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

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00915577
First received: June 5, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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 Idec:

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915577

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

No publications provided

Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00915577     History of Changes
Other Study ID Numbers: C-872
Study First Received: June 5, 2009
Last Updated: June 5, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 29, 2014