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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00915577
• Other study ID #: C-872
• Status: Completed
• Phase: Phase 3
• First received: June 5, 2009
• Last updated: June 5, 2009
• Start date: August 2005
• Est. completion date: April 2006

Study information

• Verified date: June 2009
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Interferon beta-1a
30mcg, IM once-a-week

Device:
• Single-use autoinjector
Single-use autoinjector with Avonex 30mcg pre-filled syringe

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No