A Member of the University of Maryland Medical System | In Partnership with the University of Maryland School of Medicine
Physicians in the University of Maryland Medical Center's Inflammatory Bowel Disease (IBD) Program are actively involved in clinical research. For more information about current clinical trials or past publications, please click on the links below.
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 use of an experimental drug, MLN002 is safe in participants suffering from moderate to severe Crohn's disease refractory to medical therapy. Enrolled participants will receive 300 mg MLN0002 or placebo at weeks 0, 2 and 6. Responders to treatment will then receive either placebo or MLN002 every 4 to 8 weeks for up to one year. Safety assessments and efficacy assessments will be made throughout the treatment period.
To be eligible for the study, participants cannot have been treated with anti-TNF agents such as Remicade, Humira or Cimzia in the past.
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 Crohn's disease, 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 21201.
If you are interested in participating in the study, please call the study coordinator Nadia Cheevers at 410-706-3398, or the Principal Investigator Raymond K. Cross, M.D., M.S. at 410-706-3387. For more information, please click here.
The clinical trial will test to see if the long term use of experimental drug, MLN002 is safe in participants suffering from ulcerative colitis or Crohn's disease who have been taking MLN002 without any major adverse events. Enrolled participants will receive 300 mg MLN0002 every 4 weeks, starting at Week 0, for up to 100 weeks. The dosing period will be followed by a 16-week post-treatment observation and safety assessment period. Safety assessments and efficacy assessments will be made throughout the treatment period.
To be eligible for the study, participants must have received previous treatment in Study C13006 or 13007 that, in the opinion of the investigator, was well tolerated.
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, located at 22 S Greene St, Baltimore, MD 21201.
If you are interested in participating in the study, please call the study coordinator Nadia Cheevers at 410-706-3398, or the Principal Investigator Raymond K. Cross M.D., M.S., at 410-706-3387. For more information, please click here.
The proposed study will test whether surgically established drainage prior to medical therapy improves outcomes in 80 patients with Crohn's perianal fistulas. Patients will be randomized to receive surgical drainage prior to initiation of therapy or medical therapy without drainage. Patients are required to have a colonoscopy within 6 months of beginning the study. Patients will also undergo a physical exam and either a transrectal ultrasound or a pelvic MRI. Most patients will undergo a colonoscopy at baseline as well. All patients will be treated with a combination of antibiotics, immune suppressants (6-MP, azathioprine, or methotrexate, and certolizumab (Cimzia)). Surgical drainage will be performed at the University of Maryland Medical Center. Patients will be reevaluated every 8 weeks for one year. Patients randomized to surgical drainage plus medical therapies are eligible to have the surgical drains removed after 20 weeks. All participants undergo a repeat transrectal ultrasound or pelvic MRI at one year.
For further information, please click here, or call Ankur Rustgi at 410-706-3397, or the principal investigator Leyla Ghazi, M.D., at 410-706-3387.
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, please click here, or call Ankur Rustgi at 410-706-3397.
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, please click here, or contact Ankur Rustgi at 410-706-3397.
The proposed study will evaluate the safety of natalizumab (Tysabri) in patients with moderately to severely active CD already receiving Tysabri as part of their medical treatment. Investigators will collect safety and efficacy data as well as blood over time in patients treated with Tysabri. This will assist in the clarification of the short and long-term safety profile of this medication. For more information, please click here, or contact Ankur Rustgi at 410-706-3397.
The proposed study will evaluate the safety of certolizumab (Cimzia) in patients with Crohn's disease already receiving Cimzia as part of their medical treatment compared to control patients not receiving Cimzia. Investigators will collect safety and efficacy data over time in patients treated with Cimzia. This will assist in the clarification of the short and long-term safety profile of this medication.
For more information, please click here, or contact Ankur Rustgi at 410-706-3397.
The proposed study will evaluate the impact of inflammatory bowel diseases on body composition and functional performance. Young (less than 45 years old) and older patients (60 years and older) are eligible to participate. Young and older patients with IBD will complete questionnaires regarding fatigue, diet, and physical activity, diagnostic tests including a fasting blood glucose, cholesterol, CT scan of the thigh, total body densitometry (which measures bone, muscle and fat mass), exercise stress test, a maximal exercise test, and strength and dexterity testing. Older participants are eligible after baseline testing to receive resistance or aerobic exercise testing under the supervision of an exercise physiologist three times per week for three months. Older participants undergo a repeat CT scan, densitometry, strength testing, and exercise testing after the 3 month training period.
For more information, contact Nadia Cheevers, R.N., B.S.N., or Sandra Quezada, M.D., M.S., at 410-706-3398. You may also contact the principal investigator Raymond K. Cross, M.D., M.S., at 410-706-3387.
We are also actively involved in a number of other research projects, including but not limited to:
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