Persistence, Adherence, Quality of Life, and Treatment Satisfaction With Avonex® PEN™. (PERSIST)

September 5, 2014 updated by: Biogen

An Observational Study to Assess Persistence, Adherence, Quality of Life, and Treatment Satisfaction in Patients Beginning Therapy With the Avonex® PEN™.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup, Denmark
        • Research Site
      • Holstebro, Denmark
        • Research Site
      • Naestved, Denmark
        • Research Site
  • France
      • Amiens, France
        • Research Site
      • Clermont Ferrand, France
        • Research Site
      • Créteil, France
        • Research Site
      • Nancy, France
        • Research Site
      • Rouen, France
        • Research Site
      • Strasbourg, France
        • Research Site
  • Germany
      • Aachen, Germany
        • Research Site
      • Bamberg, Germany
        • Research Site
      • Berlin, Germany
        • Research Site
      • Dresden, Germany
        • Research Site
      • Eisenach, Germany
        • Research Site
      • Erbach, Germany
        • Research Site
      • Freiburg, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Heidenheim, Germany
        • Research Site
      • Herford, Germany
        • Research Site
      • Itzehoe, Germany
        • Research Site
      • Kastellaun, Germany
        • Research Site
      • München, Germany
        • Research Site
      • Nagold, Germany
        • Research Site
      • Potsdam, Germany
        • Research Site
      • Regensburg, Germany
        • Research Site
      • Rottweil, Germany
        • Research Site
      • Ruedersdorf, Germany
        • Research Site
      • Schwendi, Germany
        • Research Site
      • Siegen, Germany
        • Research Site
      • Sinsheim, Germany
        • Research Site
      • Stade, Germany
        • Research Site
      • Weil am Rhein, Germany
        • Research Site
      • Weisbaden, Germany
        • Research Site
      • Wolfratshausen, Germany
        • Research Site
  • Netherlands
      • Eindhoven, Netherlands
        • Research Site
      • Heerlen, Netherlands
        • Research Site
      • Hertogenbosch, Netherlands
        • Research Site
      • Leeuwarden, Netherlands
        • Research Site
      • Sittard, Netherlands
        • Research Site
  • Norway
      • Bergen, Norway
        • Research Site
      • Drammem, Norway
        • Research Site
      • Førde, Norway
        • Research Site
      • Molde, Norway
        • Research Site
      • Tønsberg, Norway
        • Research Site
  • Portugal
      • Amadora, Portugal
        • Research Site
  • Slovakia
      • Kosice, Slovakia
        • Research Site
  • Sweden
      • Helsingborg, Sweden
        • Research Site
      • Karlstad, Sweden
        • Research Site
      • Linköping, Sweden
        • Research Site
      • Norrköping, Sweden
        • Research Site
      • Skövde, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
      • Trollhättan, Sweden
        • Research Site
  • Switzerland
      • Lugano, Switzerland
        • Research Site
      • Luzern, Switzerland
        • Research Site
      • Sion, Switzerland
        • Research Site
      • St. Gallen, Switzerland
        • Research Site
  • United Kingdom
      • Dundee, United Kingdom
        • Research Site
      • Glasgow, United Kingdom
        • Research Site
      • Hammersmith, United Kingdom
        • Research Site
      • Haywards Heath, United Kingdom
        • Research Site
      • Irvine, United Kingdom
        • Research Site
      • Leicester, United Kingdom
        • Research Site
      • Sheffield, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Multiple Sclerosis patients who have made the decision, along with their health care provider, to begin therapy with Avonex PEN.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Tolerability of Avonex PEN as measured by Injection Site Pain
Time Frame: Months 3, 6, and 12
Months 3, 6, and 12
Patient Quality of Life as measured by the EuroQol 5 domain (EQ-5D) Questionnaire
Time Frame: Months 3, 6, and 12
Months 3, 6, and 12
Clarity of directions for use of the Avonex PEN as measured by the Avonex PEN Instruction Grading Scale
Time Frame: Month 3
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
Time Frame: Months 3, 6, and 12
Months 3, 6, and 12
Patient reported adherence as measured by number of doses missed
Time Frame: Over the first 6 months and during Months 6 & 12
Over the first 6 months and during Months 6 & 12
Physician reported persistence as measured by number of patients still on therapy
Time Frame: Month 6
Month 6
Patient reported satisfaction with the Avonex PEN as measured by the Patient Satisfaction Questionnaire
Time Frame: Months 3, 6 and 12
Months 3, 6 and 12
Patient reported fear of injection using the Fear of Injection Scale
Time Frame: Months 3, 6 and 12
Months 3, 6 and 12
Percent of patients switching from caregiver to self-injection
Time Frame: Months 3, 6, and 12
Months 3, 6, and 12
Tolerability of Avonex PEN as measured by Injection Site Reaction
Time Frame: Months 3, 6 and 12
Months 3, 6 and 12
Ease of use and patient's assessment of the injection procedure with the Avonex PEN as measured by Patient Assessment of Injection Procedure
Time Frame: Months 3, 6 and 12
Months 3, 6 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

July 28, 2011

First Submitted That Met QC Criteria

July 28, 2011

First Posted (Estimate)

July 29, 2011

Study Record Updates

Last Update Posted (Estimate)

September 9, 2014

Last Update Submitted That Met QC Criteria

September 5, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 108MS402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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