Avonex PEN Satisfaction and Patients Experience Clinical Trial (ASPECT)

An Open-Label, Survey-Based, Multicenter Study to Determine Patient Satisfaction With Single-Use Prefilled Avonex® PEN Autoinjector in Multiple Sclerosis Patients

This is an open-label, multicenter, survey-based study to determine subject satisfaction with using the single-use autoinjector for the delivery of AVONEX PS. Enrollment will consist of 200 subjects in a single cohort who have been prescribed AVONEX PEN in accord with its Product Monograph. All subjects must be experienced AVONEX PS users (i.e., using it for at least 12 weeks without any support person to help with the injections administered in the vastus lateralis) and enrolled in MS AllianceTM program (hereinafter, MS Alliance). The clinic nurse investigator will instruct the patient on the correct method of using AVONEX PEN and the first injection with Autoinjector, using the subject's own supply, will be completed in the clinic, with the clinic nurse investigator present. All further injections of AVONEX PEN will be self-administered at home. The subjects will complete the first set of questionnaires, including Subject Satisfaction Questionnaire, Ease of Use Grading Scale and the Autoinjector Instructions Grading Scale, within 10 minutes after the first injection at the clinic, and will be given another set of questionnaires to be completed at home within 10 minutes following the last study injection 2 months later, provided the subjects still continue to self-administer their AVONEX PEN. The first set of questionnaires will be left with the clinic nurse investigator to be sent to the CRO by fax or e-mail, while the second set will need to be mailed to the CRO by study subjects using the provided self-addressed, postage-paid envelope.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis

• Study Type: Observational
• Enrollment (Actual): 89

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Medical Center
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Saint John Regional Hospital
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Newfoundland and Labrador, Canada, A1B 3V6
      • MUN Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 4K4
      • Dalhousie MS Research Unit
  • Ontario
    • Guelph, Ontario, Canada, N1H 4J4
      • Norfolk Medical Clinic
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
  • Quebec
    • Gatineau, Quebec, Canada, J9J 0A5
      • Clinique Neuro-Outaouais
    • Greenfield Park, Quebec, Canada, J4V 2J2
      • Neuro Rive-Sud
    • Quebec City, Quebec, Canada, G1M 2S8
      • IRDPQ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Multiple Sclerosis (MS) subjects between the ages of 18 and 65, inclusive, who have been treated with AVONEX® PS for at least 12 weeks prior to study entry.

Description

Inclusion Criteria:

• 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 18 to 65 years old, inclusive, at the time of informed consent
• Must be on AVONEX PS for at least 12 consecutive weeks
• Must be self-injecting AVONEX PS at the vastus lateralis site without any help, with or without use of Personal Injector
• Must be prescribed AVONEX PEN as per local labeling (Product Monograph) and enrolled in MS Alliance
• Must be able to physically demonstrate use of the Autoinjector device and be able to self-administer the injections
• 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
• Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrollment

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient satisfaction	2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Ease of use grading scale	2 months
Autoinjector instructions grading scale	2 months

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: June 2, 2011
• First Submitted That Met QC Criteria: June 2, 2011
• First Posted (Estimate): June 3, 2011

Study Record Updates

• Last Update Posted (Estimate): September 16, 2013
• Last Update Submitted That Met QC Criteria: September 12, 2013
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Patient Satisfaction; Autoinjector; Avonex
• 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: AVX-CAN-11-08