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

Multiple Sclerosis Clinical Trial

— PERSIST  

Official title:

An Observational Study to Assess Persistence, Adherence, Quality of Life, and Treatment Satisfaction in Patients Beginning Therapy With the Avonex® PEN™.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01405872
• Other study ID #: 108MS402
• Status: Completed
• Phase: N/A
• First received: July 28, 2011
• Last updated: September 5, 2014
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: September 2014
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyNorway: Ethics CommitteeSwitzerland: SwissmedicPortugal: Ethics Committee for Clinical ResearchSweden: Regional Ethical Review BoardSlovakia: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

Other:
• AVONEX PEN
Participants receive Avonex PEN commercially prescribed according to the local prescribing information.

Locations

Country	Name	City	State
Denmark	Research Site	Glostrup
Denmark	Research Site	Holstebro
Denmark	Research Site	Naestved
France	Research Site	Amiens
France	Research Site	Clermont Ferrand
France	Research Site	Créteil
France	Research Site	Nancy
France	Research Site	Rouen
France	Research Site	Strasbourg
Germany	Research Site	Aachen
Germany	Research Site	Bamberg
Germany	Research Site	Berlin
Germany	Research Site	Dresden
Germany	Research Site	Eisenach
Germany	Research Site	Erbach
Germany	Research Site	Freiburg
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	Ruedersdorf
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
Netherlands	Research Site	Eindhoven
Netherlands	Research Site	Heerlen
Netherlands	Research Site	Hertogenbosch
Netherlands	Research Site	Leeuwarden
Netherlands	Research Site	Sittard
Norway	Research Site	Bergen
Norway	Research Site	Drammem
Norway	Research Site	Førde
Norway	Research Site	Molde
Norway	Research Site	Tønsberg
Portugal	Research Site	Amadora
Slovakia	Research Site	Kosice
Sweden	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
Switzerland	Research Site	Lugano
Switzerland	Research Site	Luzern
Switzerland	Research Site	Sion
Switzerland	Research Site	St. Gallen
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Netherlands,  Norway,  Portugal,  Slovakia,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Tolerability of Avonex PEN as measured by Injection Site Pain		Months 3, 6, and 12	Yes
Secondary	Patient Quality of Life as measured by the EuroQol 5 domain (EQ-5D) Questionnaire		Months 3, 6, and 12	No
Secondary	Clarity of directions for use of the Avonex PEN as measured by the Avonex PEN Instruction Grading Scale		Month 3	No
Secondary	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	No
Secondary	Patient reported adherence as measured by number of doses missed		Over the first 6 months and during Months 6 & 12	No
Secondary	Physician reported persistence as measured by number of patients still on therapy		Month 6	No
Secondary	Patient reported satisfaction with the Avonex PEN as measured by the Patient Satisfaction Questionnaire		Months 3, 6 and 12	No
Secondary	Patient reported fear of injection using the Fear of Injection Scale		Months 3, 6 and 12	No
Secondary	Percent of patients switching from caregiver to self-injection		Months 3, 6, and 12	No
Secondary	Tolerability of Avonex PEN as measured by Injection Site Reaction		Months 3, 6 and 12	Yes
Secondary	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	No