Natalizumab as an Efficacy Switch in Participants With Relapsing Multiple Sclerosis After Failure on Other Therapies
Stopped early · Phase 4
Conditions studied: Relapsing Multiple Sclerosis
In brief
The primary objective of the study is to determine the efficacy of natalizumab (Tysabri, BG00002) in participants with relapsing forms of multiple sclerosis (MS) who have failed Gilenya or BRACET (Betaseron, Rebif, Avonex, Copaxone, Extavia, Tecfidera) as measured by the proportion of participants with no evidence of disease activity (NEDA) at Year 1. The secondary objectives in this study population are: change in total T1 hypointense and total T2 hyperintense lesion volume; proportion of participants with NEDA at Year 2; evaluation of the impact of natalizumab on annualized relapse rate (ARR); and change in Multiple Sclerosis Impact Scale-29 (MSIS-29) physical impact score.
Key facts
- Study ID
- NCT02241785
- Run by
- Biogen
- People needed
- 47
- Starts
- 2014-09-30
- Expected to finish
- 2016-05-02
- Last updated by the study team
- 2017-06-05
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Research Site — Fullerton, California, United States
- Research Site — Aurora, Colorado, United States
- Research Site — Des Moines, Iowa, United States
- Research Site — St Louis, Missouri, United States
- Research Site — Plainview, New York, United States
- Research Site — Raleigh, North Carolina, United States
- Research Site — Akron, Ohio, United States
- Research Site — Cleveland, Ohio, United States
- Research Site — Knoxville, Tennessee, United States
- Research Site — Round Rock, Texas, United States
- Research Site — Tacoma, Washington, United States
Full record on ClinicalTrials.gov
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