Persistence, Adherence, Quality of Life, and Treatment Satisfaction With Avonex® PEN™.
PERSIST
An Observational Study to Assess Persistence, Adherence, Quality of Life, and Treatment Satisfaction in Patients Beginning Therapy With the Avonex® PEN™.
1 other identifier
observational
270
10 countries
64
Brief Summary
The primary objective of the study is to determine physician reported persistence with the Avonex PEN at Month 12/End of Study as well as determining factors associated with persistence. The secondary objectives for this study are as follows: To evaluate the tolerability for treatment administration of the Avonex PEN at Months 3, 6, and 12; To evaluate patient quality of life (QoL) while using the Avonex PEN for treatment administration at Months 3, 6, and 12; To evaluate clarity of directions for use of the Avonex PEN at Month 3; To evaluate ease of use and the patient's assessment of the injection procedure with the Avonex PEN at Months 3, 6, and 12; To evaluate patient reported adherence at Months 6 and 12; To evaluate physician reported persistence at Month 6; To evaluate overall patient satisfaction with the use of the Avonex PEN for treatment administration at Months 3, 6, and 12; To evaluate patient reported fear of injection at Months 3, 6, and 12; and To evaluate the percentage of patients switching from caregiver to self-injection at Months 3, 6, and 12.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2011
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2011
CompletedFirst Posted
Study publicly available on registry
July 29, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedSeptember 9, 2014
September 1, 2014
2 years
July 28, 2011
September 5, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Persistence with Avonex PEN therapy at Month 12/End of Study as measured by the percentage of patients remaining on therapy at Month 12/End of Study as reported by a physician.
12 months
Secondary Outcomes (11)
Tolerability of Avonex PEN as measured by Injection Site Pain
Months 3, 6, and 12
Patient Quality of Life as measured by the EuroQol 5 domain (EQ-5D) Questionnaire
Months 3, 6, and 12
Clarity of directions for use of the Avonex PEN as measured by the Avonex PEN Instruction Grading Scale
Month 3
Ease of use and patient's assessment of the injection procedure with the Avonex PEN as measured by Ease of Use Grading Scale
Months 3, 6, and 12
Patient reported adherence as measured by number of doses missed
Over the first 6 months and during Months 6 & 12
- +6 more secondary outcomes
Interventions
Participants receive Avonex PEN commercially prescribed according to the local prescribing information.
Eligibility Criteria
Multiple Sclerosis patients who have made the decision, along with their health care provider, to begin therapy with Avonex PEN.
You may qualify if:
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent
- Must satisfy the locally approved therapeutic indications for the Avonex PEN
- Decision to treat with Avonex PEN must precede enrollment
- Must have no more than two (2) injections with the Avonex PEN prior to enrollment
You may not qualify if:
- Inability to comply with study requirements
- Other unspecified reasons that, in the opinion of the investigator or Biogen Idec, make the patient unsuitable for enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (64)
Research Site
Glostrup Municipality, Denmark
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Holstebro, Denmark
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Næstved, Denmark
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Amiens, France
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Clermont-Ferrand, France
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Créteil, France
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Nancy, France
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Rouen, France
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Strasbourg, France
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Aachen, Germany
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Bamberg, Germany
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Berlin, Germany
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Dresden, Germany
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Eisenach, Germany
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Erbach im Odenwald, Germany
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Freiburg im Breisgau, Germany
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Hamburg, Germany
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Heidenheim, Germany
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Herford, Germany
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Itzehoe, Germany
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Kastellaun, Germany
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München, Germany
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Nagold, Germany
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Potsdam, Germany
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Regensburg, Germany
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Rottweil, Germany
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Rüdersdorf, Germany
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Schwendi, Germany
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Siegen, Germany
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Sinsheim, Germany
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Stade, Germany
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Weil am Rhein, Germany
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Weisbaden, Germany
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Wolfratshausen, Germany
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's-Hertogenbosch, Netherlands
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Eindhoven, Netherlands
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Heerlen, Netherlands
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Leeuwarden, Netherlands
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Sittard, Netherlands
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Bergen, Norway
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Drammem, Norway
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Førde, Norway
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Molde, Norway
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Tønsberg, Norway
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Amadora, Portugal
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Košice, Slovakia
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Helsingborg, Sweden
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Karlstad, Sweden
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Linköping, Sweden
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Norrköping, Sweden
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Skövde, Sweden
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Stockholm, Sweden
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Trollhättan, Sweden
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Lucerne, Switzerland
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Lugano, Switzerland
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Sankt Gallen, Switzerland
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Sion, Switzerland
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Dundee, United Kingdom
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Glasgow, United Kingdom
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Hammersmith, United Kingdom
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Haywards Heath, United Kingdom
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Irvine, United Kingdom
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Leicester, United Kingdom
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Sheffield, United Kingdom
Related Publications (1)
Hupperts R, Becker V, Friedrich J, Gobbi C, Salgado AV, Sperling B, You X. Multiple sclerosis patients treated with intramuscular IFN-beta-1a autoinjector in a real-world setting: prospective evaluation of treatment persistence, adherence, quality of life and satisfaction. Expert Opin Drug Deliv. 2015 Jan;12(1):15-25. doi: 10.1517/17425247.2015.989209. Epub 2014 Nov 28.
PMID: 25430947DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2011
First Posted
July 29, 2011
Study Start
September 1, 2011
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
September 9, 2014
Record last verified: 2014-09