NCT01556685

Brief 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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_4 multiple-sclerosis

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2011

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 16, 2012

Completed
Last Updated

September 16, 2013

Status Verified

March 1, 2012

Enrollment Period

7 months

First QC Date

October 20, 2011

Last Update Submit

September 12, 2013

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (4)

  • Neutralizing antibodies to Interferon beta 1a IM (Avonex) or IFN beta 1a IM biosimilar

    Day 1

  • Percentage of patients with interferon induced Nabs measured in luciferase test

    Day 1

  • neutralizing antibodies to IFN beta 1a IM (Avonex) or IFN beta 1a IM biosimilar formulation (Jumtab)

    1 day

  • Percent of patients with interferon induced neutralizing antibodies measured in a luciferase test

    1 day

Secondary Outcomes (9)

  • Rate and duration of corticosteroid use for relapse

    Day 1

  • Need and duration of hospitalization for relapse

    Day 1

  • Genetic 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

  • Genetic profile of population with relation to predisposition to Nab generation

    Day 1

  • +4 more secondary outcomes

Study Arms (2)

Group 1 Avonex

ACTIVE COMPARATOR

Approximately 90 subjects treated with IFN beta 1a IM 30μg

Other: clinical and neurological evaluationOther: Blood SampleGenetic: Blood Sample

Group 2 Jumtab

ACTIVE COMPARATOR

Approximately 90 subjects treated with IFN beta 1a IM biosimilar

Other: clinical and neurological evaluationOther: Blood SampleGenetic: Blood Sample

Interventions

clinical and neurological evaluationOTHER

The day of the usual IFN beta 1a IM injection

Group 1 AvonexGroup 2 Jumtab
Blood SampleOTHER

For evaluation of interferon-related Nab

Group 1 AvonexGroup 2 Jumtab

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Bogotá, Colombia

Location

Research Site

León, Guanajuato, Mexico

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2011

First Posted

March 16, 2012

Study Start

March 1, 2011

Primary Completion

October 1, 2011

Last Updated

September 16, 2013

Record last verified: 2012-03

Locations

ME(1)CO(1)