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NCT01207648 · ClinicalTrials.gov registry record
Retrospective Cohort Study of Rebif® Use in Pediatric Multiple Sclerosis (MS) Subjects (REPLAY)
A clinical trial, sponsored by EMD Serono.
- Completed
- Registry status
- 307
- Enrollment target
NCT01207648: Completed study, sponsored by EMD Serono.
NCT01207648 is a clinical trial that has completed, run by EMD Serono. The registered enrollment target is 307 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01207648 has completed, sponsored by EMD Serono.
- COMPLETED
- Registry status
- 307 participants
- Enrollment target
Study 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.
Primary Outcome
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., Maligna
Interventions
- DRUG Rebif®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 307 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-07 |
What the finished NCT01207648 record still lists
NCT01207648 is an observational study that tracks outcomes without assigning an intervention. The registered 307 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Rebif® is the first listed.
NCT01207648 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01207648 about?
NCT01207648 is a clinical study titled "Retrospective Cohort Study of Rebif® Use in Pediatric Multiple Sclerosis (MS) Subjects (REPLAY)". 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...
What is the current status of trial NCT01207648?
This trial is currently completed. The enrollment target is 307 participants. The study started on 2010-07. Estimated completion is 2011-07.
What interventions are being tested in trial NCT01207648?
The interventions under investigation include: Rebif® (DRUG).
Who is sponsoring clinical trial NCT01207648?
This trial is sponsored by EMD Serono, which has 71 total clinical trials registered on ClinicalTrials.gov.
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