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

NCT01405872 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 270

Last updated 2014-09-09

No results posted yet for this study

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.

Conditions

Interventions

OTHER

AVONEX PEN

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Denmark
  • France
  • Germany
  • Netherlands
  • Norway
  • Portugal
  • Slovakia
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01405872 on ClinicalTrials.gov