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 21201.
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 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 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 at 22 S Greene St, Baltimore, MD 21201.
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/NCT00790933?term=vedolizumab&rank=2.
The purpose of this study is to evaluate whether the combination of oral budesonide and rectal hydrocortisone is effective in the treatment of patients with moderately active ulcerative colitis (UC). In addition, the study will evaluate whether the combination of oral budesonide and rectal hydrocortisone 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 hydrocortisone for eight weeks. The budesonide and hydrocortisone will be tapered 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 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 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, see http://clinicaltrials.gov/ct2/show/NCT00524537?term=adalimumab&rank=3 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, see http://clinicaltrials.gov/ct2/show/NCT00707512?term=inform&rank=2 or contact Ankur Rustgi at 410-706-3397.
We are also actively involved in a number of other research projects including but not limited to:
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