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

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

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

Stopped (Enrollment): “slow recruitment”

registry NUMBER FTY720 0.5 mg: 0.153 (0.111 to 0.212) relapses/year reads as mixed primary results NCT01633112 ↗

registry NUMBER GA 20 mg: 0.258 (0.196 to 0.341) relapses/year reads as mixed primary results NCT01633112 ↗

registry analysis (superiority test); FTY720 0.5 mg vs GA 20 mg; p = 0.0138; negative binomial regression model reads as mixed primary results NCT01633112 ↗

registry analysis (superiority test); FTY720 0.25 mg vs GA 20 mg; p = 0.4153; negative binomial regression model reads as mixed primary results NCT01633112 ↗

release “the ASSESS study now provides evidence that fingolimod 0.5mg is superior in reducing relapses” reads as met primary endpoint novartis.com ↗

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

Indications