N/A
Completed N=307
Retrospective Cohort Study of Rebif® Use in Pediatric Multiple Sclerosis (MS) Subjects (REPLAY)
Source: ClinicalTrials.gov NCT01207648 ↗Enrolled (actual)
307
Serious AEs
3.9%
Results posted
May 2013
Primary outcomePrimary: Number of Participants With Pre-specified Medical Events — 85; 75; 44; 14 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Pre-specified Medical Events |
85; 75; 44; 14; 5; 5 | — |
| PRIMARY Number of Participants With Serious Medical Events, and Non-serious Medical Events (Reported by the Investigator as Related to Rebif®) |
12; 184 | — |
| PRIMARY Number of Participants With Abnormal Laboratory Parameters |
74; 59; 4; 13; 28; 38 | — |
| SECONDARY Annualized Medically Confirmed Clinical Relapses Rate Prior to Rebif® Initiation and During Rebif® Treatment |
1.79; 0.47 | — |
| SECONDARY Time to First Medically Confirmed Clinical Relapse Post-Rebif® Initiation |
19.5 | — |
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
Data sourced from ClinicalTrials.gov (NCT01207648). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.