Inflammatory Bowel Disease (IBD)
If you are interested in participating in a study, please contact one of our Clinical Subjects Coordinators.
Contact for Dr. Higgins' Studies
Carrie L. Bergmans
Phone: (734) 615-2457 Fax: (734) 763-2535 E-mail: bergmans@med.umich.edu
Rebecca Cleeton
Phone: (734) 615-4843 Fax: (734) 763-2535 E-mail: cleetonr@med.umich.edu
Contact for Dr. Zimmermann's Studies
Karla Helvie
Phone: (734) 615-7977 Fax: (734) 763-2535 E-mail: khelvie@med.umich.edu
Crohn's Disease Treatment Studies
Crohn's Disease Post Surgery Study
Crohn's Disease & Ulcerative Colitis Surgery Study
Crohn's Disease Imaging Studies
Crohn's Disease Registry Studies
Ulcerative Colitis & Crohn's Disease Observational Studies
Upcoming Studies
Contact Us
Crohn's Disease Treatment Studies
A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of GSK 1605786A in the treatment of subjects with moderately to severely active Crohn's disease
Principal Investigator: Peter Higgins, MD, PhD, MSc
This study will assess the effectiveness of a new compound, GSK1605786A, taken orally, compared to placebo as an induction therapy for Crohn’s patients over 12 weeks. This is an orally administered chemokine antagonist that specifically blocks the migration of gut-specific T cells, which selectively home to the intestine.
Subjects 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. 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. This study will be sponsored by GlaxoSmithKline.
A phase 3, randomized, placebo-controlled, blinded, multicenter study for the induction of clinical response and remission by vedolizumab in patients with moderate to severe Crohn's disease (Gemini)
Principal Investigator: Peter Higgins, MD, PhD, MSc
This study will assess the effectiveness of a new monoclonal antibody, compared to placebo, as an induction therapy for Crohn’s patients who have failed anti-TNFα therapy. Vedolizumab binds to the α4β7 integrin, which is expressed on discrete populations of leukocytes involved in gut mucosal immunity. Vedolizumab antagonizes both the α4β7-MAdCAM-1 interaction and the associated migration of leukocytes into GI mucosa. This mechanism of action of vedolizumab reduces pathological bowel inflammation, thus providing a potential therapeutic option for patients with CD.
There will be an induction study, followed by an open-label long-term phase 3 safety study in which study subjects will have access to study drug for an additional 2 years.
Crohn's Disease Post Surgery Study
Trial comparing Remicade® and placebo in the prevention of relapse in Crohn's disease patients undergoing surgical resection (PREVENT Study)
Principal Investigator: Peter Higgins, MD, PhD, MScThis study will test whether an FDA-approved anti-TNF antibody, Remicade®, after surgery for Crohn's disease can prevent recurrence of disease symptoms. Eligible patients may be able to enroll in maintenance and extension phases that can provide medication for up to 4 years. Patients must be undergoing an ileocolonic surgical resection (i.e., an intestinal resection with an ileocolonic anastomosis) AND at higher risk of developing recurrence by meeting at least ONE of the following criteria:
- The qualifying surgery is being performed for a penetrating complication of CD
- The qualifying surgery is the second (or more) intra-abdominal operation for CD in the past 10 years
- The qualifying surgery is the patient’s third (or more) intra-abdominal operation for CD
Crohn's Disease & Ulcerative Colitis Surgery Study
Novel biomarkers of intestinal inflammation and fibrosis in Crohn’s disease
Principal Investigator: Peter Higgins, MD, PhD, MSc
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.
Crohn's Disease Imaging Studies
A prospective evaluation of computed tomography enterography (CTE) in assessing Crohn’s disease activity
Prinicipal Investigator: Ellen Zimmermann, MD
The main purpose of this 3-year study is to find out if there is a relation between computed tomography enterography (CTE) and magnetic resonance enterography (MRE) findings and clinical assessments in patients with Crohn’s disease. Each patient will have 3 scans at 1-year intervals, and the patient’s Crohn’s Disease Activity Index (CDAI) will be calculated for the 7 days prior to each scan and certain laboratory values, erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), will be obtained close to the scan date. This study will help to better define the role of CTE and MRE in evaluating Crohn’s disease.
Magnetization transfer magnetic resonance imaging (MT-MRI) as a non-invasive method of assessing fibrotic intestinal strictures in Crohn’s disease
Principal Investigator: Ellen Zimmermann, MD
The purpose of this study is to test whether a specific imaging sequence used during an MRI scan, called an MT-MRI, could be used as a non-invasive method for differentiating between fibrotic (scarring) and inflammatory intestinal strictures in Crohn's disease. Being able to detect the difference between fibrosis and inflammation would lead to better knowledge of how to treat that patient. Having a non-invasive means of monitoring disease progression and development of fibrosis would be useful in determining when patients would benefit from starting different therapies, so as to decrease or prevent permanent intestinal fibrosis without unduly exposing patients to side effects of serious medications.
Crohn's Disease Registry Studies
Cimzia® Registry
Principal Investigator: Ellen Zimmermann, MD
This is a registry study to collect information on the long-term use and safety of Cimzia® as compared to other Crohn's disease medications prescribed by your doctor in routine clinical practice. Patients enrolled in this study will complete surveys about their social and medical history. Additionally, at your regularly scheduled office visits, you will be asked to provide information regarding your Crohn's disease symptoms and other relevant information about your health and medications. UCB, Inc. is the sponsor for this study. Patients who have been prescribed Cimzia® by their physician to treat Crohn's disease are able to participate in this study.
