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Canadian Avonex PEN Productivity Study (CAPPS)

This study is currently recruiting participants.
Verified March 2012 by Biogen Idec
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01489748
First received: December 1, 2011
Last updated: June 14, 2012
Last verified: March 2012
History of Changes
  Purpose

This is a multicenter, observational, questionnaire-based study of patients starting on AVONEX PEN autoinjector, with each patient to be followed prospectively for approximately 2 years. This study is primarily designed to evaluate the impact of AVONEX PEN autoinjector on work capacity of patients 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 patients starting on AVONEX PEN autoinjector, as well as its 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:

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Effect of MS on patients' ability to work and perform regular activities, its change from baseline and its correlation rate with all secondary outcomes [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]
  • Patients drop-off rate [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]
  • Quality of life scores and their change from baseline [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]
  • Patients' satisfaction with the device and its change from baseline [ Time Frame: 1 month, 1 year, 2 years ] [ Designated as safety issue: No ]
  • Ease of use of the device and its change from baseline [ Time Frame: 1 month, 1 year, 2 years ] [ Designated as safety issue: No ]
  • Injection site reactions (ISRs) type and frequency as reported by healthcare professionals and patients to the Sponsor's adverse event (AE) reporting system [ Time Frame: 1 month, 1 year, 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: January 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 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 subjects who have been prescribed AVONEX PEN in accord with its labeling (Product Monograph). This will include subjects who are naïve to disease modifying therapies (DMTs) as well as those who are being switched from another injectable DMT.

Criteria

Inclusion Criteria:

  • Must be prescribed AVONEX PEN as per local labeling (Product Monograph) and enrolled in MS Alliance (MSA) program
  • Must be 18 to 50 years old, inclusive, at the time of informed consent
  • 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

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

Contacts
Contact: Medical Director 905-897-3254 vladimir.migounov@biogenidec.com

Locations
Canada, Ontario
Central Contact Recruiting
Burlington, Ontario, Canada
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Vladimir Migounov, MD/Senior Manager, Medical Affairs, Biogen Idec Canada Inc.
ClinicalTrials.gov Identifier: NCT01489748     History of Changes
Other Study ID Numbers: CAN-AVX-11-10239
Study First Received: December 1, 2011
Last Updated: June 14, 2012
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on May 22, 2013