Clinical Trial: Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Multicenter Extension Study to Determine the Long-Term Safety and Efficacy of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis
Brief Summary: The primary objective of the study is to evaluate the long-term safety of BG00012 in subjects who completed Study 109MS202 (NCT02410200). Secondary objectives are as follows: To evaluate the long-term efficacy of BG00012 and to describe the long-term Multiple Sclerosis (MS) outcomes in subjects who completed Study 109MS202 (NCT02410200).
Detailed Summary:
Sponsor: Biogen
Current Primary Outcome:
- The number of participants that experience adverse events (AEs) and serious adverse events (SAEs). [ Time Frame: Week 96 ]
- The number of participants that discontinue study treatment due to an AE. [ Time Frame: Week 96 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans. [ Time Frame: Week 72 ]
- The annualized relapse rate [ Time Frame: Week 96 ]
- The proportion of subjects who experience 1 or more relapses during the study period. [ Time Frame: Week 96 ]
- The degree of disability progression from baseline as measured by the Expanded Disability Status Scale (EDSS). [ Time Frame: Up to week 24 ]The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. Disability is measured as at least a 1.0-point increase on the EDSS from baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from baseline EDSS = 0 that is sustained for 24 weeks.
Original Secondary Outcome: Same as current
Information By: Biogen
Dates:
Date Received: September 17, 2015
Date Started: February 2016
Date Completion: August 2018
Last Updated: January 6, 2017
Last Verified: January 2017