Tysabri® Registry
Principal Investigator: Ellen Zimmermann, MD
This is a registry study to collect information on the long-term use and safety of Tysabri® as compared to other Crohn's disease medications prescribed by your doctor in routine clinical practice. Elan Pharmaceuticals is the sponsor of this study. Eligible patients are those who have been prescribed Tysabri® by their physician for the treatment of Crohn's disease.
Ulcerative Colitis & Crohn's Disease Observational Studies
Predictive value of fecal calprotectin measurement in severe UC
Principal Investigators: Peter Higgins, MD, PhD, MSc and Ryan Stidham, MD
This two-center prospective study will study if the measurements of fecal calprotectin (FCP) performed serially during admission in patients with severe ulcerative colitis (UC) may be predictive of need to escalate medical therapy. Additionally, this study will investigate if using FCP can predict outcomes of interest, including readmission, surgery, and Clostridium difficile infection at 30 and 100 days.
Fecal calprotectin as a predictor of treatment failure during IBD steroid taper
Principal Investigators: Peter Higgins, MD, PhD, MSc and Ryan Stidham, MD
This study is designed to evaluate if calprotectin levels during a steroid taper in an IBD patient are predictive of future failure of the steroid taper.
BÜHLMANN calprotectin ELISA method comparison to predictive device for FDA clearance
Principal Investigator: Peter Higgins, MD, PhD, MSc
An instrument was developed by BÜHLMANN to test calprotectin levels in stool specimens in Europe, however it is not approved by the FDA for use in the United States. This instrument would aid in the diagnosis of inflammatory bowel diseases (IBD), as well as aid in the differentiation of active versus inactive inflammation of IBD, irritable bowel syndrome (IBS), and other functional bowel syndromes.
Inflammatory Bowel Disease (IBD) Databank
Principal Investigator: Ellen Zimmermann, MD
In this study we collect information on patients with IBD and their family. We are interested in the demographics, genetics, and extent of disease at this time. Participants in this study give a blood sample for genetic analysis and take surveys bi-annually. In the future, we plan to collect tissue or stool samples as part of this study to learn more about how the immune system works in people with IBD. The duration of this study is open-ended. Adults with IBD and their family are welcome to participate.
The effect of IBD on students' adjustment to college
Principal Investigator: Ellen Zimmermann, MD
This study is meant to investigate the effect of inflammatory bowel disease (IBD) on how well college students adjust to their new environment. We have developed a web site where college students can take a survey aimed at examining these differences. Living with a chronic disease is difficult enough without the added challenges that come with transitioning to college life. It has been previously shown that successful adjustment to college is critical for success in academics and later in life. We would like to help inform the development of more effective interventions for students with IBD to facilitate their transition to college. Undergraduate students enrolled at a 4-year residential college or university in the United States, who are 17+ years old with IBD, or without any chronic illnesses, are able to participate in this study.
Upcoming Studies
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 Crohn’s disease who have failed or are intolerant to TNF antagonist therapy
Principal Investigator: Peter Higgins, MD, PhD, MSc
Ustekinumab showed promising efficacy in Centocor’s Phase 2a study (C0379T07) in patients who had failed conventional Crohn’s disease therapy (Sandborn et al, 2008) and in Centocor’s positive Phase 2b study (C0743T26) of ustekinumab in Crohn’s disease patients who had failed or were intolerant to TNF antagonist therapy. This is the next study of this series, which will evaluate the efficacy of IV induction regimens of ustekinumab in inducing clinical response in subjects with moderately to severely active Crohn’s disease who have failed or are intolerant to one or more TNF antagonist therapies.
A phase IIb randomized, placebo-controlled study to evaluate the clinical efficacy and safety of induction and maintenance therapy with BMS-936557 in subjects with active ulcerative colitis (UC)
Principal Investigator: Peter Higgins, MD, PhD, MSc
This study will compare the efficacy of BMS-936557 (IV administered drug) vs placebo for induction of clinical remission in UC patients with a clinical diagnosis of moderate to severely active UC confirmed by endoscopic evidence. A maintenance and open-label study will also be offered to these patients.
Phase II randomized double-blind placebo-controlled study to evaluate the efficacy and safety of rhuMAb beta7 in patients with moderate to severe ulcerative colitis
Principal Investigator: Peter Higgins, MD, PhD, MSc
The primary objective of this study is to evaluate the efficacy of different doses of rhuMAb Beta7 compared with placebo in patients with moderate to severe UC. rhuMAb Beta7 is a humanized IgG1 monoclonal antibody targeting the b7 subunit of the a4b7 and aEb7 integrin heterodimer receptors.
Patients included in the Phase II study will have failed conventional therapy and will receive a background of concomitant medication for the treatment of UC that includes oral and/or topical 5-aminosalicylic acid (5-ASA), oral and/or topical corticosteroids, immunosuppressant agents in the form of azathioprine (AZA), 6-mercaptopurine (6‑MP), or methotrexate. Patients who are biologic treatment naive will be included as well as those who are known to have failed to respond to biologics after the appropriate washout period.
CADHUM calprotectin-directed Humira® maintenance therapy, a double-blind. double-dummy, randomized trial in Crohn's disease
Principal Investigator: Peter Higgins, MD, PhD, MSc
This study has been proposed by the study team to Abbott Laboratories to determine whether Crohn’s patients in remission, with a fecal calprotectin <167, can safely stop Humira® therapy for up to 48 weeks, and if this state can be safely monitored with biomarkers of inflammation with no further therapy. If and when elevations in biologic biomarkers occur, Humira® therapy will be restarted as needed.
