Canadian Avonex PEN Productivity Study (CAPPS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01489748
First received: December 1, 2011
Last updated: February 18, 2015
Last verified: February 2015
  Purpose

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).


Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Change from Baseline in work capacity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Number of participants with hospital and emergency episodes of care [ Time Frame: -1 year, 1 year ] [ Designated as safety issue: No ]
  • Number of missed injections [ Time Frame: 1 month, 1 year, 2 years ] [ Designated as safety issue: No ]
  • Number of participants who discontinued treatment [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]
  • Change from Baseline in Global Quality of life score [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]
    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.

  • Change from Baseline in participants' satisfaction with the device [ Time Frame: 1 month, 1 year, 2 years ] [ Designated as safety issue: No ]
    Participant satisfaction will be measured using a 10-item satisfaction questionnaire.

  • Change from Baseline in ease of use of the device [ Time Frame: 1 month, 1 year, 2 years ] [ Designated as safety issue: No ]
    Ease of use will be assessed on a scale from 0 (extremely difficult) to 10 (extremely easy).

  • Number of participants with injection site reactions (ISRs) [ Time Frame: 1 month, 1 year, 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 111
Study Start Date: March 2012
Study Completion Date: December 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01489748

Locations
Canada, Ontario
Central Contact
Burlington, Ontario, Canada
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01489748     History of Changes
Other Study ID Numbers: CAN-AVX-11-10239
Study First Received: December 1, 2011
Last Updated: February 18, 2015
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Multiple Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on March 26, 2015