DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Canadian Avonex PEN Productivity Study

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Phase: N/A

Status: Completed

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Biogen

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 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).

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Change from Baseline in work capacity

Secondary outcome:

Number of participants with hospital and emergency episodes of care

Number of missed injections

Number of participants who discontinued treatment

Change from Baseline in Global Quality of life score

Change from Baseline in participants' satisfaction with the device

Change from Baseline in ease of use of the device

Number of participants with injection site reactions (ISRs)

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

Key Inclusion Criteria:

- 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 Criteria:

- 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.

Locations and Contacts

Central Contact, Burlington, Ontario, Canada
Additional Information

Starting date: March 2012
Last updated: February 18, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017