Canadian Avonex PEN Productivity Study (CAPPS)

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

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).

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis

• Study Type: Observational
• Enrollment (Actual): 111

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Burlington, Ontario, Canada
      • Central Contact

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	1 year, 2 years
Change from Baseline in participants' satisfaction with the device	Participant satisfaction will be measured using a 10-item satisfaction questionnaire.	1 month, 1 year, 2 years
Change from Baseline in ease of use of the device	Ease of use will be assessed on a scale from 0 (extremely difficult) to 10 (extremely easy).	1 month, 1 year, 2 years
Number of participants with injection site reactions (ISRs)		1 month, 1 year, 2 years

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 1, 2011
• First Submitted That Met QC Criteria: December 8, 2011
• First Posted (Estimate): December 12, 2011

Study Record Updates

• Last Update Posted (Estimate): February 20, 2015
• Last Update Submitted That Met QC Criteria: February 18, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: CAN-AVX-11-10239