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Completed

NCT Number: NCT01405872

Persistence, Adherence, Quality of Life, and Treatment Satisfaction With 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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Glostrup Municipality, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AVONEX PEN

Other

Participants receive Avonex PEN commercially prescribed according to the local prescribing information.

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.

    Time frame: 12 months

Secondary outcomes

  1. Tolerability of Avonex PEN as measured by Injection Site Pain

    Time frame: Months 3, 6, and 12

  2. Patient Quality of Life as measured by the EuroQol 5 domain (EQ-5D) Questionnaire

    Time frame: Months 3, 6, and 12

  3. Clarity of directions for use of the Avonex PEN as measured by the Avonex PEN Instruction Grading Scale

    Time frame: Month 3

  4. 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

  5. Patient reported adherence as measured by number of doses missed

    Time frame: Over the first 6 months and during Months 6 & 12

  6. Physician reported persistence as measured by number of patients still on therapy

    Time frame: Month 6

  7. Patient reported satisfaction with the Avonex PEN as measured by the Patient Satisfaction Questionnaire

    Time frame: Months 3, 6 and 12

  8. Patient reported fear of injection using the Fear of Injection Scale

    Time frame: Months 3, 6 and 12

  9. Percent of patients switching from caregiver to self-injection

    Time frame: Months 3, 6, and 12

  10. Tolerability of Avonex PEN as measured by Injection Site Reaction

    Time frame: Months 3, 6 and 12

  11. 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

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

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

Acronym: PERSIST

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 29, 2011
Registry last updated
Sep 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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