Trials / Completed
CompletedNCT00206596
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
Randomized, Stratified, Double-Blind, Placebo-Controlled Phase 2 Study of Steroid-Sparing Properties of Sargramostim (Leukine) Therapy in Patients With Cortico-Dependent Crohn's Disease
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 127 (actual)
- Sponsor
- Genzyme, a Sanofi Company · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the effectiveness of Leukine to decrease the need for steroid treatment for Crohn's disease.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sargramostim (Leukine) | Once daily via subcutaneous injection for up 22 weeks |
| DRUG | Placebo | Once daily via subcutaneous injection for up 22 weeks |
Timeline
- Start date
- 2003-07-01
- Primary completion
- 2005-10-01
- Completion
- 2005-10-01
- First posted
- 2005-09-21
- Last updated
- 2013-12-04
Source: ClinicalTrials.gov record NCT00206596. Inclusion in this directory is not an endorsement.