Study of Sargramostim in Moderately to Severely Active Crohn's Disease
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to assess the tolerability, pharmacokinetics and safety of 2 and 6 micro g/kg/day sargramostim administered subcutaneously once daily for 4 weeks, and to assess the efficacy and safety of 6 micro g/kg/day sargramostim administered subcutaneously once daily for 8 weeks in comparison with placebo, in patients with moderately to severely active Crohn's disease.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Confirmed diagnosis of Crohn's disease (endoscopic or radiological evaluation) at least 4 months prior to receiving the first dose of study drug
- Moderately to severely active Crohn's disease at time of screening (i.e., Crohn's disease activity index [CDAI] >220 and <475 points)
Exclusion criteria
- Colostomy or ileostomy
- Immediate need for gastrointestinal (GI) surgery for active GI bleeding, peritonitis, intestinal obstruction, or intra-abdominal or perianal abscess requiring surgical drainage
- GI surgery within 6 months prior to receiving the 1st dose of study drug
- Symptoms of bowel obstruction or confirmed evidence of a clinically-significant stricture within the last 6 months that has not been surgically corrected
Trial design
Primary purpose
Allocation
Interventional model
Masking
11 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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