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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 Events

Number 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® Treatment

Time 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

Page last updated: August 23, 2015

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