Retrospective Cohort Study of Rebif® Use in Pediatric Multiple Sclerosis (MS) Subjects (REPLAY)
Information source: EMD Serono
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis
Intervention: Rebif® (Drug)
Phase: N/A
Status: Completed
Sponsored by: EMD Serono Official(s) and/or principal investigator(s): Medical Responsible, Study Director, Affiliation: EMD Serono Inc., a subsidiary of Merck KGaA, Darmstadt, Germany
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.
Clinical Details
Official title: Retrospective Cohort Study of Rebif® Use in Pediatric MS Patients
Study design: Observational Model: Cohort, Time Perspective: Retrospective
Primary outcome: Number of Participants With Pre-specified Medical EventsNumber of Participants With Serious Medical Events, and Non-serious Medical Events (Reported by the Investigator as Related to Rebif®) Number of Participants With Abnormal Laboratory Parameters
Secondary outcome: Annualized Medically Confirmed Clinical Relapses Rate Prior to Rebif® Initiation and During Rebif® TreatmentTime to First Medically Confirmed Clinical Relapse Post-Rebif® Initiation
Eligibility
Minimum age: N/A.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Research Site, Buenos Aires, Argentina
Research Site, Toronto, Canada
Research Site, Le Kremlin Bicêtre Cedex, France
Research Site, Bari, Italy
Research Site, Catania, Italy
Research Site, Gallarate, Italy
Research Site, Milan, Italy
Research Site, Rome, Italy
Research Site, Torino, Italy
Research Site, Moscow, Russian Federation
Research Site, Tunis, Tunisia
Research Site, Maracaibo, Venezuela
Research Site, Birmingham, Alabama, United States
Research Site, San Francisco, California, United States
Research Site, Boston, Massachusetts, United States
Research Site, Buffalo, New York, United States
Research Site, Rochester, New York, United States
Research Site, Stoney Brook, New York, United States
Additional Information
Starting date: July 2010
Last updated: April 27, 2015
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