- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01556685
MATRIX: Measuring Neutralizing Antibodies in the Patients Treated With Interferon Beta 1a IM, in Mexico and Colombia (MATRIX)
Measuring Neutralizing Antibodies in the Patients Treated With Interferon Beta 1a IM, in Mexico and Colombia
Study Overview
Status
Conditions
Intervention / 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
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1 Avonex
Approximately 90 subjects treated with IFN beta 1a IM 30μg
|
The day of the usual IFN beta 1a IM injection
For evaluation of interferon-related Nab
genetic evaluation - predisposition to Nab generation
|
Active Comparator: Group 2 Jumtab
Approximately 90 subjects treated with IFN beta 1a IM biosimilar
|
The day of the usual IFN beta 1a IM injection
For evaluation of interferon-related Nab
genetic evaluation - predisposition to Nab generation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Neutralizing antibodies to Interferon beta 1a IM (Avonex) or IFN beta 1a IM biosimilar
Time Frame: Day 1
|
Day 1
|
Percentage of patients with interferon induced Nabs measured in luciferase test
Time Frame: Day 1
|
Day 1
|
neutralizing antibodies to IFN beta 1a IM (Avonex) or IFN beta 1a IM biosimilar formulation (Jumtab)
Time Frame: 1 day
|
1 day
|
Percent of patients with interferon induced neutralizing antibodies measured in a luciferase test
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate and duration of corticosteroid use for relapse
Time Frame: Day 1
|
Day 1
|
Need and duration of hospitalization for relapse
Time Frame: Day 1
|
Day 1
|
Genetic profile of patients with relation to their predisposition to Nab development
Time Frame: Day 1
|
Day 1
|
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
|
twice measured: - Day 1 before IFN injection - 48-72hours after the IFN injection
|
Genetic profile of population with relation to predisposition to Nab generation
Time Frame: Day 1
|
Day 1
|
Rate/ duration of corticosteroid use for relapse
Time Frame: measured up to 3 years prior to enrollment @ Day 1
|
measured up to 3 years prior to enrollment @ Day 1
|
Need/ duration of hospitalization for relapse
Time Frame: measured up to 3 years prior to enrollment @ Day 1
|
measured up to 3 years prior to enrollment @ Day 1
|
Genetic profile of patients with relation to the predisposition to Nab development
Time Frame: 1 day
|
1 day
|
Interferon activity will be tested by neopterin protein activation before and after injection
Time Frame: 48-72 hours
|
48-72 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AVX-MEX-09-17
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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