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Completed

NCT Number: NCT01489748

Canadian Avonex PEN Productivity Study

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).

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Central Contact

Burlington, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

Primary outcomes

  1. Change from Baseline in work capacity

    Time frame: 2 years

    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.

Secondary outcomes

  1. Number of participants with hospital and emergency episodes of care

    Time frame: -1 year, 1 year

  2. Number of missed injections

    Time frame: 1 month, 1 year, 2 years

  3. Number of participants who discontinued treatment

    Time frame: 1 year, 2 years

  4. Change from Baseline in Global Quality of life score

    Time frame: 1 year, 2 years

    Quality of life will be assessed by a Multiple Sclerosis Quality of Life (MSQOL) questionnaire. This 54-item questionnaire addresses overall health and daily activities.

  5. Change from Baseline in participants' satisfaction with the device

    Time frame: 1 month, 1 year, 2 years

    Participant satisfaction will be measured using a 10-item satisfaction questionnaire.

  6. Change from Baseline in ease of use of the device

    Time frame: 1 month, 1 year, 2 years

    Ease of use will be assessed on a scale from 0 (extremely difficult) to 10 (extremely easy).

  7. Number of participants with injection site reactions (ISRs)

    Time frame: 1 month, 1 year, 2 years

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

An Open-Label, Observational, Multicenter Study to Evaluate the Impact of AVONEX PEN Autoinjector Therapy on Work Capacity of Multiple Sclerosis Patients in Canada

Acronym: CAPPS

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 12, 2011
Registry last updated
Feb 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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