Status:
COMPLETED
Patient Satisfaction Study of Single-Use Autoinjector for the Delivery of Pre-Filled Avonex Syringe
Lead Sponsor:
Biogen
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Determine patient satisfaction with the single-use autoinjector for the delivery of pre-filled Avonex syringe.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00915577
Start Date
August 1 2005
End Date
April 1 2006
Last Update
June 8 2009
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