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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVONEX PEN | Other | Participants receive Avonex PEN commercially prescribed according to the local prescribing information. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of Avonex PEN as measured by Injection Site Pain | Months 3, 6, and 12 | |
| Patient Quality of Life as measured by the EuroQol 5 domain (EQ-5D) Questionnaire | Months 3, 6, and 12 | |
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Inclusion Criteria:
Exclusion Criteria:
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Multiple Sclerosis patients who have made the decision, along with their health care provider, to begin therapy with Avonex PEN.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Glostrup Municipality | Denmark | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25430947 | Derived | Hupperts R, Becker V, Friedrich J, Gobbi C, Salgado AV, Sperling B, You X. Multiple sclerosis patients treated with intramuscular IFN-beta-1a autoinjector in a real-world setting: prospective evaluation of treatment persistence, adherence, quality of life and satisfaction. Expert Opin Drug Deliv. 2015 Jan;12(1):15-25. doi: 10.1517/17425247.2015.989209. Epub 2014 Nov 28. |
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| 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 |
| Patient reported satisfaction with the Avonex PEN as measured by the Patient Satisfaction Questionnaire | 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 |
| Holstebro |
| Denmark |
| Research Site | Næstved | Denmark |
| Research Site | Amiens | France |
| Research Site | Clermont-Ferrand | France |
| Research Site | Créteil | France |
| Research Site | Nancy | France |
| Research Site | Rouen | France |
| Research Site | Strasbourg | France |
| Research Site | Aachen | Germany |
| Research Site | Bamberg | Germany |
| Research Site | Berlin | Germany |
| Research Site | Dresden | Germany |
| Research Site | Eisenach | Germany |
| Research Site | Erbach im Odenwald | Germany |
| Research Site | Freiburg im Breisgau | Germany |
| Research Site | Hamburg | Germany |
| Research Site | Heidenheim | Germany |
| Research Site | Herford | Germany |
| Research Site | Itzehoe | Germany |
| Research Site | Kastellaun | Germany |
| Research Site | München | Germany |
| Research Site | Nagold | Germany |
| Research Site | Potsdam | Germany |
| Research Site | Regensburg | Germany |
| Research Site | Rottweil | Germany |
| Research Site | Rüdersdorf | Germany |
| Research Site | Schwendi | Germany |
| Research Site | Siegen | Germany |
| Research Site | Sinsheim | Germany |
| Research Site | Stade | Germany |
| Research Site | Weil am Rhein | Germany |
| Research Site | Weisbaden | Germany |
| Research Site | Wolfratshausen | Germany |
| Research Site | 's-Hertogenbosch | Netherlands |
| Research Site | Eindhoven | Netherlands |
| Research Site | Heerlen | Netherlands |
| Research Site | Leeuwarden | Netherlands |
| Research Site | Sittard | Netherlands |
| Research Site | Bergen | Norway |
| Research Site | Drammem | Norway |
| Research Site | Førde | Norway |
| Research Site | Molde | Norway |
| Research Site | Tønsberg | Norway |
| Research Site | Amadora | Portugal |
| Research Site | Košice | Slovakia |
| Research Site | Helsingborg | Sweden |
| Research Site | Karlstad | Sweden |
| Research Site | Linköping | Sweden |
| Research Site | Norrköping | Sweden |
| Research Site | Skövde | Sweden |
| Research Site | Stockholm | Sweden |
| Research Site | Trollhättan | Sweden |
| Research Site | Lucerne | Switzerland |
| Research Site | Lugano | Switzerland |
| Research Site | Sankt Gallen | Switzerland |
| Research Site | Sion | Switzerland |
| Research Site | Dundee | United Kingdom |
| Research Site | Glasgow | United Kingdom |
| Research Site | Hammersmith | United Kingdom |
| Research Site | Haywards Heath | United Kingdom |
| Research Site | Irvine | United Kingdom |
| Research Site | Leicester | United Kingdom |
| Research Site | Sheffield | United Kingdom |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068556 | Interferon beta-1a |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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