NCT00206700

Who might be able to join this trial:

• You are able to give your consent to take part in the study
• You took part in a previous study of the drug sargramostim for Crohn's disease within the last 12 months
• If your previous study did not allow steroid use: you currently have moderately to severely active Crohn's disease (based on a specific scoring system used by doctors), and if you are taking steroids, you are on a dose that can be gradually reduced to a low level within one treatment cycle
• If you took part in a specific earlier study (Protocol 307501): your Crohn's disease is still active at a level measured by your doctor, and any steroid use meets certain dose and tapering requirements (confirm with trial site)
• If you are a woman who could become pregnant, you have had a negative pregnancy blood test within 2 weeks before your first dose (this may sometimes be skipped if you have not stopped using contraception since your last study)
• You agree to use a reliable form of contraception throughout the study if you are sexually active and could father or become pregnant with a child
• You are able to give yourself injections of sargramostim, or someone you trust is able to do it for you
• You are able to follow all the requirements of the study
• If you took antibiotics since your last sargramostim study, a stool test has come back negative

Who may not be able to join:

• You are currently pregnant or breastfeeding
• You urgently need bowel surgery for serious problems such as active bleeding, a blockage, or an abscess that needs to be drained
• You have had bowel surgery within the last 6 months
• You have had symptoms of a bowel blockage or a confirmed significant narrowing of the bowel in the last 6 months that has not been surgically treated
• Your kidney function blood test result is above a certain level, suggesting reduced kidney function (confirm with trial site)
• Certain liver, blood count, or other blood test results are outside acceptable ranges (confirm specific values with trial site)
• You have used certain anti-inflammatory medications known as anti-TNF treatments (such as infliximab) within the 8 weeks before your first dose in this study
• You have used certain immune-suppressing medications (including azathioprine, methotrexate, cyclosporine, or similar drugs) within the 4 weeks before your first dose
• You have taken part in any other clinical trial using an experimental drug since your last sargramostim study
• You have a known allergy to yeast products or to sargramostim
• You have a mental health condition or substance use problem that could make it difficult to follow the study requirements or give informed consent
• You have another serious medical condition unrelated to Crohn's disease
• You have previously been treated with the drug natalizumab (also known as Tysabri)

Important: Always verify eligibility with the trial site directly before applying.