Patient Satisfaction Study of Single-Use Autoinjector for the Delivery of Pre-Filled Avonex Syringe

Study Overview
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Brief Summary
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Determine patient satisfaction with the single-use autoinjector for the delivery of pre-filled Avonex syringe.

Official Title
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An Open-Label, Multicenter Study to Determine Subject Satisfaction in Using the Single-Use Autoinjector With a Pre-Filled Liquid AVONEX® Syringe in Multiple Sclerosis Subjects

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Interferon beta-1a
* Device: Single-use autoinjector


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be using liquid AVONEX® to treat MS. In addition, the subject must be on liquid AVONEX® for 12 weeks prior to the Screening Visit. Must have a BMI of 19 to 28 kg/m², inclusive, and a minimum body weight of 50 kg at Screening. Must be able to physically demonstrate use of the device and be able to self-administer all injections. Must be English speaking. Must be able to understand and comply with the protocol. Exclusion Criteria: Abnormal screening or screening blood tests determined to be clinically significant by the investigator for: white blood count (WBC) or differential, platelet count, hemoglobin, serum creatinine, bilirubin, alanine transaminase (ALT) aspartate transaminase (AST), prothrombin time (PT). Known sensitivity to dry natural rubber. Treatment with other agents to treat MS symptoms or underlying disease as specified in the protocol. History of severe allergic or anaphylactic reactions. History of intolerance to acetaminophen (paracetamol), ibuprofen, naproxen, and aspirin that would preclude the use of at least one of these during the study. Serious local infection Other inclusion and exclusion criteria apply as per Biogen Idec Protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1st Injection<br>Manual injection with pre-filled syringe. | Drug: Interferon beta-1a<br>* 30mcg, IM once-a-week<br>* Other names: Avonex;|
| Experimental: Single-use autoinjector<br>Single-use autoinjector with Avonex pre-filled syringe | Device: Single-use autoinjector<br>* Single-use autoinjector with Avonex 30mcg pre-filled syringe<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of the study is to determine patient satisfaction with the single-use autoinjector for the delivery of pre-filled AVONEX® syringe |  | The study duration is 8 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Avonex, Multiple Sclerosis, interferon beta-1a, liquid Avonex