MATRIX: Measuring Neutralizing Antibodies in the Patients Treated With
Measuring Neutralizing Antibodies in the Patients Treated With Interferon Beta 1a IM, in Mexico and Colombia
What it found
We found no results in the registry or in papers.
This trial finished 15 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- clinical and neurological evaluation
- Blood Sample
What it measured
Main measures
Neutralizing antibodies to Interferon beta 1a IM (Avonex) or IFN beta 1a IM biosimilar
Day 1
Immune responsePercentage of patients with interferon induced Nabs measured in luciferase test
Day 1
Immune responseneutralizing antibodies to IFN beta 1a IM (Avonex) or IFN beta 1a IM biosimilar formulation (Jumtab)
1 day
Immune responsePercent of patients with interferon induced neutralizing antibodies measured in a luciferase test
1 day
Immune response
Other measures (9)
Rate and duration of corticosteroid use for relapse
Day 1
RelapsesNeed and duration of hospitalization for relapse
Day 1
RelapsesGenetic profile of patients with relation to their predisposition to Nab development
Day 1
The interferon activity will be tested by neopterin protein activation (level before IFNbeta1a IM injection and 48 hours after the injection)
twice measured: - Day 1 before IFN injection - 48-72hours after the IFN injection
Immune responseGenetic profile of population with relation to predisposition to Nab generation
Day 1
Rate/ duration of corticosteroid use for relapse
measured up to 3 years prior to enrollment @ Day 1
RelapsesNeed/ duration of hospitalization for relapse
measured up to 3 years prior to enrollment @ Day 1
RelapsesGenetic profile of patients with relation to the predisposition to Nab development
1 day
Interferon activity will be tested by neopterin protein activation before and after injection
48-72 hours
Immune response
Who could take part
MS (type not specified)
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Mar 2011
Main results due
Oct 2011