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

Multiple Sclerosis Clinical Trial

— MATRIX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556685
• Other study ID #: AVX-MEX-09-17
• Status: Completed
• Phase: Phase 4
• First received: October 20, 2011
• Last updated: September 12, 2013
• Start date: March 2011

Study information

• Verified date: March 2012
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosMexico: Ministry of Health
• Study type: Interventional

Clinical 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 with relapsing MS related to antibody status and treatment.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

Other:
• clinical and neurological evaluation
The day of the usual IFN beta 1a IM injection
• Blood Sample
For evaluation of interferon-related Nab

Genetic:
• Blood Sample
genetic evaluation - predisposition to Nab generation

Locations

Country	Name	City	State
Colombia	Research Site	Bogota
Mexico	Research Site	Leon	Guanajuato

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

Colombia,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neutralizing antibodies to Interferon beta 1a IM (Avonex) or IFN beta 1a IM biosimilar		Day 1	No
Primary	Percentage of patients with interferon induced Nabs measured in luciferase test		Day 1	No
Primary	neutralizing antibodies to IFN beta 1a IM (Avonex) or IFN beta 1a IM biosimilar formulation (Jumtab)		1 day	No
Primary	Percent of patients with interferon induced neutralizing antibodies measured in a luciferase test		1 day	No
Secondary	Rate and duration of corticosteroid use for relapse		Day 1	No
Secondary	Need and duration of hospitalization for relapse		Day 1	No
Secondary	Genetic profile of patients with relation to their predisposition to Nab development		Day 1	No
Secondary	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	No
Secondary	Genetic profile of population with relation to predisposition to Nab generation		Day 1	No
Secondary	Rate/ duration of corticosteroid use for relapse		measured up to 3 years prior to enrollment @ Day 1	No
Secondary	Need/ duration of hospitalization for relapse		measured up to 3 years prior to enrollment @ Day 1	No
Secondary	Genetic profile of patients with relation to the predisposition to Nab development		1 day	No
Secondary	Interferon activity will be tested by neopterin protein activation before and after injection		48-72 hours	No