A Phase 2 interventional study of Sargramostim (Leukine) and Placebo in Crohn's Disease, sponsored by Genzyme, a Sanofi Company. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-04.
Sponsored by Genzyme, a Sanofi Company · Phase 2, Interventional, and Treatment
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 11 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Genzyme, a Sanofi Company is the lead sponsor of 303 studies on the registry; 5 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Sargramostim (Leukine)
Drug: Placebo
Self-subcutaneous injection
Also known as: BAY86-5326
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
No study locations are listed for this record.
This study is terminated, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Genzyme, a Sanofi Company