NCT00915577CompletedPhase 3
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Biogen
- Enrollment
- 74
- Primary Endpoint
- The primary objective of the study is to determine patient satisfaction with the single-use autoinjector for the delivery of pre-filled AVONEX® syringe
Study Overview
Brief Summary
Determine patient satisfaction with the single-use autoinjector for the delivery of pre-filled Avonex syringe.
Study Design
- Study Type
- Interventional
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1st Injection
Experimental
Manual injection with pre-filled syringe.
Intervention: Interferon beta-1a (Drug)
Single-use autoinjector
Experimental
Single-use autoinjector with Avonex pre-filled syringe
Intervention: Single-use autoinjector (Device)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Similar Trials
Completed
Phase 3
Usability of an AI for M923 in Subjects With Moderate to Severe RARheumatoid ArthritisNCT02722044Momenta Pharmaceuticals, Inc.33
Completed
Phase 2
An Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid ArthritisRheumatoid ArthritisNCT03193957Samsung Bioepis Co., Ltd.50
Completed
Phase 3
A Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-injector for the Subcutaneous Self-injection of Bimekizumab Solution by Subjects With Active Psoriatic ArthritisPsoriatic ArthritisNCT04109976UCB Biopharma SRL214
Completed
Phase 3
Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for EtanerceptPsoriasisNCT00482170Pfizer421
Recruiting
Phase 1
Compare the Auto-injector and Pre-filled Syringe of CT-P47 in Healthy SubjectsHealthy SubjectsNCT05617183Celltrion268