Study in Patients With Crohn's Disease Who Are Steroid Dependent, Despite Previous Unsuccessful Attempts to Reduce Steroids Due to Worsening of Crohn's Disease

• Steroid-free remission or response to treatment as defined by the protocol [ Time Frame: At the end of the study treatment ]
• Quality of Life using Inflammatory Bowel Disease Questionaire, SF 36 and EuroQol-derived visual scale (VAS) [ Time Frame: At the end of the study treatment ]

The purpose of this study is to evaluate the effectiveness of Leukine to decrease the need for steroid treatment for Crohn's disease.

On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.

• Drug: Sargramostim (Leukine)
  Once daily via subcutaneous injection for up 22 weeks
  Other Name: BAY86-5326
• Drug: Placebo
  Once daily via subcutaneous injection for up 22 weeks

• Experimental: Arm 1
  Intervention: Drug: Sargramostim (Leukine)
• Placebo Comparator: Arm 2
  Intervention: Drug: Placebo

Inclusion Criteria:

• You must have active Crohn's disease at screening and been diagnosed with Crohn's disease within 6 months at screening.
• You must have steroid dependent disease (receiving between 10-40 mgs/day prednisone therapy for greater than 3 months prior to screening and had at least one unsuccessful attempt to reduce cortico-steroids due to worsening of disease).
• You must be able to give yourself an injection of study drug or have another person help you give the injection.
• You must not be pregnant and agree to use birth control if you are a sexually active male or female of childbearing potential.

Exclusion Criteria:

• You may not be taking medications not allowed on this study.
• You may not have had GI surgery or bowel obstruction in the last 6 months.
• You may not have ever taken this drug or drugs of similar type in the past.