Clinical trial NCT01405872: Persistence, Adherence, Quality of Life, and Treatment Satisfaction With Avonex® PEN™.
Official title: An Observational Study to Assess Persistence, Adherence, Quality of Life, and Treatment Satisfaction in Patients Beginning Therapy With the Avonex® PEN™.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2011-07-29
Enrollment: 270
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multiple Sclerosis patients who have made the decision, along with their health care provider, to begin therapy with Avonex PEN.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: Tolerability of Avonex PEN as measured by Injection Site Pain
timeFrame: Months 3, 6, and 12
measure: Patient Quality of Life as measured by the EuroQol 5 domain (EQ-5D) Questionnaire
timeFrame: Months 3, 6, and 12
measure: Clarity of directions for use of the Avonex PEN as measured by the Avonex PEN Instruction Grading Scale
timeFrame: Month 3
measure: Ease of use and patient's assessment of the injection procedure with the Avonex PEN as measured by Ease of Use Grading Scale
timeFrame: Months 3, 6, and 12
measure: Patient reported adherence as measured by number of doses missed
timeFrame: Over the first 6 months and during Months 6 &amp; 12
measure: Physician reported persistence as measured by number of patients still on therapy
timeFrame: Month 6
measure: Patient reported satisfaction with the Avonex PEN as measured by the Patient Satisfaction Questionnaire
timeFrame: Months 3, 6 and 12
measure: Patient reported fear of injection using the Fear of Injection Scale
timeFrame: Months 3, 6 and 12
measure: Percent of patients switching from caregiver to self-injection
timeFrame: Months 3, 6, and 12
measure: Tolerability of Avonex PEN as measured by Injection Site Reaction
timeFrame: Months 3, 6 and 12
measure: Ease of use and patient's assessment of the injection procedure with the Avonex PEN as measured by Patient Assessment of Injection Procedure
timeFrame: Months 3, 6 and 12
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Research Site
city: Holstebro
country: Denmark
facility: Research Site
city: Naestved
country: Denmark
facility: Research Site
city: Amiens
country: France
facility: Research Site
city: Clermont Ferrand
country: France
facility: Research Site
city: Créteil
country: France
facility: Research Site
city: Nancy
country: France
facility: Research Site
city: Rouen
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Aachen
country: Germany
facility: Research Site
city: Bamberg
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Eisenach
country: Germany
facility: Research Site
city: Erbach
country: Germany
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Heidenheim
country: Germany
facility: Research Site
city: Herford
country: Germany
facility: Research Site
city: Itzehoe
country: Germany
facility: Research Site
city: Kastellaun
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Nagold
country: Germany
facility: Research Site
city: Potsdam
country: Germany
facility: Research Site
city: Regensburg
country: Germany
facility: Research Site
city: Rottweil
country: Germany
facility: Research Site
city: Ruedersdorf
country: Germany
facility: Research Site
city: Schwendi
country: Germany
facility: Research Site
city: Siegen
country: Germany
facility: Research Site
city: Sinsheim
country: Germany
facility: Research Site
city: Stade
country: Germany
facility: Research Site
city: Weil am Rhein
country: Germany
facility: Research Site
city: Weisbaden
country: Germany
facility: Research Site
city: Wolfratshausen
country: Germany
facility: Research Site
city: Eindhoven
country: Netherlands
facility: Research Site
city: Heerlen
country: Netherlands
facility: Research Site
city: Hertogenbosch
country: Netherlands
facility: Research Site
city: Leeuwarden
country: Netherlands
facility: Research Site
city: Sittard
country: Netherlands
facility: Research Site
city: Bergen
country: Norway
facility: Research Site
city: Drammem
country: Norway
facility: Research Site
city: Førde
country: Norway
facility: Research Site
city: Molde
country: Norway
facility: Research Site
city: Tønsberg
country: Norway
facility: Research Site
city: Amadora
country: Portugal
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Helsingborg
country: Sweden
facility: Research Site
city: Karlstad
country: Sweden
facility: Research Site
city: Linköping
country: Sweden
facility: Research Site
city: Norrköping
country: Sweden
facility: Research Site
city: Skövde
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Trollhättan
country: Sweden
facility: Research Site
city: Lugano
country: Switzerland
facility: Research Site
city: Luzern
country: Switzerland
facility: Research Site
city: Sion
country: Switzerland
facility: Research Site
city: St. Gallen
country: Switzerland
facility: Research Site
city: Dundee
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Hammersmith
country: United Kingdom
facility: Research Site
city: Haywards Heath
country: United Kingdom
facility: Research Site
city: Irvine
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.