Clinical trial NCT01207648: Retrospective Cohort Study of Rebif® Use in Pediatric Multiple Sclerosis (MS) Subjects (REPLAY)
Official title: Retrospective Cohort Study of Rebif® Use in Pediatric MS Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Interferon beta 1a
Autoimmune Diseases
Demyelinating Diseases
Immune System Diseases
Immunologic Factors
Nervous System Diseases
Physiological Effects of Drugs
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Retrospective Cohort Study
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
First posted: 2010-09-23
Enrollment: 307
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Every eligible subject at participating centers: subjects who have received one or more injections of Rebif® for treatment of a demyelinating event before the age of 18 and before the 30th June 2009.

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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With Pre-specified Medical Events
timeFrame: 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.
measure: Number of Participants With Serious Medical Events, and Non-serious Medical Events (Reported by the Investigator as Related to Rebif®)
timeFrame: 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.
measure: Number of Participants With Abnormal Laboratory Parameters
timeFrame: 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.
Secondary outcomes:
measure: Annualized Medically Confirmed Clinical Relapses Rate Prior to Rebif® Initiation and During Rebif® Treatment
timeFrame: 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.
measure: Time to First Medically Confirmed Clinical Relapse Post-Rebif® Initiation
timeFrame: 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.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: San Francisco
country: United States
facility: Research Site
state: California
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Buffalo
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Stoney Brook
country: United States
facility: Research Site
state: New York
city: Buenos Aires
country: Argentina
facility: Research Site
city: Toronto
country: Canada
facility: Research Site
city: Le Kremlin Bicêtre Cedex
country: France
facility: Research Site
city: Bari
country: Italy
facility: Research Site
city: Catania
country: Italy
facility: Research Site
city: Gallarate
country: Italy
facility: Research Site
city: Milan
country: Italy
facility: Research Site
city: Rome
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Tunis
country: Tunisia
facility: Research Site
city: Maracaibo
country: Venezuela
facility: Research Site
Study officials:
affiliation: EMD Serono Inc., a subsidiary of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: