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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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