Ignite Creation Date:
2024-05-06 @ 12:20 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01556685
Status:
COMPLETED
Last Update Posted:
2013-09-16
First Post:
2011-10-20
Brief Title:
MATRIX Measuring Neutralizing Antibodies in the Patients Treated With Interferon Beta 1a IM in Mexico and Colombia
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
Measuring Neutralizing Antibodies in the Patients Treated With Interferon Beta 1a IM in Mexico and Colombia
Status:
COMPLETED
Status Verified Date:
2012-03
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:
MATRIX
Brief Summary:
This is a cross sectional Phase 4 multicenter study of AVONEX and JUMTAB to determine the frequency of IFN induced Neutralizing Antibodies Nabs A secondary component is the long term retrospective observational evaluation conducted to measure efficacy adherence to therapy tolerability and safety in subjects with relapsing MS related to antibody status and treatment
Detailed Description:
The primary objective of this study is to evaluate the frequency of neutralizing antibodies in patients treated with IFN beta 1a IM Avonex and IFN beta 1a IM biosimilar formulation Jumtab
Secondary objectives
Evaluate the effect of Nabs on the severity of the relapses on each treatment group measured by
The need and duration of steroid courses
The need and duration for hospitalization
To evaluate the safety and tolerability of the IFN beta 1a IM treatments Avonex and Jumtab
To identify the genetic profile of the patients with relation to the predisposition to Nab development HLA DR4 in particular HLADRB1 0401 and 0408 and DR16 in particular HLADRB1 1601
At selected sites To evaluate the influence of the interferon and the Nabs on the activation of neopterin
Secondary objectives
Evaluate the effect of Nabs on the severity of the relapses on each treatment group measured by
The need and duration of steroid courses
The need and duration for hospitalization
To evaluate the safety and tolerability of the IFN beta 1a IM treatments Avonex and Jumtab
To identify the genetic profile of the patients with relation to the predisposition to Nab development HLA DR4 in particular HLADRB1 0401 and 0408 and DR16 in particular HLADRB1 1601
At selected sites To evaluate the influence of the interferon and the Nabs on the activation of neopterin
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