Multiple SclerosisCAPPSNCT01489748
Canadian Avonex PEN Productivity Study
An observational study of Multiple Sclerosis, run by Biogen at 1 site in Canada.
Trial summary
This study is primarily designed to evaluate the impact of AVONEX PEN autoinjector on work capacity of participants with multiple sclerosis (MS) starting on this device. This study will also evaluate as secondary endpoints various patient-reported outcomes over the short-term (1 month), including adherence, treatment… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 111 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2012to Dec 2014
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Enrollment will consist of approximately 500 participants who have been prescribed AVONEX PEN in accord with its labeling (Product Monograph). This will include participants who are naïve to disease modifying therapies (DMTs) as well as those who are being switched from another injectable DMT.
Who may be able to join
- Must be prescribed AVONEX PEN as per local labeling (Product Monograph) and enrolled in MS Alliance (MSA) program
- If being switched from another DMT, must be on this DMT for at least 6 months
- Last DMT the subject is switched from must be injectable
- Must be able to physically demonstrate use of the AVONEX PEN autoinjector device and be able to self-administer the injections
- 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 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
- Current enrollment in any investigational study involving drug, biologic or non-drug therapy
- Participation in other clinical studies within the past 6 months
- Treatment with immunosuppressive regimens (e.g. cyclophosphamide, azathioprine, methotrexate or mitoxantrone) or with intravenous immunoglobulin (IVIg) in the last 6 months
- The most recent DMT the subject is switched from is non-injectable (i.e., oral)
- Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrollment
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Observational, Multicenter Study to Evaluate the Impact of AVONEX PEN Autoinjector Therapy on Work Capacity of Multiple Sclerosis Patients in Canada
This study is primarily designed to evaluate the impact of AVONEX PEN autoinjector on work capacity of participants with multiple sclerosis (MS) starting on this device. This study will also evaluate as secondary endpoints various patient-reported outcomes over the short-term (1 month), including adherence, treatment satisfaction and convenience, and the long-term (12 and 24 months), including adherence, persistence, quality of life (QOL), treatment satisfaction and convenience. It will also assess health resource utilization by MS participants starting on AVONEX PEN autoinjector, as well as overall safety/tolerability, and will correlate all secondary outcomes with the primary (i.e., work capacity).
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in work capacity
Work capacity will be assessed by a telephone-based survey which consists of 10 questions asking participant's about the effect of MS on their ability to work and perform regular activities.
Measured: 2 years
Secondary outcomes (7)
Number of participants with hospital and emergency episodes of care
Measured: -1 year, 1 year
Number of missed injections
Measured: 1 month, 1 year, 2 years
Number of participants who discontinued treatment
Measured: 1 year, 2 years
Change from Baseline in Global Quality of life score
Quality of life will be assessed by a Multiple Sclerosis Quality of Life (MSQOL) questionnaire. This 54-item questionnaire addresses overall health and daily activities.
Measured: 1 year, 2 years
Change from Baseline in participants' satisfaction with the device
Participant satisfaction will be measured using a 10-item satisfaction questionnaire.
Measured: 1 month, 1 year, 2 years
Change from Baseline in ease of use of the device
Ease of use will be assessed on a scale from 0 (extremely difficult) to 10 (extremely easy).
Measured: 1 month, 1 year, 2 years
Number of participants with injection site reactions (ISRs)
Measured: 1 month, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2011 (estimated)
- Study startMar 2012
- Primary completionOct 2014
- Study completionDec 2014
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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489748
- Sponsor's protocol ID
- CAN-AVX-11-10239
- Acronym
- CAPPS
- Status last verified
- Feb 2015
- First submitted
- 1 Dec 2011
- Last updated
- 20 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Observational, Multicenter Study to Evaluate the Impact of AVONEX PEN Autoinjector Therapy on Work Capacity of Multiple Sclerosis Patients in Canada
- ClinicalTrials.gov ID
- NCT01489748
- Acronym / sponsor ID
- CAPPS / CAN-AVX-11-10239
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 12 Dec 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 study is primarily designed to evaluate the impact of AVONEX PEN autoinjector on work capacity of participants with multiple sclerosis (MS) starting on this device. This study will also evaluate as secondary endpoints various patient-reported outcomes over the short-term (1 month), including adherence, treatment satisfaction and convenience, and the long-term (12 and 24 months), including adherence, persistence, quality of life (QOL), treatment satisfaction and convenience. It will also assess health resource utilization by MS participants starting on AVONEX PEN autoinjector, as well as overall safety/tolerability, and will correlate all secondary outcomes with the primary (i.e., work capacity).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Enrollment will consist of approximately 500 participants who have been prescribed AVONEX PEN in accord with its labeling (Product Monograph). This will include participants who are naïve to disease modifying therapies (DMTs) as well as those who are being switched from another injectable DMT.
Key inclusion criteria (6 listed)
- Must be prescribed AVONEX PEN as per local labeling (Product Monograph) and enrolled in MS Alliance (MSA) program
- If being switched from another DMT, must be on this DMT for at least 6 months
- Last DMT the subject is switched from must be injectable
- Must be able to physically demonstrate use of the AVONEX PEN autoinjector device and be able to self-administer the injections
- Must give written informed consent. If required by local law, candidates must also authorize the release and use of protected health information (PHI)
Key exclusion criteria (7 listed)
- Female subjects considering becoming pregnant while in the study or who are currently pregnant or breast-feeding
- Current enrollment in any investigational study involving drug, biologic or non-drug therapy
- Participation in other clinical studies within the past 6 months
- Treatment with immunosuppressive regimens (e.g. cyclophosphamide, azathioprine, methotrexate or mitoxantrone) or with intravenous immunoglobulin (IVIg) in the last 6 months
- The most recent DMT the subject is switched from is non-injectable (i.e., oral)
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
Change from Baseline in work capacity
Time frame: 2 years
Work capacity will be assessed by a telephone-based survey which consists of 10 questions asking participant's about the effect of MS on their ability to work and perform regular activities.
7 secondary outcomes
Number of participants with hospital and emergency episodes of care
Time frame: -1 year, 1 year
Number of missed injections
Time frame: 1 month, 1 year, 2 years
Number of participants who discontinued treatment
Time frame: 1 year, 2 years
Change from Baseline in Global Quality of life score
Time frame: 1 year, 2 years
Change from Baseline in participants' satisfaction with the device
Time frame: 1 month, 1 year, 2 years
Change from Baseline in ease of use of the device
Time frame: 1 month, 1 year, 2 years
Number of participants with injection site reactions (ISRs)
Time frame: 1 month, 1 year, 2 years
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 20 Feb 2015.
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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.
Medical Director study director
Biogen
1 site 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 1 site 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 6 inclusion and 7 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 20 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change from Baseline in work capacity (time frame: 2 years). 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 20 Feb 2015.