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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00915577
First Posted: June 8, 2009
Last Update Posted: June 8, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Biogen
  Purpose
Determine patient satisfaction with the single-use autoinjector for the delivery of pre-filled Avonex syringe.

Condition Intervention Phase
Multiple Sclerosis Drug: Interferon beta-1a Device: Single-use autoinjector Phase 3

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: None (Open Label)
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

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • The primary objective of the study is to determine patient satisfaction with the single-use autoinjector for the delivery of pre-filled AVONEX® syringe [ Time Frame: The study duration is 8 Weeks ]

Enrollment: 74
Study Start Date: August 2005
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1st Injection
Manual injection with pre-filled syringe.
Drug: Interferon beta-1a
30mcg, IM once-a-week
Other Name: Avonex
Experimental: Single-use autoinjector
Single-use autoinjector with Avonex pre-filled syringe
Device: Single-use autoinjector
Single-use autoinjector with Avonex 30mcg pre-filled syringe

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00915577


Sponsors and Collaborators
Biogen
Investigators
Study Director: Biogen-Idec Investigator Biogen
  More Information

Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00915577     History of Changes
Other Study ID Numbers: C-872
First Submitted: June 5, 2009
First Posted: June 8, 2009
Last Update Posted: June 8, 2009
Last Verified: June 2009

Keywords provided by Biogen:
Multiple Sclerosis
interferon beta-1a
Avonex
liquid Avonex

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon-beta
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic