NCT01556685

MATRIX: Measuring Neutralizing Antibodies in the Patients Treated With Interferon Beta 1a IM, in Mexico and Colombia

Measuring Neutralizing Antibodies in the Patients Treated With Interferon Beta 1a IM, in Mexico and Colombia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	clinical and neurological evaluation	The day of the usual IFN beta 1a IM injection
OTHER	Blood Sample	For evaluation of interferon-related Nab
GENETIC	Blood Sample	genetic evaluation - predisposition to Nab generation

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-10-01
• First posted: 2012-03-16
• Last updated: 2013-09-16

Locations

2 sites across 2 countries: Colombia, Mexico