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

NCT ID: NCT01556685

Last Updated: 2013-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Brief Summary

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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

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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

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Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Study Groups

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Group 1 Avonex

Approximately 90 subjects treated with IFN beta 1a IM 30μg

Group Type ACTIVE_COMPARATOR

clinical and neurological evaluation

Intervention Type OTHER

The day of the usual IFN beta 1a IM injection

Blood Sample

Intervention Type OTHER

For evaluation of interferon-related Nab

Blood Sample

Intervention Type GENETIC

genetic evaluation - predisposition to Nab generation

Group 2 Jumtab

Approximately 90 subjects treated with IFN beta 1a IM biosimilar

Group Type ACTIVE_COMPARATOR

clinical and neurological evaluation

Intervention Type OTHER

The day of the usual IFN beta 1a IM injection

Blood Sample

Intervention Type OTHER

For evaluation of interferon-related Nab

Blood Sample

Intervention Type GENETIC

genetic evaluation - predisposition to Nab generation

Interventions

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clinical and neurological evaluation

The day of the usual IFN beta 1a IM injection

Intervention Type OTHER

Blood Sample

For evaluation of interferon-related Nab

Intervention Type OTHER

Blood Sample

genetic evaluation - predisposition to Nab generation

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* To be eligible for entry into this study, candidates must meet all of the following eligibility criteria at the time of selection:

* No limitation of age, EDSS or other disease parameters will be applied.
* Subject with MS
* Subjects treated with IFN beta 1a IM (Avonex) or the biosimilar formulation of IFN beta 1a IM (Jumtab) in line with the local prescription information
* The IFN beta 1a IM (Avonex or Jumtab) treatment should be the first disease modifying treatment
* The subject should be treated with the same drug for at least 18 months and up to a maximum of 3 years

Exclusion Criteria

* No informed consent
* Patients with combination therapy (IFN + immunosuppressive therapy)
* Patients pretreated with immunosuppressive therapy
* Treatment with any investigational product, including investigational symptomatic therapies for MS (e.g., 4Aminopyridine) and investigational therapies for NonMS indications, during the review period.

NOTE: subjects may receive investigational symptomatic therapies for MS at any time prior to evaluation period.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Bogotá, , Colombia

Site Status

Research Site

León, Guanajuato, Mexico

Site Status

Countries

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Colombia Mexico

Other Identifiers

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AVX-MEX-09-17

Identifier Type: -

Identifier Source: org_study_id