Assessment Study of Steroid Effect in Relapsing Multiple Sclerosis Subjects Treated With Glatiramer Acetate

NCT00203047 ↗

Phase 4 Terminated 414 enrolled Teva Branded Pharmaceutical Products R&D, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a study evaluating the effect on brain volume of daily glatiramer acetate (GA) and add-on pulse steroids.

Timeline

Start: 2005-01
Primary completion: 2009-05
Completion: 2009-05

Outcome

Missed primary endpoint

Stopped (Enrollment): “Slow enrollment decreased sample size; No unexpected safety issues.”

registry analysis (superiority or other test); GA + Placebo vs GA + Prednisone; p = 0.8023; Mean Difference (Final Values) -0.03 (95% CI -0.26 to 0.20); ANCOVA NCT00203047 ↗

Publications

Results Milo R, Panitch H. Combination therapy in multiple sclerosis. J Neuroimmunol. 2011 Feb;231(1-2):23-31. doi: 10.1016/j.jneuroim.2010.10.021. Epub 2010 Dec 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Prednisone	Other / unclassified	1250 mg	—
Background	Glatiramer Acetate	Small molecule	10 mg	Subcutaneous
Background	Glatiramer Acetate	Small molecule	20 mg	Subcutaneous