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

Biogen

Status and phase

Completed

Phase 3

Conditions

Multiple Sclerosis

Treatments

Device: Single-use autoinjector

Drug: Interferon beta-1a

Study type

Interventional

Funder types

Industry

Identifiers

C-872

Details and patient eligibility

About

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

Enrollment

74 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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 exclusion criteria apply as per Biogen Idec Protocol