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

NCT01207648 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 307

Last updated 2015-05-15

Study results available
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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

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Medical Responsible · EMD Serono Inc., a subsidiary of Merck KGaA, Darmstadt, Germany

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States
  • Argentina
  • Canada
  • France
  • Italy
  • Russia
  • Tunisia
  • Venezuela

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01207648 on ClinicalTrials.gov