Status:
COMPLETED
Canadian Avonex PEN Productivity Study
Lead Sponsor:
Biogen
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-50 years
Brief 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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT01489748
Start Date
March 1 2012
End Date
December 1 2014
Last Update
February 20 2015
Active Locations (1)
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1
Central Contact
Burlington, Ontario, Canada