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

Merck KGaA (EMD Serono)

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Drug: Rebif®

Study type: Observational

Funder types: Industry

Identifiers

NCT01207648

EMR 200136-024

Details and patient eligibility

About

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.

Enrollment: 307 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Received one or more injections of Rebif® for treatment of a demyelinating event
• Be younger than 18 years of age at time of Rebif® treatment initiation
• Rebif® therapy must have been initiated before June 30, 2009

Exclusion criteria

No exclusion criteria are applied

Trial design

307 participants in 1 patient group

Retrospective Cohort

Description:

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 were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available on site till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.

Treatment:

Drug: Rebif®