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

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Treatments: Interferon beta-1a; Interferon-beta; Interferons

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/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