Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00292253
Status:
COMPLETED
Last Update Posted:
2013-08-06
First Post:
2006-02-13
Brief Title:
Tolerability of Rebif Injection With and Without the Use of RebijectMini in Relapsing-Remitting Multiple Sclerosis Subjects
Sponsor:
EMD Serono
Organization:
EMD Serono
Study Overview
Official Title:
A Randomized Multicenter Parallel Group Open-label Study Comparing the Tolerability of Rebif Injection With and Without the Use of RebijectMini in Relapsing Remitting MS Patients
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized multicenter parallel-group open-label study comparing the tolerability of Rebif injections 44 microgram mcg administered subcutaneously three times a week with and without RebijectMini an auto-injection device in relapsing-remitting multiple sclerosis MS subjects Subjects will be randomly assigned to either one of the two Rebif groups in a 11 ratio on Study Day 1 stratified by center Subjects will receive a minimum of 3 months of treatment with Rebif 44 mcg three times a week and will be asked to assess their injection site reactions on a weekly basis Clinic visit will occur at 1 and 3 months after the initiation of treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None