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

Biogen

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Other: AVONEX PEN

Study type: Observational

Funder types: Industry

Identifiers

NCT01405872

108MS402

Details and patient eligibility

About

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.

Enrollment: 270 patients

Sex: All

Volunteers: No Healthy Volunteers

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