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

Information source: Biogen
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: Interferon beta-1a (Drug); Single-use autoinjector (Device)

Phase: Phase 3

Status: Completed

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Biogen-Idec Investigator, Study Director, Affiliation: Biogen

Summary

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

Clinical Details

Official title: 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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: The primary objective of the study is to determine patient satisfaction with the single-use autoinjector for the delivery of pre-filled AVONEX® syringe

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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/m┬▓, 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

Locations and Contacts

Additional Information

Starting date: August 2005
Last updated: June 5, 2009

Page last updated: August 20, 2015

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