NCT01489748

Brief Summary

This study is primarily designed to evaluate the impact of AVONEX PEN autoinjector on work capacity of participants with multiple sclerosis (MS) starting on this device. This study will also evaluate as secondary endpoints various patient-reported outcomes over the short-term (1 month), including adherence, treatment satisfaction and convenience, and the long-term (12 and 24 months), including adherence, persistence, quality of life (QOL), treatment satisfaction and convenience. It will also assess health resource utilization by MS participants starting on AVONEX PEN autoinjector, as well as overall safety/tolerability, and will correlate all secondary outcomes with the primary (i.e., work capacity).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 12, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 20, 2015

Status Verified

February 1, 2015

Enrollment Period

2.6 years

First QC Date

December 1, 2011

Last Update Submit

February 18, 2015

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in work capacity

    Work capacity will be assessed by a telephone-based survey which consists of 10 questions asking participant's about the effect of MS on their ability to work and perform regular activities.

    2 years

Secondary Outcomes (7)

  • Number of participants with hospital and emergency episodes of care

    -1 year, 1 year

  • Number of missed injections

    1 month, 1 year, 2 years

  • Number of participants who discontinued treatment

    1 year, 2 years

  • Change from Baseline in Global Quality of life score

    1 year, 2 years

  • Change from Baseline in participants' satisfaction with the device

    1 month, 1 year, 2 years

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Enrollment will consist of approximately 500 participants who have been prescribed AVONEX PEN in accord with its labeling (Product Monograph). This will include participants who are naïve to disease modifying therapies (DMTs) as well as those who are being switched from another injectable DMT.

You may qualify if:

  • Must be prescribed AVONEX PEN as per local labeling (Product Monograph) and enrolled in MS Alliance (MSA) program
  • If being switched from another DMT, must be on this DMT for at least 6 months
  • Last DMT the subject is switched from must be injectable
  • Must be able to physically demonstrate use of the AVONEX PEN autoinjector device and be able to self-administer the injections
  • Must give written informed consent. If required by local law, candidates must also authorize the release and use of protected health information (PHI)
  • Must be able to understand and comply with the protocol

You may not qualify if:

  • Female subjects considering becoming pregnant while in the study or who are currently pregnant or breast-feeding
  • Current enrollment in any investigational study involving drug, biologic or non-drug therapy
  • Participation in other clinical studies within the past 6 months
  • Treatment with immunosuppressive regimens (e.g. cyclophosphamide, azathioprine, methotrexate or mitoxantrone) or with intravenous immunoglobulin (IVIg) in the last 6 months
  • The most recent DMT the subject is switched from is non-injectable (i.e., oral)
  • Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Contact

Burlington, Ontario, Canada

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2011

First Posted

December 12, 2011

Study Start

March 1, 2012

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

February 20, 2015

Record last verified: 2015-02

Locations

CA(1)