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Avonex PEN Satisfaction and Patients Experience Clinical Trial (ASPECT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01366040
First received: June 2, 2011
Last updated: September 12, 2013
Last verified: May 2012
  Purpose

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.


Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Open-Label, Survey-Based, Multicenter Study to Determine Patient Satisfaction With Single-Use Prefilled Avonex® PEN Autoinjector in Multiple Sclerosis Patients

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Patient satisfaction [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ease of use grading scale [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Autoinjector instructions grading scale [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 89
Study Start Date: June 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Multiple Sclerosis (MS) subjects between the ages of 18 and 65, inclusive, who have been treated with AVONEX® PS for at least 12 weeks prior to study entry.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366040

Locations
Canada, Alberta
Foothills Medical Center
Calgary, Alberta, Canada, T2N 2T9
Canada, New Brunswick
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
MUN Hospital
St. John's, Newfoundland and Labrador, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Dalhousie MS Research Unit
Halifax, Nova Scotia, Canada, B3H 4K4
Canada, Ontario
Norfolk Medical Clinic
Guelph, Ontario, Canada, N1H 4J4
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Clinique Neuro-Outaouais
Gatineau, Quebec, Canada, J9J 0A5
Neuro Rive-Sud
Greenfield Park, Quebec, Canada, J4V 2J2
IRDPQ
Quebec City, Quebec, Canada, G1M 2S8
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01366040     History of Changes
Other Study ID Numbers: AVX-CAN-11-08
Study First Received: June 2, 2011
Last Updated: September 12, 2013
Health Authority: Canada: Health Canada

Keywords provided by Biogen Idec:
Patient Satisfaction
Multiple Sclerosis
Autoinjector
Avonex

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014