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

Phase 3

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Interferon beta-1a; Device: Single-use autoinjector

• Registration Number: NCT00915577
• Lead Sponsor: Biogen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Status Verified: 2009-06
• Study First Submitted: 2009-06-05
• Study First Submitted QC: 2009-06-05
• Last Update Submitted: 2009-06-05
• Study First Posted: 2009-06-08
• Last Update Posted: 2009-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1st Injection	Interferon beta-1a	Manual injection with pre-filled syringe.
Single-use autoinjector	Single-use autoinjector	Single-use autoinjector with Avonex pre-filled syringe

Primary Outcome Measures

Name	Time	Method
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