Canadian Avonex PEN Productivity Study

Multiple Sclerosis Clinical Trial

— CAPPS  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01489748
• Other study ID #: CAN-AVX-11-10239
• Status: Completed
• Phase: N/A
• First received: December 1, 2011
• Last updated: February 18, 2015
• Start date: March 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
Canada	Central Contact	Burlington	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of participants with hospital and emergency episodes of care		-1 year, 1 year	No
Secondary	Number of missed injections		1 month, 1 year, 2 years	No
Secondary	Number of participants who discontinued treatment		1 year, 2 years	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Number of participants with injection site reactions (ISRs)		1 month, 1 year, 2 years	Yes