Multiple SclerosisPhase 4MATRIXNCT01556685
MATRIX: Measuring Neutralizing Antibodies in the Patients Treated With Interferon Beta 1a IM, in Mexico and Colombia
A Phase 4 study testing clinical and neurological evaluation and Blood Sample in people with Multiple Sclerosis, run by Biogen at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- clinical and neurological evaluation and Blood Sample
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2011to Oct 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Measuring Neutralizing Antibodies in the Patients Treated With Interferon Beta 1a IM, in Mexico and Colombia
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.
Read the 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
- Being tested
- clinical and neurological evaluation, Blood Sample
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical and neurological evaluationOther
The day of the usual IFN beta 1a IM injection
Blood SampleOther
For evaluation of interferon-related Nab
Blood SampleGenetic
genetic evaluation - predisposition to Nab generation
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Avonex | Active comparator | Approximately 90 subjects treated with IFN beta 1a IM 30μg Receives: Other: clinical and neurological evaluation; Other: Blood Sample; Genetic: Blood Sample |
| Group 2 Jumtab | Active comparator | Approximately 90 subjects treated with IFN beta 1a IM biosimilar Receives: Other: clinical and neurological evaluation; Other: Blood Sample; Genetic: Blood Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutralizing antibodies to Interferon beta 1a IM (Avonex) or IFN beta 1a IM biosimilar
Measured: Day 1
Percentage of patients with interferon induced Nabs measured in luciferase test
Measured: Day 1
neutralizing antibodies to IFN beta 1a IM (Avonex) or IFN beta 1a IM biosimilar formulation (Jumtab)
Measured: 1 day
Percent of patients with interferon induced neutralizing antibodies measured in a luciferase test
Measured: 1 day
Secondary outcomes (9)
Rate and duration of corticosteroid use for relapse
Measured: Day 1
Need and duration of hospitalization for relapse
Measured: Day 1
Genetic profile of patients with relation to their predisposition to Nab development
Measured: Day 1
The interferon activity will be tested by neopterin protein activation (level before IFNbeta1a IM injection and 48 hours after the injection)
Measured: twice measured: - Day 1 before IFN injection - 48-72hours after the IFN injection
Genetic profile of population with relation to predisposition to Nab generation
Measured: Day 1
Rate/ duration of corticosteroid use for relapse
Measured: measured up to 3 years prior to enrollment @ Day 1
Need/ duration of hospitalization for relapse
Measured: measured up to 3 years prior to enrollment @ Day 1
Genetic profile of patients with relation to the predisposition to Nab development
Measured: 1 day
Interferon activity will be tested by neopterin protein activation before and after injection
Measured: 48-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startMar 2011
- Primary completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556685
- Sponsor's protocol ID
- AVX-MEX-09-17
- Acronym
- MATRIX
- Status last verified
- Mar 2012
- First submitted
- 20 Oct 2011
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Neutralizing Antibodies in the Patients Treated With Interferon Beta 1a IM, in Mexico and Colombia
- ClinicalTrials.gov ID
- NCT01556685
- Acronym / sponsor ID
- MATRIX / AVX-MEX-09-17
- Conditions
- Multiple Sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Oct 2011 (actual)
- First posted
- 16 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Avonex | Active comparator | Other: clinical and neurological evaluation, Other: Blood Sample, Genetic: Blood SampleApproximately 90 subjects treated with IFN beta 1a IM 30μg |
| Group 2 Jumtab | Active comparator | Other: clinical and neurological evaluation, Other: Blood Sample, Genetic: Blood SampleApproximately 90 subjects treated with IFN beta 1a IM biosimilar |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- To be eligible for entry into this study, candidates must meet all of the following eligibility criteria at the time of selection:
Key exclusion criteria (6 listed)
- Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of selection:
- NOTE: subjects may receive investigational symptomatic therapies for MS at any time prior to evaluation period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical and neurological evaluationThe day of the usual IFN beta 1a IM injection | Other | Group 1 Avonex, Group 2 Jumtab |
| Blood SampleFor evaluation of interferon-related Nab | Other | Group 1 Avonex, Group 2 Jumtab |
| Blood Samplegenetic evaluation - predisposition to Nab generation | Genetic | Group 1 Avonex, Group 2 Jumtab |
Primary outcome
Neutralizing antibodies to Interferon beta 1a IM (Avonex) or IFN beta 1a IM biosimilar
Time frame: Day 1
Percentage of patients with interferon induced Nabs measured in luciferase test
Time frame: Day 1
neutralizing antibodies to IFN beta 1a IM (Avonex) or IFN beta 1a IM biosimilar formulation (Jumtab)
Time frame: 1 day
Percent of patients with interferon induced neutralizing antibodies measured in a luciferase test
Time frame: 1 day
9 secondary outcomes
Rate and duration of corticosteroid use for relapse
Time frame: Day 1
Need and duration of hospitalization for relapse
Time frame: Day 1
Genetic profile of patients with relation to their predisposition to Nab development
Time frame: 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
Genetic profile of population with relation to predisposition to Nab generation
Time frame: Day 1
Rate/ duration of corticosteroid use for relapse
Time frame: 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
Genetic profile of patients with relation to the predisposition to Nab development
Time frame: 1 day
Interferon activity will be tested by neopterin protein activation before and after injection
Time frame: 48-72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing clinical and neurological evaluation and Blood Sample in people with Multiple Sclerosis, run by Biogen at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutralizing antibodies to Interferon beta 1a IM (Avonex) or IFN beta 1a IM biosimilar (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2013.