Patient Satisfaction Study of Single-Use Autoinjector for the Delivery
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
What it found
We found no results in the registry or in papers.
This trial finished 20 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Interferon beta-1a
Interferon alpha/beta receptor agonist
- Single-use autoinjector
What it measured
Main 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
The study duration is 8 Weeks
Quality of life (reported by participants)
Who could take part
MS (type not specified) · 18 to 65
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Determine patient satisfaction with the single-use autoinjector for the delivery of pre-filled Avonex syringe.
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History
Started
Aug 2005
Main results due
Apr 2006
Finished
Apr 2006