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

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01556685
First received: October 20, 2011
Last updated: March 15, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
 Other: clinical and neurological evaluation
Other: Blood Sample
Genetic: Blood Sample
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
Official Title: Measuring Neutralizing Antibodies in the Patients Treated With Interferon Beta 1a IM, in Mexico and Colombia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Neutralizing antibodies to Interferon beta 1a IM (Avonex) or IFN beta 1a IM biosimilar [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Percentage of patients with interferon induced Nabs measured in luciferase test [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • neutralizing antibodies to IFN beta 1a IM (Avonex) or IFN beta 1a IM biosimilar formulation (Jumtab) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Percent of patients with interferon induced neutralizing antibodies measured in a luciferase test [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate and duration of corticosteroid use for relapse [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Need and duration of hospitalization for relapse [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Genetic profile of patients with relation to their predisposition to Nab development [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Genetic profile of population with relation to predisposition to Nab generation [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Rate/ duration of corticosteroid use for relapse [ Time Frame: measured up to 3 years prior to enrollment @ Day 1 ] [ Designated as safety issue: No ]
  • Need/ duration of hospitalization for relapse [ Time Frame: measured up to 3 years prior to enrollment @ Day 1 ] [ Designated as safety issue: No ]
  • Genetic profile of patients with relation to the predisposition to Nab development [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Interferon activity will be tested by neopterin protein activation before and after injection [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]

Enrollment: 180
Study Start Date: March 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1 Avonex
Approximately 90 subjects treated with IFN beta 1a IM 30μg
 Other: clinical and neurological evaluation
The day of the usual IFN beta 1a IM injection
Other: Blood Sample
For evaluation of interferon-related Nab
Genetic: Blood Sample
genetic evaluation - predisposition to Nab generation
Active Comparator: Group 2 Jumtab
Approximately 90 subjects treated with IFN beta 1a IM biosimilar
 Other: clinical and neurological evaluation
The day of the usual IFN beta 1a IM injection
Other: Blood Sample
For evaluation of interferon-related Nab
Genetic: Blood Sample
genetic evaluation - predisposition to Nab generation

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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556685

Locations
Colombia
Research Site
Bogota, Colombia
Mexico
Research Site
Leon, Guanajuato, Mexico
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Regine Buffels, MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT01556685     History of Changes
Other Study ID Numbers: AVX-MEX-09-17
Study First Received: October 20, 2011
Last Updated: March 15, 2012
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Mexico: Ministry of Health

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
 Interferons
Interferon beta 1a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on May 23, 2013