blood-based biomarkers of intestine-specific fibrogenesis and fibrosis will identify and quantify fibrostenotic intestinal damage, providing prognostic value for complications of Crohn's disease. The specific aims of this study are three-fold: to determine if levels of novel markers of intestinal inflammation discovered by proteomic analysis correlate with the presence and burden of fibrostenotic disease in patients with Crohn's disease; to determine if identified biomarkers of fibrosis predict the long-term development of fibrosis and recurrent intestinal fibrostenotic disease in post-operative patients; and finally, to determine if identified biomarkers of intestinal inflammation provide unique prognostic and predictive disease monitoring information compared to other biomarkers of disease activity including erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), fecal calprotectin, and lactoferrin. Patients with Crohn's disease who have active disease, intestinal narrowing, and who are scheduled for surgical resection will be recruited for this study.