NCT01207648

Retrospective Cohort Study of Rebif® Use in Pediatric Multiple Sclerosis (MS) Subjects (REPLAY)

Retrospective Cohort Study of Rebif® Use in Pediatric MS Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 307 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this retrospective study is to review and describe safety, tolerability and efficacy of Rebif® (subcutaneous interferon \[IFN\]-beta-1a) in children and adolescents, using information already recorded in medical records. The study duration is 13 July 2010 (first data collected) to 13 July 2011 (last data collected). In this study, Data of the subjects evaluated between 1997 and 2009 was observed.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Rebif®	This is an retrospective cohort study in Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events (Dose regimen as per investigator's decision)

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-09-23
• Last updated: 2015-05-15
• Results posted: 2013-05-30

Locations

18 sites across 8 countries: United States, Argentina, Canada, France, Italy, Russia, Tunisia, Venezuela