Multiple SclerosisASPECTNCT01366040
Avonex PEN Satisfaction and Patients Experience Clinical Trial
An observational study of Multiple Sclerosis, run by Biogen at 10 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 89 participants
- Where
- 10 sitesCanada
- Study dates
- Jun 2011to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Canada10 sites
Foothills Medical Center
Calgary, Alberta, T2N 2T9
Clinique Neuro-Outaouais
Gatineau, Quebec, J9J 0A5
Neuro Rive-Sud
Greenfield Park, Quebec, J4V 2J2
Norfolk Medical Clinic
Guelph, Ontario, N1H 4J4
Dalhousie MS Research Unit
Halifax, Nova Scotia, B3H 4K4
London Health Sciences Centre
London, Ontario, N6A 5A5
IRDPQ
Québec, Quebec, G1M 2S8
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
MUN Hospital
Saint John's, Newfoundland and Labrador, Newfoundland and Labrador, A1B 3V6
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
About this study
Official title: An Open-Label, Survey-Based, Multicenter Study to Determine Patient Satisfaction With Single-Use Prefilled Avonex® PEN Autoinjector in Multiple Sclerosis Patients
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.
- Conditions
- Multiple Sclerosis
- Keywords
- Patient Satisfaction, Multiple Sclerosis, Autoinjector, Avonex
- Medical subject headings
- Multiple Sclerosis, Patient Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Measured: 2 months
Secondary outcomes (2)
Ease of use grading scale
Measured: 2 months
Autoinjector instructions grading scale
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366040
- Sponsor's protocol ID
- AVX-CAN-11-08
- Acronym
- ASPECT
- Status last verified
- May 2012
- First submitted
- 2 Jun 2011
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Survey-Based, Multicenter Study to Determine Patient Satisfaction With Single-Use Prefilled Avonex® PEN Autoinjector in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT01366040
- Acronym / sponsor ID
- ASPECT / AVX-CAN-11-08
- Conditions
- Multiple Sclerosis
- Keywords
- Patient Satisfaction, Multiple Sclerosis, Autoinjector, Avonex
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 3 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient satisfaction
Time frame: 2 months
2 secondary outcomes
Ease of use grading scale
Time frame: 2 months
Autoinjector instructions grading scale
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Biogen at 10 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2013.