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

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Retrospective
Condition:	Multiple Sclerosis

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Retrospective Cohort	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 till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.

Description

Retrospective Cohort

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 till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.

Participant Flow: Overall Study

	Retrospective Cohort
STARTED	307
COMPLETED	307
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Retrospective Cohort	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 till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.

Description

Retrospective Cohort

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 till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.

Baseline Measures

	Retrospective Cohort
Number of Participants [units: participants]	307
Age [units: years] Mean ± Standard Deviation	14.0 ± 3.0
Gender [units: participants]
Female	190
Male	117

Outcome Measures

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1. Primary:

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. ]

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2. Primary:

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. ]

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3. Primary:

Number of Participants With Abnormal Laboratory Parameters [ 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. ]

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4. Secondary:

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. ]

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5. Secondary:

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. ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No text entered.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
phone: +49-6151-72-5200
e-mail: service@merck.de

No publications provided

Responsible Party:	EMD Serono
ClinicalTrials.gov Identifier:	NCT01207648 History of Changes
Other Study ID Numbers:	EMR 200136-024
Study First Received:	September 21, 2010
Results First Received:	April 8, 2013
Last Updated:	April 8, 2013
Health Authority:	Argentina: Human Research Bioethics Committee Canada: Ethics Review Committee France: French Data Protection Authority and National Consultative Ethics Committee for Health and Life Sciences Italy: Ethics Committee Russia: Ethics Committee Tunisia: Ethics Committee United States: Institutional Review Board Venezeula: Ethics Committee