If you are interested in participating in a study, please contact one of our Clinical Subjects Coordinators.
Carrie L. Bergmans
Phone: (734) 615-4843 E-mail: higginsSCteam@med.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
Stelara is a medicine that blocks the activity of a protein in your body called interleukin 12/23. This protein is thought to be important in causing inflammation and therefore may play a major role in diseases like Crohn's disease and ulcerative colitis. It has already been tested and approved to treat psoriasis and psoriatic arthritis. Stelara showed promising results in previous phase II studies of patients with Crohn's disease who had not done well while taking medicines available on the market. This study, which is the next one in the series, will evaluate the effectiveness of IV infusion (given through a vein) and/or injection (given under the skin) doses of Stelara in helping to reduce symptoms in patients with moderately to severely active Crohn's disease.
Appointments are at screening, week 0 (IV infusion), week 3, week 6, and week 8. If you complete this 8-week study, you will have the option to join the maintenance phase of the study, which will allow access to the drug for up to 4 years. This will involve returning to the site every 4 weeks for an injection under the skin. You will be reimbursed $50 for each completed appointment.
Principal Investigator: Peter Higgins, MD, PhD, MSc
Enrollment Status: OPEN
Drug: Trichuris suis ova (TSO) – oral medicine
The University of Michigan is looking for people with Crohn's disease to participate in a clinical research study examining a new type of probiotic. Highly clean environments in developed countries reduce exposure to germs and parasites. Some scientists think this lack of exposure may trigger responses in the body that make people more susceptible to diseases in which a person's immune system could cause damage to its own tissues and internal organs (e.g.,Crohn's disease). People in nonindustrial countries and the tropics where parasites are common rarely develop this type of disease.
This study is evaluating an investigational biological study product that is a new approach to treating Crohn's disease based on the ideas above. This study will examine the safety, effectiveness, and tolerability of Trichuris suis ova (TSO), a type of probiotic, compared to placebo in people who have Crohn's disease. TSO are the eggs of a very small worm called a "helminth." TSO were chosen because they are not a human parasite, and can't live for more than a few weeks in your body. After being swallowed, TSO’s temporary presence in the gut causes a reaction from your immune system. The researchers doing this study think that the TSO may "distract" your body so that it fights the worm and possibly won't "attack" the person's body anymore. Early clinical trials show that TSO may be effective in treating active Crohn's disease.
Appointments are at screening, screening colonoscopy, week 0, week 2, and every 2 weeks from there on, for 24 weeks. If you complete all visits, you will receive up to $1,385.00 compensation for your time and travel.
Principal Investigator: Peter Higgins, MD, PhD, MSc
Enrollment Status: OPEN
Drug: MEDI-2070 – intravenous (IV) infusion and injection under the skin
The PEBBLE Program is a clinical research study being conducted worldwide to test the effectiveness of MEDI-2070 in people who have Crohn's disease. MEDI-2070 blocks a type of protein called interleukin-23 (IL-23). This protein is thought to be important in causing inflammation and therefore may play a major role in Crohn's disease. A recent study showed that MEDI2070 helps patients with a skin disease called psoriasis, another disease where IL-23 is thought to play a major role. MEDI2070 may help decrease inflammation in the gastrointestinal tract of patients with Crohn's disease.
If you decide to take part, you will first complete the induction phase. For this, you will be asked to visit the study center 6 times over the 12-week study period. At weeks 0, 2, 4, 8, and 12, you will return to the site to complete a routine check-up and receive a dose of the study medicine in an IV (week 0 and 4 only). This will include collection of laboratory tests (blood, urine, and stool), a weight check, and a physical examination. On some occasions you may also need to complete forms or questionnaires.
If you complete this study, you will have the option to join the open-label phase of the study, which will allow access to the drug for up to 2 years. This will involve returning to the site every 4 weeks for an injection under the skin. There is no placebo involved in this portion of the study. You will be reimbursed $90 for each visit completed.
Principal Investigator: Peter Higgins, MD, PhD, MSc
Enrollment status: OPEN
This study will determine if 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.
Principal Investigator: Peter Higgins, MD, PhD, MSc
Enrollment Status: CLOSED
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 lasting 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 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.
Principal Investigator: Peter Higgins, MD, PhD, MSc
Enrollment Status: OPEN
Drug:PF-00547659 – injection under the skin
The TURANDOT Program is a clinical research study being conducted worldwide to test the effectiveness of PF-00547659 in treating ulcerative colitis (UC). PF-00547659 is being studied because it may decrease the inflammation and ulceration of UC by decreasing the attraction of white blood cells to the intestines and preventing the wearing away of healthy tissue in the colon.
If you decide to take part, you will first complete the induction phase. For this phase you will be asked to visit the study center 6 times over the 12-week study period. You will be asked to return to the site for these visits to complete a routine check-up and receive a dose of the study medicine, which will be an injection under the skin. Your visits will likely include laboratory tests (blood, urine, and stool), a weight check, and a physical examination. On some occasions, you may also need to complete forms or questionnaires.
If you complete this study, you will have the option to join the open-label phase of the study, which will allow access to the drug for up to 2 years. This will involve returning to the site every 4 weeks for an injection under the skin. There is no placebo involved in this portion of the study. You will be reimbursed $90 for each visit completed.
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 is assessing 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. In addition, our study team will monitor the participant's 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 CD 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 CD 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 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.