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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
11
Self-subcutaneous injection
Self-subcutaneous injection
CDAI [Crohn's Disease Active Index] improvements
Time frame: Baseline, 1w, 2w, 4w, 6w, 8w, 10w, 12w
PRO [Patient-reported outcome] variables (QOL [Quality of life]
Time frame: Baseline, 1w, 4w, 8w, 12w
PGI-C [Patient global impression of change])
Time frame: Baseline, 1w, 2w, 4w, 6w, 8w, 10w, 12w
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