Checkup

People with Crohn's disease
Sought to Test New Medication

Mayo Clinic physicians are participating in a research study of an investigational medication to see if it safely and effectively helps control Crohn's disease.

The purpose of this study is to evaluate the effectiveness of a drug called sargramostim in patients with active Crohn's disease. The drug includes a protein molecule that helps fight inflammation and stimulate components of the immune system. It works like most current Crohn's disease therapies, but may represent a different and unique mode of action for treatment of the disease.

The study will involve approximately 330 patients at 100 sites nationwide. It is a 6-part trial which consists of a 1-3 week screening period, 8 weeks of drug treatment, a treatment-free observation period and a randomized 8-week treatment course where patients will either receive sargramostim or placebo. The drug is self-administered daily by injection. Patients who do not respond to sargramostim will be discontinued from the study after the first 8 weeks. All patients will be followed from 1 to 7 months after their last dose of study drug depending on their response.

Eligible patients will receive study-related medical care and the medication at no charge. At the conclusion of the study, and depending on their response to the drug, patients may be eligible to enroll in another trial where all participants will receive sargramostim at no charge for an additional year.

To be considered, people must be over 18 years old with active Crohn's disease. For more information, contact Verna Skinner in the Clinical Studies Unit at (904) 953-6898.

Learn more about the treatment of Crohn's disease at Mayo Clinic Jacksonville.