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

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT01405872
• Lead Sponsor: Biogen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-28
• Study First Submitted QC: 2011-07-28
• Study First Posted: 2011-07-29
• Study Start: 2011-09
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-05
• Last Update Posted: 2014-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇬🇧 Sheffield, United Kingdom