The University of Maryland Inflammatory Bowel Disease Program is actively involved in clinical research. The UMB IBD program is a member of the Clinical Research Alliance of the Crohn's and Colitis Foundation of America. Currently, the UM IBD program offers the following clinical research studies for patients to participate in:
The clinical trial will test to see if the experimental drug, MLN002 is effective in participants suffering from ulcerative colitis who have not responded to standard medications. Enrolled participants will receive either the study drug or placebo for 6-weeks. The selection of study drug or placebo will be decided by a randomization (“coin flip”). The patient, medical provider and research team will not know what group you have been assigned to. During the first 6 weeks, participants will be seen at baseline and then every 2 weeks. Responders to treatment will then receive either study drug or placebo for another 46 weeks. Non-responders after 6 weeks will receive study drug. Infusions of the study drug or the placebo and study visits will occur every 4 weeks during the second phase of the study. After 52 weeks, all participants will be eligible to receive study drug in a separate trial called C13008.
To be eligible for the study, participants must have ulcerative colitis for 6 months, must be older than 18 and must have tried and failed at least one form of standard ulcerative colitis therapy.
During the study, participants may suffer side effects from the study drug MLN0002 and the study procedures. The most commonly reported side effects by participants on the study drug in previous studies were headache, nausea, worsening of the ulcerative colitis, abdominal pain, fatigue, allergic reactions, and upper respiratory infections. Participants will be closely monitored during the study for any side effects. If any undesirable effects occur, the study doctor will decide if the study drug should be stopped.
Most of the costs of study related procedures will be paid for by the sponsor. Study drug will be provided without cost to the participant. Participants will be compensated for parking, gas and for their time at each study related visit. All the research related activities will be performed at the University of Maryland Medical center at 22 S Greene St, Baltimore, MD 21209.
If you are interested in participating in the study, please call the study coordinator Ankur Rustgi at 410-706-3397 or the Principal Investigator Raymond K Cross MD MS at 410-706-3387. For more information, go to http://clinicaltrials.gov/ct2/show/NCT00783718?term=vedolizumab&rank=3.
The purpose of this study is to evaluate whether the combination of oral and rectal budesonide is effective in the treatment of patients with moderately active ulcerative colitis (UC). In addition, the study will evaluate whether the combination of oral and rectal budesonide is better tolerated than conventional steroids. Twenty patients will be recruited in this open label study. All eligible patients will receive a combination of oral budesonide and rectal budesonide for eight weeks. Both forms of budesonide will be tapered according to the investigators preference after week 8. Clinical visits will take place at baseline and 8 weeks. In addition, telephone follow up will take place at weeks 2, 4, 6, 10, 12, 26, and 52. Assessment of efficacy and safety will take place at the follow up clinic visit and at each telephone follow up.
For more information, see trials.gov or call Nadia Cheevers at 410-706-3398.
The purpose of the study is to determine if a home telemanagement system for patients with ulcerative colitis (UC HAT) improves clinical outcomes compared to routine care. Patients with UC will be identified from the University of Maryland IBD program and the gastroenterology clinic of the VA Maryland Health Care System, Baltimore.
A computer program will assign interested patients by chance to either the UC HAT or the routine care group. Patients in the UC HAT group will be asked to complete self-testing each week at home using the system. The home-unit consists of a laptop computer and electronic weight scale. After turning on the computer, patients answer questions about their bowel symptoms, medication side effects, and compliance with medications. The home-unit then prompts subjects to measure their weight on the scale. Subjects then receive an educational "tip of the day." The following session, subjects answer an educational question that relates to the tip.
After self-testing is completed, the results are transmitted via a phone line to our secure server. The results are made available immediately for review on the physician's web portal. Based on the responses to the symptom diary, side effect questions, medical compliance, and body weight, electronic alerts and action plans can be generated. An alert is sent electronically to the study coordinator, who then reviews the information and discusses the findings with the principal investigator and the patient's medical provider.
Changes in patient management can be made if appropriate. An action plan is created for each patient at the first visit and contains a list of tasks for patients to start immediately after self-testing if certain criteria are met. Patients still undergo regularly scheduled clinical visits as prescribed by their medical provider.
Patients assigned to the routine care group will undergo scheduled follow up clinical visits, telephone follow up, and receive educational fact sheets about their disease. This is considered routine care at our centers. All patients will undergo research visits every 4 months for one year. Patients will complete a series of questionnaires at each visit that measure the patient's disease activity, quality of life, IBD knowledge, medical compliance, and other parameters. Emergency room visits and hospitalizations will also be measured. A blood draw is required at each study visit.
We think that UC HAT will improve the monitoring of bowel symptoms and medication side effects and improve medical compliance. These improvements should result in decreased bowel symptoms, improved quality of life, and decreased urgent care visits and hospitalizations. If UC HAT is effective, the system could be used in the IBD community to improve clinical care or be used in patients with limited access to health care.
For further information, see http://clinicaltrials.gov/ct2/show/NCT00620126?term=telemanagement&rank=1 or call Nadia Cheevers at 410-706-3398.
The proposed study will test whether increasing Lialda dose can reduce fecal calprotectin (FCP) levels, a marker of intestinal inflammation that is highly predictive of the risk of relapse among patients with inactive ulcerative colitis. Sixty patients with FCP levels <50mcg/gm stool will be observed for 48 weeks. All patients will have FCP concentration measured using a commercially available assay at enrollment, 6 weeks and 12 weeks. All patients with persistently elevated FCP will receive one or both of the following interventions: change in the mesalamine formulation to Lialda and/or increase in the dose of Lialda. Reduction in FCP levels below 50mcg/gm stool 6 weeks after randomization will be the primary outcome. The percentage of patients achieving this outcome will then be compared between groups. All randomized patients (as well as those who were excluded from the trial because of a low FCP concentration at baseline) will be followed to week 48 to determine the rate of clinical relapse.
For further information, see http://clinicaltrials.gov/ct2/show/NCT00652145?term=lialda+and+relapse&rank=1 or call Lee Ann Pazulski at 410-706-4310.
The proposed study will evaluate the safety of Humira (Adalimumab) in patients with moderately to severely active CD already receiving Humira as part of their medical treatment. Investigators will collect safety data over time in patients treated with Humira. This will assist in the clarification of the short and long-term safety profile of this medication. For more information, contact Lee Ann Pazulski at 410-706-4310.
We are also actively involved in disparities research in patients with Crohn's disease and ulcerative colitis. We have found differences between Caucasians and African American in the extent of disease, disease severity, and use of medications for treatment. We are planning to evaluate whether differences exist in care by race and to explore reasons for any possible disparities using a national sample of Veteran patients. We are also interested in physician performance measures; we have a study in preparation that evaluates physician compliance with infliximab prescribing guidelines.
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