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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2006-04-30

Brief Summary

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

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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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1st Injection

Manual injection with pre-filled syringe.

Group Type EXPERIMENTAL

Interferon beta-1a

Intervention Type DRUG

30mcg, IM once-a-week

Single-use autoinjector

Single-use autoinjector with Avonex pre-filled syringe

Group Type EXPERIMENTAL

Single-use autoinjector

Intervention Type DEVICE

Single-use autoinjector with Avonex 30mcg pre-filled syringe

Interventions

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Interferon beta-1a

30mcg, IM once-a-week

Intervention Type DRUG

Single-use autoinjector

Single-use autoinjector with Avonex 30mcg pre-filled syringe

Intervention Type DEVICE

Other Intervention Names

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Avonex

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No