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Ulcerative colitis (UC) is a chronic, progressive disease that affects nearly 1 million Americans. Up to one-third of patients with UC will require hospitalization for severe symptoms such as pain and bloody stools, often within the first year after diagnosis.

While new therapies have revolutionized the medical care available to patients, offering a greater possibility of achieving remission or reducing the need for surgical intervention, researchers still have not seen a significant improvement in disease outcomes among those with the most severe form of the disease.

In addition, medical providers still are not able to tailor care for UC patients by predicting at the outset who may develop acute progression of the disease or see few benefits from medical therapy, and therefore be able to benefit from early surgery.

Johns Hopkins University is conducting a study in which investigators will observe up to 300 patients with severe ulcerative colitis. This study will be the first of its kind in the United States, and will be a key resource for understanding the natural history, risk factors and optimal therapies for care of UC patients.

Investigators hope that this study will serve as a valuable resource for clinical trials of new therapies and innovative strategies.

Over one-third of patients with severe UC receive intravenous steroids, which is the basis for initial management of the disease. Infliximab and cyclosporine are the two most commonly used medical therapies for these patients. In two previous clinical trials, they have shown to be similarly effective in both the short and long term.

Up to a third of patients, however, do not respond to this treatment. This lack of response is not well understood and may be a result of different factors that may be both patient- and drug-related.

One of the factors contributing to the limited success in treating patients with severe UC is there haven’t been large clinical studies to understand why some don’t get better with IV medication.

Patients who have been hospitalized for acute severe ulcerative colitis will be invited to enroll in the study. Those who participate will be treated by their physician’s treatment plan.

Investigators expect that some participants will be treated with standard versus accelerated dosing of the drug infliximab, in addition to other treatment strategies.

Eligible patients must be between the ages of 18 and 80, and have been diagnosed with an active form of ulcerative colitis or inflammatory bowel disease. They must have been hospitalized and treated with intravenous corticosteroid therapy or medical rescue therapy.

For more information, contact Dr. Joanna Melia at jpeloqu2@jhmi.edu.