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

NCT00915577 | Completed Phase 3

• 1 other identifier: C-872
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; interferon beta-1a; Avonex; liquid Avonex

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1st Injection

EXPERIMENTAL

Manual injection with pre-filled syringe.

Drug: Interferon beta-1a

Single-use autoinjector

EXPERIMENTAL

Single-use autoinjector with Avonex pre-filled syringe

Device: Single-use autoinjector

Interventions

Interferon beta-1a DRUG

30mcg, IM once-a-week

Also known as: Avonex

1st Injection

Single-use autoinjector DEVICE

Single-use autoinjector with Avonex 30mcg pre-filled syringe

Single-use autoinjector

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Biogen: lead

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Biogen-Idec Investigator

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 5, 2009
• First Posted: June 8, 2009
• Study Start: August 1, 2005
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: June 8, 2009

Record last verified: 2009-06