MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone

Phase 3 Terminated 1064 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study was to demonstrate that at least one dose (0.5 mg followed by 0.25 mg) of fingolimod is superior to glatiramer acetate 20 mg SC in reducing the ARR up to 12 months in patients with relapsing-remitting MS

Timeline

Start: 2012-08-09
Primary completion: 2018-04-30
Completion: 2018-04-30

Publications

Cree BAC, Goldman MD, Corboy JR, Singer BA, Fox EJ, Arnold DL, Ford C, Weinstock-Guttman B, Bar-Or A, Mientus S, Sienkiewicz D, Zhang Y, Karan R, Tenenbaum N; ASSESS Trial Investigators. Efficacy and Safety of 2 Fingolimod Doses vs Glatiramer Acetate for the Treatment of Patients With Relapsing-Remitting Multiple Sclerosis: A Randomized Clinical Trial. JAMA Neurol. 2020 Aug 24;78(1):1-13. doi: 10.1001/jamaneurol.2020.2950. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fingolimod	Small molecule	0.25 mg	Oral
Subject	Fingolimod	Small molecule	0.5 mg	Oral
Comparator	Glatiramer Acetate	Small molecule	20 mg	Subcutaneous

MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone

Summary

Timeline

Publications

Drugs

Indications