Status:
COMPLETED
Immunogenicity and Safety Study of Serum-Free Avonex
Lead Sponsor:
Biogen
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
To evaluate the immunogenicity of a serum-free pre-formulated solution of Avonex when given to interferon beta naive patients with relapsing/remitting multiple sclerosis.
Eligibility Criteria
Inclusion
- Must have a diagnosis of relapsing/remitting MS as defined by McDonald, et al15; criteria numbers 1-4.
- Must have an expanded disability status scale (EDSS) score between 0 and 5.5, inclusive.
- Must be able to understand and comply with the protocol.
Exclusion
- Has experienced a relapse within 2 months prior to Day 1. Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 48 hours, and accompanied by new objective neurological findings upon examination by the investigator.
- History of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease that would preclude therapy with interferon beta.
- Abnormal screening or baseline blood tests determined to be clinically significant by the investigator
- History of a seizure within 3 months prior to Day 1.
- History of suicidal ideation within 3 months prior to Day 1 or an episode of severe depression within 3 months prior to Day 1.
- Known allergy to natural rubber latex.
- Other inclusion and exclusion criteria apply as per protocol
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT00912860
Start Date
January 1 2003
End Date
January 1 2005
Last Update
June 10 2009
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