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

Biogen270 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

270

Conditions

Multiple Sclerosis

Interventions

AVONEX PENOTHER

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (64)

Research Site

Glostrup Municipality, Denmark

Research Site

Holstebro, Denmark

Research Site

Næstved, Denmark

Research Site

Amiens, France

Research Site

Clermont-Ferrand, France

Research Site

Créteil, France

Outcomes

Primary Outcomes

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

Tolerability of Avonex PEN as measured by Injection Site Pain

Time frame: 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

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

Time frame: 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

Patient reported adherence as measured by number of doses missed

Time frame: 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

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

Time frame: Months 3, 6 and 12

Patient reported fear of injection using the Fear of Injection Scale

Time frame: Months 3, 6 and 12

Percent of patients switching from caregiver to self-injection

Time frame: Months 3, 6, and 12

Tolerability of Avonex PEN as measured by Injection Site Reaction

Time frame: 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