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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00915577

Enrollment

Registered

2009-06-08

Start date

2005-08-31

Completion date

2006-04-30

Last updated

2009-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, interferon beta-1a, Avonex, liquid Avonex

Brief summary

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

Interventions

DRUGInterferon beta-1a

30mcg, IM once-a-week

DEVICESingle-use autoinjector

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

Study design

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026