If you are interested in participating in a study, please contact one of our Clinical Subjects Coordinators.
Carrie L. Bergmans
Phone: (734) 615-2457 E-mail: higginsSCteam@umich.edu
Karla Helvie
Phone: (734) 615-7977 E-mail: khelvie@med.umich.edu
Principal Investigator: Peter Higgins, MD, PhD, MSc
Enrollment Status: OPEN
Drug: Ustekinumab (Stelara®) – intravenous (IV) infusion and subcutaneous (SC) injection
Ustekinumab is a fully humanized monoclonal antibody that blocks activity of interleukin 12/23. It is approved in psoriasis and psoriatic arthritis (brand name Stelara). 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 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.
Appointments are at screening, week 0 (drug administration via IV infusion over 1 hour), week 3, week 6, and week 8. At the week 8 appointment, subjects have the option to enter the maintenance study (IMUNITI) in which they will be re-randomized and given the study drug every 4 weeks, for up to 4 years.
Principal Investigator: Peter Higgins, MD, PhD, MSc
Enrollment Status: OPEN
Drug: GSK 1605786A – oral medication
This study will assess the effectiveness of a new compound, GSK1605786A, 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 will return every 2 weeks over the 12-week treatment period. Every other visit is simply a blood draw to monitor drug response. 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 (CCX115157). 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 (CCX114644), where they will be given the study drug for 2 years.
Principal Investigator: Peter Higgins, MD, PhD, MSc
Enrollment Status: OPEN
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 in case of 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, 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.
Principal Investigator: Peter Higgins, MD, PhD, MSc
Enrollment Status: OPEN
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.
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.
Principal Investigator: Peter Higgins, MD, PhD, MSc
This study looks to assess MRE as an alternative imaging method for the assessment of inflammatory status in patients with Crohn's disease. If it is determined that a patient is eligible to participate in this study, they will visit the University of Michigan multiple times over the course of 4 weeks. They will undergo one ileocolonoscopy within the first 2 weeks and two MREs over the course of the second 2 weeks. Additionally, our study team will monitor their physical condition by performing various tests, such as vital sign measurements, physical examinations, and blood draws.
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.
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.
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.
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.
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.
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.