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

NCT00206596 ↗

Phase 2 Completed 127 enrolled Genzyme, a Sanofi Company

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate the effectiveness of Leukine to decrease the need for steroid treatment for Crohn's disease.

Timeline

Start: 2003-07
Primary completion: 2005-10
Completion: 2005-10

Outcome

Met primary endpoint

paper Significantly more sargramostim-treated patients than placebo patients achieved corticosteroid-free remission (18.6% vs 4.9%; p = 0.03). PMID 19505878 ↗

Publications

Valentine JF, Fedorak RN, Feagan B, Fredlund P, Schmitt R, Ni P, Humphries TJ. Steroid-sparing properties of sargramostim in patients with corticosteroid-dependent Crohn's disease: a randomised, double-blind, placebo-controlled, phase 2 study. Gut. 2009 Oct;58(10):1354-62. doi: 10.1136/gut.2008.165738. Epub 2009 Jun 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	sargramostim	Protein / enzyme biologic	6 ug/kg	Subcutaneous