Avonex PEN Satisfaction and Patients Experience Clinical Trial

Multiple Sclerosis Clinical Trial

— ASPECT  

Official title:

An Open-Label, Survey-Based, Multicenter Study to Determine Patient Satisfaction With Single-Use Prefilled Avonex® PEN Autoinjector in Multiple Sclerosis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366040
• Other study ID #: AVX-CAN-11-08
• Status: Completed
• Phase: N/A
• First received: June 2, 2011
• Last updated: September 12, 2013
• Start date: June 2011
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

This is an open-label, multicenter, survey-based study to determine subject satisfaction with using the single-use autoinjector for the delivery of AVONEX PS. Enrollment will consist of 200 subjects in a single cohort who have been prescribed AVONEX PEN in accord with its Product Monograph. All subjects must be experienced AVONEX PS users (i.e., using it for at least 12 weeks without any support person to help with the injections administered in the vastus lateralis) and enrolled in MS AllianceTM program (hereinafter, MS Alliance). The clinic nurse investigator will instruct the patient on the correct method of using AVONEX PEN and the first injection with Autoinjector, using the subject's own supply, will be completed in the clinic, with the clinic nurse investigator present. All further injections of AVONEX PEN will be self-administered at home. The subjects will complete the first set of questionnaires, including Subject Satisfaction Questionnaire, Ease of Use Grading Scale and the Autoinjector Instructions Grading Scale, within 10 minutes after the first injection at the clinic, and will be given another set of questionnaires to be completed at home within 10 minutes following the last study injection 2 months later, provided the subjects still continue to self-administer their AVONEX PEN. The first set of questionnaires will be left with the clinic nurse investigator to be sent to the CRO by fax or e-mail, while the second set will need to be mailed to the CRO by study subjects using the provided self-addressed, postage-paid envelope.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Must give written informed consent. If required by local law, candidates must also authorize the release and use of Protected Health Information (PHI)

• Must be 18 to 65 years old, inclusive, at the time of informed consent

• Must be on AVONEX PS for at least 12 consecutive weeks

• Must be self-injecting AVONEX PS at the vastus lateralis site without any help, with or without use of Personal Injector

• Must be prescribed AVONEX PEN as per local labeling (Product Monograph) and enrolled in MS Alliance

• Must be able to physically demonstrate use of the Autoinjector device and be able to self-administer the injections

• Must be able to understand and comply with the protocol

Exclusion Criteria:

• Female subjects considering becoming pregnant while in the study or who are currently pregnant or breast-feeding

• Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrollment

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
Canada	Foothills Medical Center	Calgary	Alberta
Canada	Clinique Neuro-Outaouais	Gatineau	Quebec
Canada	Neuro Rive-Sud	Greenfield Park	Quebec
Canada	Norfolk Medical Clinic	Guelph	Ontario
Canada	Dalhousie MS Research Unit	Halifax	Nova Scotia
Canada	London Health Sciences Centre	London	Ontario
Canada	IRDPQ	Quebec City	Quebec
Canada	Saint John Regional Hospital	Saint John	New Brunswick
Canada	MUN Hospital	St. John's, Newfoundland and Labrador	Newfoundland and Labrador
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction		2 months	No
Secondary	Ease of use grading scale		2 months	No
Secondary	Autoinjector instructions grading scale		2 months	No