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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
clinical and neurological evaluation
Blood Sample
Blood Sample
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of selection:

    • 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.

Sites / Locations

  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1 Avonex

Group 2 Jumtab

Arm Description

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

Approximately 90 subjects treated with IFN beta 1a IM biosimilar

Outcomes

Primary Outcome Measures

Neutralizing antibodies to Interferon beta 1a IM (Avonex) or IFN beta 1a IM biosimilar
Percentage of patients with interferon induced Nabs measured in luciferase test
neutralizing antibodies to IFN beta 1a IM (Avonex) or IFN beta 1a IM biosimilar formulation (Jumtab)
Percent of patients with interferon induced neutralizing antibodies measured in a luciferase test

Secondary Outcome Measures

Rate and duration of corticosteroid use for relapse
Need and duration of hospitalization for relapse
Genetic profile of patients with relation to their predisposition to Nab development
The interferon activity will be tested by neopterin protein activation (level before IFNbeta1a IM injection and 48 hours after the injection)
Genetic profile of population with relation to predisposition to Nab generation
Rate/ duration of corticosteroid use for relapse
Need/ duration of hospitalization for relapse
Genetic profile of patients with relation to the predisposition to Nab development
Interferon activity will be tested by neopterin protein activation before and after injection

Full Information

First Posted
October 20, 2011
Last Updated
September 12, 2013
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT01556685
Brief Title
MATRIX: Measuring Neutralizing Antibodies in the Patients Treated With Interferon Beta 1a IM, in Mexico and Colombia
Acronym
MATRIX
Official Title
Measuring Neutralizing Antibodies in the Patients Treated With Interferon Beta 1a IM, in Mexico and Colombia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Allocation
Non-Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 Avonex
Arm Type
Active Comparator
Arm Description
Approximately 90 subjects treated with IFN beta 1a IM 30μg
Arm Title
Group 2 Jumtab
Arm Type
Active Comparator
Arm Description
Approximately 90 subjects treated with IFN beta 1a IM biosimilar
Intervention Type
Other
Intervention Name(s)
clinical and neurological evaluation
Intervention Description
The day of the usual IFN beta 1a IM injection
Intervention Type
Other
Intervention Name(s)
Blood Sample
Intervention Description
For evaluation of interferon-related Nab
Intervention Type
Genetic
Intervention Name(s)
Blood Sample
Intervention Description
genetic evaluation - predisposition to Nab generation
Primary Outcome Measure Information:
Title
Neutralizing antibodies to Interferon beta 1a IM (Avonex) or IFN beta 1a IM biosimilar
Time Frame
Day 1
Title
Percentage of patients with interferon induced Nabs measured in luciferase test
Time Frame
Day 1
Title
neutralizing antibodies to IFN beta 1a IM (Avonex) or IFN beta 1a IM biosimilar formulation (Jumtab)
Time Frame
1 day
Title
Percent of patients with interferon induced neutralizing antibodies measured in a luciferase test
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Rate and duration of corticosteroid use for relapse
Time Frame
Day 1
Title
Need and duration of hospitalization for relapse
Time Frame
Day 1
Title
Genetic profile of patients with relation to their predisposition to Nab development
Time Frame
Day 1
Title
The interferon activity will be tested by neopterin protein activation (level before IFNbeta1a IM injection and 48 hours after the injection)
Time Frame
twice measured: - Day 1 before IFN injection - 48-72hours after the IFN injection
Title
Genetic profile of population with relation to predisposition to Nab generation
Time Frame
Day 1
Title
Rate/ duration of corticosteroid use for relapse
Time Frame
measured up to 3 years prior to enrollment @ Day 1
Title
Need/ duration of hospitalization for relapse
Time Frame
measured up to 3 years prior to enrollment @ Day 1
Title
Genetic profile of patients with relation to the predisposition to Nab development
Time Frame
1 day
Title
Interferon activity will be tested by neopterin protein activation before and after injection
Time Frame
48-72 hours

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of selection: 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.
Facility Information:
Facility Name
Research Site
City
Bogota
Country
Colombia
Facility Name
Research Site
City
Leon
State/Province
Guanajuato
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

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

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