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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Retrospective Cohort Study of Rebif® Use in Pediatric MS Patients

Brief 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.

Detailed Summary:
Sponsor: EMD Serono

Current Primary Outcome:

  • Number of Participants With Pre-specified Medical Events [ Time Frame: Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first. ]
    These pre-specified medical events categories were evaluated: injections site reactions, flu-like symptoms, hepatic disorders, blood cell disorders, allergic reactions, epilepsy and convulsive disorders, thyroid dysfunction, autoimmune diseases, bone/epiphyseal and cartilage disorders, serious infections, malignancies. Each category defined by group of events which best fit the medical concept either using a standard medical dictionary for regulatory activities (MedDRA) Query (SMQ) e.g., Malignancies was defined by the SMQ Malignancies (narrow scope) containing more than 1800 different preferred terms (PTs) (including procedures and lab tests) or using a customized query, e.g., Serious infections was defined by all PTs assessed as serious in System Organ Class (SOC) Infections and Infestation. Participants may be represented in more than once in a category (Participants could have reported several medicals events pertaining to a specific category) as well as in more than one category.
  • Number of Participants With Serious Medical Events, and Non-serious Medical Events (Reported by the Investigator as Related to Rebif®) [ Time Frame: Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first. ]
    Medical events in the retrospective study are equivalent to adverse events in a prospective clinical study. A medical event was defined a

    Original Primary Outcome: Safety and tolerability Outcomes [ Time Frame: the end of the study period is 31-Dec-2009 ]

    Pre-specified medical events post Rebif initiation regardless of seriousness and severity, all other serious medical events post Rebif initiation, all non-serious adverse drug reactions, laboratory parameters (at the time of Rebif initiation and post Rebif initiation).


    Current Secondary Outcome:

    • Annualized Medically Confirmed Clinical Relapses Rate Prior to Rebif® Initiation and During Rebif® Treatment [ Time Frame: Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first. ]
      Medically confirmed clinical relapses were defined as the emergence of new neurological symptoms that occurred more than 30 days after a previous attack and persisted for more than or equal to 24 hours in the absence of known inter-current illness. Annualized relapse rate was defined as number of attacks per year.
    • Time to First Medically Confirmed Clinical Relapse Post-Rebif® Initiation [ Time Frame: Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first. ]
      Medically confirmed clinical relapses were defined as the emergence of new neurological symptoms that occurred more than 30 days after a previous attack and persisted for more than or equal to 24 hours in the absence of known inter-current illness.


    Original Secondary Outcome:

    Information By: EMD Serono

    Dates:
    Date Received: September 21, 2010
    Date Started: July 2010
    Date Completion:
    Last Updated: April 27, 2015
    Last Verified: April 2015