Trials / Completed
CompletedNCT00206674
Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease
Phase 3 Randomized, Double-Blind, Placebo Controlled Induction Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 286 (actual)
- Sponsor
- Genzyme, a Sanofi Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate if Leukine can induce clinical response or remission in patients with 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) | 6µg/kg SARGRAMOSTIM subcutaneous daily for 8 weeks |
| DRUG | Placebo | Sterile liquid solution, inactive excipient only subcutaneous daily for 8 weeks |
Timeline
- Start date
- 2004-09-01
- Primary completion
- 2006-06-01
- Completion
- 2006-06-01
- First posted
- 2005-09-21
- Last updated
- 2013-12-04
Locations
70 sites across 9 countries: Argentina, Australia, Brazil, Canada, New Zealand, Russia, Switzerland, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT00206674. Inclusion in this directory is not an endorsement.