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

June 5, 2009 updated by: Biogen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1st Injection
Manual injection with pre-filled syringe.
Drug: Interferon beta-1a
30mcg, IM once-a-week
Other Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
The study duration is 8 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (ACTUAL)

April 1, 2006

Study Completion (ACTUAL)

April 1, 2006

Study Registration Dates

First Submitted

June 5, 2009

First Submitted That Met QC Criteria

June 5, 2009

First Posted (ESTIMATE)

June 8, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 8, 2009

Last Update Submitted That Met QC Criteria

June 5, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-872

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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