Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00110396
Status:
COMPLETED
Last Update Posted:
2015-07-15
First Post:
2005-05-06
Brief Title:
Rebif New Formulation RNF in Relapsing Forms of Multiple Sclerosis
Sponsor:
EMD Serono
Organization:
EMD Serono
Study Overview
Official Title:
A Multicentre Single Arm Open-Label Phase IIIB Study to Evaluate the Safety and Antigenicity of Rebif Interferon-beta-1a in Subjects With Relapsing Forms of Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2015-06
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:
RNF
Brief Summary:
The primary objective of the study is to compare the immunogenicity of the new fetal bovine serum FBS-freehuman serum albumin HSA-free Rebif formulation RNF to historical data
Detailed Description:
As has been seen with other recombinant protein molecules the use of injectable recombinant proteins may result in the development of neutralising antibodies NAbs Antibodies are considered neutralising by their ability to inhibit the biological effect of interferon in a bioassay system EMD Serono has actively pursued improvements in the formulation of interferon IFN beta-1a to reduce aggregate levels and to develop a formulation that is HSA-free Reducing aggregates should reduce antigenicity of the product while removal of HSA may have an unpredictable effect on antigenicity EMD Serono will conduct a study to assess the immunogenicity and safety of the new HSA-free formulation manufactured using IFN-ß-1a drug substance produced by a new clone from the FBS-free process
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