Clinical Trial: Safety and Efficacy Study in the Treatment of Pediatric Crohn's Disease
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Phase 1/2 Safety, Pharmacokinetic, and Pharmacodynamic Study of Sargramostim (Leukine®) in Pediatric Patients With Active Crohn's Disease, With One-year Surveillance
Brief Summary: The purpose of this study is to observe pediatric Crohn's Disease response to sargramostim in patients with or without steroid therapy at two possible dosage levels.
Detailed Summary: 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.
Sponsor: Genzyme, a Sanofi Company
Current Primary Outcome: Characterize the safety profile of sargramostim treatment with concomitant corticosteroid induction therapy [ Time Frame: 12 weeks ]
Original Primary Outcome: Safety at one year
Current Secondary Outcome:
- Characterize the pharmacokinetic, pharmacodynamics properties of sargramostim treatment with concomitant corticosteroid induction therapy [ Time Frame: Week 0, 1, and 2 ]
- Evaluate the efficacy of sargramostim treatment with concomitant corticosteroids as measured by the Pediatric Crohn's Disease Activity Index (PCDAI), Physician's Global Assessment (PGA), and IMPACT-III Questionnaire [ Time Frame: PCDAI, PGA: Week -1 to EOS; IMPACT-II: Week 0, 8 and EOS ]
Original Secondary Outcome:
- Determine pharmacokinetic, pharmacodynamics with and without steroid therapy
- Determine efficacy in pediatric Crohn’s Disease
Information By: Sanofi
Dates:
Date Received: September 12, 2005
Date Started: December 2004
Date Completion:
Last Updated: December 2, 2013
Last Verified: December 2013
