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

Multiple Sclerosis Clinical Trial

— REPLAY  

Official title:

Retrospective Cohort Study of Rebif® Use in Pediatric MS Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01207648
• Other study ID #: EMR 200136-024
• Status: Completed
• Phase: N/A
• First received: September 21, 2010
• Last updated: April 27, 2015
• Start date: July 2010
• Est. completion date: July 2011

Study information

• Verified date: April 2015
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Human Research Bioethics CommitteeCanada: Ethics Review CommitteeFrance: French Data Protection Authority and National Consultative Ethics Committee for Health and Life SciencesItaly: Ethics CommitteeRussia: Ethics CommitteeTunisia: Ethics CommitteeUnited States: Institutional Review BoardVenezeula: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Rebif®
This is an retrospective cohort study in 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 (Dose regimen as per investigator's decision)

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Canada	Research Site	Toronto
France	Research Site	Le Kremlin Bicêtre Cedex
Italy	Research Site	Bari
Italy	Research Site	Catania
Italy	Research Site	Gallarate
Italy	Research Site	Milan
Italy	Research Site	Rome
Italy	Research Site	Torino
Russian Federation	Research Site	Moscow
Tunisia	Research Site	Tunis
United States	Research Site	Birmingham	Alabama
United States	Research Site	Boston	Massachusetts
United States	Research Site	Buffalo	New York
United States	Research Site	Rochester	New York
United States	Research Site	San Francisco	California
United States	Research Site	Stoney Brook	New York
Venezuela	Research Site	Maracaibo

Sponsors (1)

Lead Sponsor	Collaborator
EMD Serono

Countries where clinical trial is conducted

United States,  Venezuela,  Argentina,  Canada,  France,  Italy,  Russian Federation,  Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Pre-specified Medical Events	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.	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.	Yes
Primary	Number of Participants With Serious Medical Events, and Non-serious Medical Events (Reported by the Investigator as Related to Rebif®)	Medical events in the retrospective study are equivalent to adverse events in a prospective clinical study. A medical event was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered. Serious medical event: A medical event that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition. Participants may be represented in more than one category as participant who had experienced serious medical event may also had experienced non-serious medical event reported by the Investigator as related to Rebif®, so in that case it will be counted in both the categories.	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.	Yes
Primary	Number of Participants With Abnormal Laboratory Parameters	Laboratory parameters assessed for abnormality were: total white blood cell count (Neutrophils, Lymphocytes, Leukocytes, Monocytes, Eosinophils and Basophils), differential hematogram (Hematocrit, Erythrocytes, Hemoglobin, and Platelet), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and thyroid tests (including Triiodothyronine, Thyroxine, Thyroperoxidase Antibody and Thyroid-Stimulating Hormone). Due to the retrospective nature of the study, laboratory data should be interpreted with caution as data were not collected according to a specific time schedule and the time on study per participant was not standardized.	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.	Yes
Secondary	Annualized Medically Confirmed Clinical Relapses Rate Prior to Rebif® Initiation and During Rebif® Treatment	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.	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.	No
Secondary	Time to First Medically Confirmed Clinical Relapse Post-Rebif® Initiation	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.	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.	No