drugset / Trial / NCT00329537
Study of Sargramostim in Moderately to Severely Active Crohn's Disease
RandomizedParallel-groupDouble-blindTreatment
Summary
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.
Timeline
- Start
- 2006-06
- Primary completion
- 2007-05
- Completion
- 2007-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | sargramostim | Protein / enzyme biologic | 2 ug/kg | Subcutaneous |
| Subject | sargramostim | Protein / enzyme biologic | 6 ug/kg | Subcutaneous |