NCT01405872

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 270 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

• Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	AVONEX PEN	Participants receive Avonex PEN commercially prescribed according to the local prescribing information.

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2011-07-29
• Last updated: 2014-09-09

Locations

64 sites across 10 countries: Denmark, France, Germany, Netherlands, Norway, Portugal, Slovakia, Sweden, Switzerland, United Kingdom