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Retrospective Cohort Study of Rebif Use in Pediatric MS Patients (REPLAY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT01207648
First received: September 21, 2010
Last updated: March 8, 2012
Last verified: March 2012
History of Changes
  Purpose

The aim of this study is to review and describe safety, tolerability and efficacy of Rebif (sc IFN-beta-1a) in children and adolescents, using information already recorded in medical records. The study period is May 1998 to December 2009.


Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Cohort Study of Rebif Use in Pediatric MS Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • Safety and tolerability Outcomes [ Time Frame: the end of the study period is 31-Dec-2009 ] [ Designated as safety issue: No ]
    Pre-specified medical events post Rebif initiation regardless of seriousness and severity, all other serious medical events post Rebif initiation, all non-serious adverse drug reactions, laboratory parameters (at the time of Rebif initiation and post Rebif initiation).


Enrollment: 309
Study Start Date: July 2010
Study Completion Date: August 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cohort 1
Patients who received one or more injections of Rebif for treatment of demyelinating events

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Every eligible patient at participating centers: patients 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.

Criteria

Inclusion Criteria:

  • Received one or more injections of Rebif for treatment of a demyelinating event
  • Initiated Rebif treatment before the age of 18 and before the 30th June 2009.

Exclusion Criteria:

No additional Exclusion criteria

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01207648

Locations
United States, Alabama
Research Site
Birmingham, Alabama, United States
United States, California
Research Site
San Francisco, California, United States
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
United States, New York
Research Site
Buffalo, New York, United States
Research Site
Rochester, New York, United States
Research Site
Stoney Brook, New York, United States
Argentina
Research Site
Buenos Aires, Argentina
Canada
Research Site
Toronto, Canada
France
Research Site
Le Kremlin Bicêtre Cedex, France
Italy
Research Site
Bari, Italy
Research Site
Catania, Italy
Research Site
Gallarate, Italy
Research Site
Milan, Italy
Research Site
Rome, Italy
Research Site
Torino, Italy
Russian Federation
Research Site
Moscow, Russian Federation
Tunisia
Research Site
Tunis, Tunisia
Venezuela
Research Site
Maracaibo, Venezuela
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Sanda Rocak, PhD Merck Serono S.A., Geneva
  More Information

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
Last Updated: March 8, 2012
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

Keywords provided by EMD Serono:
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

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
 Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013