Multiple Sclerosis
Conditions
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.
Interventions
OTHERAVONEX PEN
Participants receive Avonex PEN commercially prescribed according to the local prescribing information.
Sponsors
Biogen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Patient Quality of Life as measured by the EuroQol 5 domain (EQ-5D) Questionnaire | 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 reported adherence as measured by number of doses missed | Over the first 6 months and during Months 6 & 12 |
| Physician reported persistence as measured by number of patients still on therapy | Month 6 |
| Tolerability of Avonex PEN as measured by Injection Site Pain | Months 3, 6, and 12 |
| 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 |
| Tolerability of Avonex PEN as measured by Injection Site Reaction | 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 |
| Patient reported satisfaction with the Avonex PEN as measured by the Patient Satisfaction Questionnaire | Months 3, 6 and 12 |
Countries
Denmark, France, Germany, Netherlands, Norway, Portugal, Slovakia, Sweden, Switzerland, United Kingdom
Outcome results
None listed