Avonex PEN Satisfaction and Patients Experience Clinical Trial (ASPECT)
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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 |
- Patient satisfaction [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- 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 |
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.
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| 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 | |
More Information
No publications provided
| Responsible Party: | Vladimir Migounov, MD/Senior Manager, Medical Affairs, Biogen Idec Canada Inc. |
| ClinicalTrials.gov Identifier: | NCT01366040 History of Changes |
| Other Study ID Numbers: | AVX-CAN-11-08 |
| Study First Received: | June 2, 2011 |
| Last Updated: | June 7, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Biogen Idec:
|
Patient Satisfaction Multiple Sclerosis Autoinjector Avonex |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |
Pathologic Processes Interferon beta 1a Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013