Ignite Creation Date:
2024-05-05 @ 9:08 PM
Last Modification Date:
2024-10-26 @ 9:59 AM
Study NCT ID:
NCT00813709
Status:
COMPLETED
Last Update Posted:
2017-03-08
First Post:
2008-12-22
Brief Title:
Long-term Follow-Up of Patients Who Participated in Study 27025 REFLEX
Sponsor:
Merck KGaA Darmstadt Germany
Organization:
Merck KGaA Darmstadt Germany
Study Overview
Official Title:
Double-blind Extension of the Study 27025 REFLEX to Obtain Long-term Follow-up Data in Patients With Clinically Definite MS and Patients With a First Demyelinating Event at High Risk of Converting to MS Treated With Rebif New Formulation REFLEXION
Status:
COMPLETED
Status Verified Date:
2017-01
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:
REFLEXION
Brief Summary:
REFLEXION is a double blind extension of the study 27025 NCT00404352 REFLEX The purpose of the study is to obtain long-term follow-up data in subjects with clinically definite multiple sclerosis MS and subjects with a first demyelinating event at high risk of converting to MS treated with fetal bovine serum FBS-freehuman serum albumin HSA-free formulation of interferon IFN-beta-1a RNF
Detailed Description:
The objective of the study is to investigate whether RNF treatment initiated after the first clinical event versus delayed treatment results in the prolongation of time to Clinically Definite Multiple Sclerosis CDMS conversion up to Month 36 and up to Month 60 since randomization in Study 27025 REFLEX Furthermore the study is intended to explore whether RNF treatment initiated after the first clinical event versus delayed treatment delays disability including development of secondary progressive MS and reduces disease activity including the annual relapse rate ARR in the long term up to Month 36 and up to Month 60 since randomization in Study 27025 REFLEX The study will also assess the long-term safety profile of RNF up to Month 36 and up to Month 60 since randomization in Study 27025 REFLEX
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